Megan Brooks

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

A version of this article first appeared on Medscape.com.

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

A version of this article first appeared on Medscape.com.

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 reperfusion catheter with Xtra Flex technology (JET 7 Xtra Flex), owing to the risk for “unexpected death or serious injury” during use for clot removal in stroke patients.

“All users should stop using this device, and facilities should remove these devices from inventory,” the recall notice, posted on the U.S. Food and Drug Administration website, advises.

The recall covers the JET 7 Xtra Flex catheter, which was cleared for use in June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), which was cleared in February of this year.

The recall does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.

The FDA says it has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including reports of deaths, serious injuries, and malfunctions.

Twenty of these MDRs describe 14 unique patient deaths. Other MDRs describe serious patient injury, such as vessel damage, hemorrhage, and cerebral infarction.

Device malfunctions described in the reports include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.

According to the FDA, bench testing by the manufacturer, in which the catheter distal tip is plugged and pressurized to failure, indicates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus for patients with acute ischemic stroke.

Penumbra’s urgent medical device recall letter advises health care providers and facilities to remove and quarantine all unused devices covered by this recall, to complete the product identification and return form, and to return all products to Penumbra in accordance with instructions provided.

For questions regarding this recall, contact Penumbra customer service by phone at 888-272-4606 or by email at [email protected].

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

A version of this article first appeared on Medscape.com.

Middle-aged women with PTSD and comorbid depression have a nearly fourfold increased risk for early death from a variety of causes in comparison with their peers who do not have those conditions, new research shows.

“Women with more severe symptoms of depression and PTSD were more at risk, compared with those with fewer symptoms or women with symptoms of only PTSD or only depression,” lead investigator Andrea Roberts, PhD, Harvard School of Public Health, Boston, said in an interview.

Health care providers “should be aware that mental health is a critical component of overall health and is tightly entwined with physical health. Identifying and treating mental health issues should be a foundational part of general health practice,” said Dr. Roberts.

The study was published online Dec. 4 in JAMA Network Open.
 

Mental health fundamental to survival

The researchers studied more than 51,000 mostly White women from the Nurses Health Study II who were followed for 9 years (2008-2017). At baseline in 2008, the women were aged between 43 and 64 years (mean age, 53.3 years).

Women with high levels of PTSD (six or seven symptoms) and probable depression were nearly four times more likely to die during follow-up than their peers who did not have these conditions (hazard ratio, 3.8; 95% confidence interval, 2.65-5.45; P < .001).

With adjustment for health factors such as smoking and body mass index, women with a high level of PTSD and depression remained at increased risk for early death (HR, 3.11; 95% CI, 2.16-4.47; P < .001).

The risk for early death was also elevated among women with moderate PTSD (four or five symptoms) and depression (HR, 2.03; 95% CI, 1.35-3.03; P < .001) and women with subclinical PTSD and depression (HR, 2.85; 95% CI, 1.99-4.07; P < .001) compared with those who did not have PTSD or depression.

Among women with PTSD symptoms and depression, the incidence of death from nearly all major causes was increased, including death from cardiovascular disease, respiratory disease, type 2 diabetes, unintentional injury, suicide, and other causes.

“These findings provide further evidence that mental health is fundamental to physical health – and to our very survival. We ignore our emotional well-being at our peril,” senior author Karestan Koenen, PhD, said in a news release.
 

New knowledge

Commenting on the findings, Jennifer Sumner, PhD, said that it’s “critical to appreciate the physical health consequences of psychopathology in individuals who have experienced trauma. This study adds to a growing literature demonstrating that the impact extends far beyond emotional health.

“Furthermore, these results highlight the potential value of promoting healthy lifestyle changes in order to reduce the elevated mortality risk in trauma-exposed individuals with co-occurring PTSD and depression,” said Dr. Sumner, who is with the department of psychology, University of California, Los Angeles.

She noted that this study builds on other work that links PTSD to mortality in men.

“Most work on posttraumatic psychopathology and physical health has actually been conducted in predominantly male samples of veterans, so these findings in women exposed to a variety of traumatic experiences extend the literature in important ways,” said Dr. Sumner.

“It’s also important to note that PTSD and depression are more prevalent in women than in men, so demonstrating these associations in women is particularly relevant,” she added.

Funding for the study was provided by the National Institutes of Heath. The authors disclosed no relevant financial relationships. Dr. Sumner has collaborated with the study investigators on prior studies.

A version of this article originally appeared on Medscape.com.

Middle-aged women with PTSD and comorbid depression have a nearly fourfold increased risk for early death from a variety of causes in comparison with their peers who do not have those conditions, new research shows.

“Women with more severe symptoms of depression and PTSD were more at risk, compared with those with fewer symptoms or women with symptoms of only PTSD or only depression,” lead investigator Andrea Roberts, PhD, Harvard School of Public Health, Boston, said in an interview.

Health care providers “should be aware that mental health is a critical component of overall health and is tightly entwined with physical health. Identifying and treating mental health issues should be a foundational part of general health practice,” said Dr. Roberts.

The study was published online Dec. 4 in JAMA Network Open.
 

Mental health fundamental to survival

The researchers studied more than 51,000 mostly White women from the Nurses Health Study II who were followed for 9 years (2008-2017). At baseline in 2008, the women were aged between 43 and 64 years (mean age, 53.3 years).

Women with high levels of PTSD (six or seven symptoms) and probable depression were nearly four times more likely to die during follow-up than their peers who did not have these conditions (hazard ratio, 3.8; 95% confidence interval, 2.65-5.45; P < .001).

With adjustment for health factors such as smoking and body mass index, women with a high level of PTSD and depression remained at increased risk for early death (HR, 3.11; 95% CI, 2.16-4.47; P < .001).

The risk for early death was also elevated among women with moderate PTSD (four or five symptoms) and depression (HR, 2.03; 95% CI, 1.35-3.03; P < .001) and women with subclinical PTSD and depression (HR, 2.85; 95% CI, 1.99-4.07; P < .001) compared with those who did not have PTSD or depression.

Among women with PTSD symptoms and depression, the incidence of death from nearly all major causes was increased, including death from cardiovascular disease, respiratory disease, type 2 diabetes, unintentional injury, suicide, and other causes.

“These findings provide further evidence that mental health is fundamental to physical health – and to our very survival. We ignore our emotional well-being at our peril,” senior author Karestan Koenen, PhD, said in a news release.
 

New knowledge

Commenting on the findings, Jennifer Sumner, PhD, said that it’s “critical to appreciate the physical health consequences of psychopathology in individuals who have experienced trauma. This study adds to a growing literature demonstrating that the impact extends far beyond emotional health.

“Furthermore, these results highlight the potential value of promoting healthy lifestyle changes in order to reduce the elevated mortality risk in trauma-exposed individuals with co-occurring PTSD and depression,” said Dr. Sumner, who is with the department of psychology, University of California, Los Angeles.

She noted that this study builds on other work that links PTSD to mortality in men.

“Most work on posttraumatic psychopathology and physical health has actually been conducted in predominantly male samples of veterans, so these findings in women exposed to a variety of traumatic experiences extend the literature in important ways,” said Dr. Sumner.

“It’s also important to note that PTSD and depression are more prevalent in women than in men, so demonstrating these associations in women is particularly relevant,” she added.

Funding for the study was provided by the National Institutes of Heath. The authors disclosed no relevant financial relationships. Dr. Sumner has collaborated with the study investigators on prior studies.

A version of this article originally appeared on Medscape.com.

Middle-aged women with PTSD and comorbid depression have a nearly fourfold increased risk for early death from a variety of causes in comparison with their peers who do not have those conditions, new research shows.

“Women with more severe symptoms of depression and PTSD were more at risk, compared with those with fewer symptoms or women with symptoms of only PTSD or only depression,” lead investigator Andrea Roberts, PhD, Harvard School of Public Health, Boston, said in an interview.

Health care providers “should be aware that mental health is a critical component of overall health and is tightly entwined with physical health. Identifying and treating mental health issues should be a foundational part of general health practice,” said Dr. Roberts.

The study was published online Dec. 4 in JAMA Network Open.
 

Mental health fundamental to survival

The researchers studied more than 51,000 mostly White women from the Nurses Health Study II who were followed for 9 years (2008-2017). At baseline in 2008, the women were aged between 43 and 64 years (mean age, 53.3 years).

Women with high levels of PTSD (six or seven symptoms) and probable depression were nearly four times more likely to die during follow-up than their peers who did not have these conditions (hazard ratio, 3.8; 95% confidence interval, 2.65-5.45; P < .001).

With adjustment for health factors such as smoking and body mass index, women with a high level of PTSD and depression remained at increased risk for early death (HR, 3.11; 95% CI, 2.16-4.47; P < .001).

The risk for early death was also elevated among women with moderate PTSD (four or five symptoms) and depression (HR, 2.03; 95% CI, 1.35-3.03; P < .001) and women with subclinical PTSD and depression (HR, 2.85; 95% CI, 1.99-4.07; P < .001) compared with those who did not have PTSD or depression.

Among women with PTSD symptoms and depression, the incidence of death from nearly all major causes was increased, including death from cardiovascular disease, respiratory disease, type 2 diabetes, unintentional injury, suicide, and other causes.

“These findings provide further evidence that mental health is fundamental to physical health – and to our very survival. We ignore our emotional well-being at our peril,” senior author Karestan Koenen, PhD, said in a news release.
 

New knowledge

Commenting on the findings, Jennifer Sumner, PhD, said that it’s “critical to appreciate the physical health consequences of psychopathology in individuals who have experienced trauma. This study adds to a growing literature demonstrating that the impact extends far beyond emotional health.

“Furthermore, these results highlight the potential value of promoting healthy lifestyle changes in order to reduce the elevated mortality risk in trauma-exposed individuals with co-occurring PTSD and depression,” said Dr. Sumner, who is with the department of psychology, University of California, Los Angeles.

She noted that this study builds on other work that links PTSD to mortality in men.

“Most work on posttraumatic psychopathology and physical health has actually been conducted in predominantly male samples of veterans, so these findings in women exposed to a variety of traumatic experiences extend the literature in important ways,” said Dr. Sumner.

“It’s also important to note that PTSD and depression are more prevalent in women than in men, so demonstrating these associations in women is particularly relevant,” she added.

Funding for the study was provided by the National Institutes of Heath. The authors disclosed no relevant financial relationships. Dr. Sumner has collaborated with the study investigators on prior studies.

A version of this article originally appeared on Medscape.com.

Serious neurologic complications in patients with COVID-19 are not limited to the severely ill, new research confirms.

“We found a range of neurologic diagnoses, including stroke and seizures, among hospitalized patients with COVID-19 and the majority were not critically ill, suggesting that these complications are not limited just to those patients who require ICU care or a ventilator,” study investigator Pria Anand, MD, division of neuro-infectious diseases, Boston University, said in an interview.

The study was published online Dec. 9 in Neurology Clinical Practice.
 

‘Moderately severe’ disability

For the study, the investigators reviewed the medical records of 74 adults (mean age, 64 years) who were hospitalized with COVID-19 and evaluated for neurologic conditions at Boston Medical Center, a safety-net hospital caring primarily for underserved, low-income, racial and ethnic minority populations.

The most common COVID-19 symptoms on arrival to the hospital were cough (39%), dyspnea (36%), and fever (34%). Eleven patients required intubation (15%) and 28 required some form of supplemental oxygen (38%). Thirty-four patients required intensive care (46%).

The most common neurologic COVID-19 symptoms at presentation were altered mental status (53%), myalgia (24%), fatigue (24%), and headache (18%). 

After neurologic assessment, the most common final neurologic diagnosis was multifactorial or toxic-metabolic encephalopathy (35%), followed by seizure (20%), ischemic stroke (20%), primary movement disorder (9%), peripheral neuropathy (8%), and hemorrhagic stroke (4%).

Three patients (4%) suffered traumatic brain injuries after falling in their homes after developing COVID-19.

Ten (14%) patients died in the hospital. Survivors had “moderately severe” disability at discharge (median modified Rankin Scale score of 4 from a preadmission mRS score of 2) and many were discharged to nursing facilities or rehabilitation hospitals.

“Although we do not have data on their posthospital course, this suggests that patients with neurologic complications of COVID-19 are likely to require ongoing rehabilitation, even after they leave the hospital,” Dr. Anand, a member of the American Academy of Neurology, said in an interview.

“There are a diverse range of mechanisms by which COVID-19 can cause neurologic complications,” Dr. Anand said.

“These complications can result from the body’s immunological response to the virus (e.g., Guillain-Barré syndrome, an autoimmune disorder affecting the nerves), from having a systemic severe illness (e.g., brain injury as a result of insufficient oxygenation), from the increased tendency to form blood clots (e.g., stroke), from worsening of preexisting neurologic disorders, and possibly from involvement of the nervous system by the virus itself,” she explained.

The researchers said more study is needed to characterize the infectious and postinfectious neurologic complications of COVID-19 in diverse patient populations.
 

Lingering issues

In an interview, Kenneth L. Tyler, MD, chair of neurology, University of Colorado, Denver, noted that this is one of the larger series published to date of the neurologic complications associated with COVID-19, and the first to come from a U.S. safety-net hospital in a large metropolitan area.

“Overall, the types and categories of neurological complications reported including encephalopathy (35%) and acute cerebrovascular events (~20%) are similar to those reported elsewhere,” said Dr. Tyler.

However, the frequency of stroke (~20%) is higher than in some other reports, “likely reflecting the comorbidities such as diabetes, hypertension, limited access to care [that are] present in this population,” he said.

Dr. Tyler also noted that the “relatively high frequency” of primary movement disorders, notably myoclonus, “hasn’t been particularly well recognized or described, although one of the authors has written on this in COVID-19, so perhaps there is a bit of an ‘ascertainment bias’ – as they were looking harder for it?”

Finally, he noted, it’s important to understand that all the published studies “vary tremendously in the populations they examine, so direct comparisons can be difficult.”

Also weighing in on the report in an interview, Richard Temes, MD, director, Northwell Health’s Center for Neurocritical Care in Manhasset, N.Y., said neurologic problems have been noted since the start of COVID-19 and have been well described.

“It’s common for patients to present with very nonspecific neurological complaints like confusion, disorientation, altered mental status, lethargy, but also neurological disease such as strokes, brain hemorrhages, and seizures are quite common as well,” said Dr. Temes. 

He also noted that a number of patients with COVID-19 will have “lingering effects, especially patients who are hospitalized, that can range from memory deficit, cognitive slowing, and trouble with activities of daily living and depression.

“These effects can occur with any patient who is hospitalized for a [significant] period of time, especially in the intensive care unit, so it’s hard to tease out whether or not this is truly from COVID itself or if it’s just being a survivor from a very severe, critical illness. We don’t know yet. We need more data on that,” he cautioned.
 

A version of this article originally appeared on Medscape.com.

Serious neurologic complications in patients with COVID-19 are not limited to the severely ill, new research confirms.

“We found a range of neurologic diagnoses, including stroke and seizures, among hospitalized patients with COVID-19 and the majority were not critically ill, suggesting that these complications are not limited just to those patients who require ICU care or a ventilator,” study investigator Pria Anand, MD, division of neuro-infectious diseases, Boston University, said in an interview.

The study was published online Dec. 9 in Neurology Clinical Practice.
 

‘Moderately severe’ disability

For the study, the investigators reviewed the medical records of 74 adults (mean age, 64 years) who were hospitalized with COVID-19 and evaluated for neurologic conditions at Boston Medical Center, a safety-net hospital caring primarily for underserved, low-income, racial and ethnic minority populations.

The most common COVID-19 symptoms on arrival to the hospital were cough (39%), dyspnea (36%), and fever (34%). Eleven patients required intubation (15%) and 28 required some form of supplemental oxygen (38%). Thirty-four patients required intensive care (46%).

The most common neurologic COVID-19 symptoms at presentation were altered mental status (53%), myalgia (24%), fatigue (24%), and headache (18%). 

After neurologic assessment, the most common final neurologic diagnosis was multifactorial or toxic-metabolic encephalopathy (35%), followed by seizure (20%), ischemic stroke (20%), primary movement disorder (9%), peripheral neuropathy (8%), and hemorrhagic stroke (4%).

Three patients (4%) suffered traumatic brain injuries after falling in their homes after developing COVID-19.

Ten (14%) patients died in the hospital. Survivors had “moderately severe” disability at discharge (median modified Rankin Scale score of 4 from a preadmission mRS score of 2) and many were discharged to nursing facilities or rehabilitation hospitals.

“Although we do not have data on their posthospital course, this suggests that patients with neurologic complications of COVID-19 are likely to require ongoing rehabilitation, even after they leave the hospital,” Dr. Anand, a member of the American Academy of Neurology, said in an interview.

“There are a diverse range of mechanisms by which COVID-19 can cause neurologic complications,” Dr. Anand said.

“These complications can result from the body’s immunological response to the virus (e.g., Guillain-Barré syndrome, an autoimmune disorder affecting the nerves), from having a systemic severe illness (e.g., brain injury as a result of insufficient oxygenation), from the increased tendency to form blood clots (e.g., stroke), from worsening of preexisting neurologic disorders, and possibly from involvement of the nervous system by the virus itself,” she explained.

The researchers said more study is needed to characterize the infectious and postinfectious neurologic complications of COVID-19 in diverse patient populations.
 

Lingering issues

In an interview, Kenneth L. Tyler, MD, chair of neurology, University of Colorado, Denver, noted that this is one of the larger series published to date of the neurologic complications associated with COVID-19, and the first to come from a U.S. safety-net hospital in a large metropolitan area.

“Overall, the types and categories of neurological complications reported including encephalopathy (35%) and acute cerebrovascular events (~20%) are similar to those reported elsewhere,” said Dr. Tyler.

However, the frequency of stroke (~20%) is higher than in some other reports, “likely reflecting the comorbidities such as diabetes, hypertension, limited access to care [that are] present in this population,” he said.

Dr. Tyler also noted that the “relatively high frequency” of primary movement disorders, notably myoclonus, “hasn’t been particularly well recognized or described, although one of the authors has written on this in COVID-19, so perhaps there is a bit of an ‘ascertainment bias’ – as they were looking harder for it?”

Finally, he noted, it’s important to understand that all the published studies “vary tremendously in the populations they examine, so direct comparisons can be difficult.”

Also weighing in on the report in an interview, Richard Temes, MD, director, Northwell Health’s Center for Neurocritical Care in Manhasset, N.Y., said neurologic problems have been noted since the start of COVID-19 and have been well described.

“It’s common for patients to present with very nonspecific neurological complaints like confusion, disorientation, altered mental status, lethargy, but also neurological disease such as strokes, brain hemorrhages, and seizures are quite common as well,” said Dr. Temes. 

He also noted that a number of patients with COVID-19 will have “lingering effects, especially patients who are hospitalized, that can range from memory deficit, cognitive slowing, and trouble with activities of daily living and depression.

“These effects can occur with any patient who is hospitalized for a [significant] period of time, especially in the intensive care unit, so it’s hard to tease out whether or not this is truly from COVID itself or if it’s just being a survivor from a very severe, critical illness. We don’t know yet. We need more data on that,” he cautioned.
 

A version of this article originally appeared on Medscape.com.

Serious neurologic complications in patients with COVID-19 are not limited to the severely ill, new research confirms.

“We found a range of neurologic diagnoses, including stroke and seizures, among hospitalized patients with COVID-19 and the majority were not critically ill, suggesting that these complications are not limited just to those patients who require ICU care or a ventilator,” study investigator Pria Anand, MD, division of neuro-infectious diseases, Boston University, said in an interview.

The study was published online Dec. 9 in Neurology Clinical Practice.
 

‘Moderately severe’ disability

For the study, the investigators reviewed the medical records of 74 adults (mean age, 64 years) who were hospitalized with COVID-19 and evaluated for neurologic conditions at Boston Medical Center, a safety-net hospital caring primarily for underserved, low-income, racial and ethnic minority populations.

The most common COVID-19 symptoms on arrival to the hospital were cough (39%), dyspnea (36%), and fever (34%). Eleven patients required intubation (15%) and 28 required some form of supplemental oxygen (38%). Thirty-four patients required intensive care (46%).

The most common neurologic COVID-19 symptoms at presentation were altered mental status (53%), myalgia (24%), fatigue (24%), and headache (18%). 

After neurologic assessment, the most common final neurologic diagnosis was multifactorial or toxic-metabolic encephalopathy (35%), followed by seizure (20%), ischemic stroke (20%), primary movement disorder (9%), peripheral neuropathy (8%), and hemorrhagic stroke (4%).

Three patients (4%) suffered traumatic brain injuries after falling in their homes after developing COVID-19.

Ten (14%) patients died in the hospital. Survivors had “moderately severe” disability at discharge (median modified Rankin Scale score of 4 from a preadmission mRS score of 2) and many were discharged to nursing facilities or rehabilitation hospitals.

“Although we do not have data on their posthospital course, this suggests that patients with neurologic complications of COVID-19 are likely to require ongoing rehabilitation, even after they leave the hospital,” Dr. Anand, a member of the American Academy of Neurology, said in an interview.

“There are a diverse range of mechanisms by which COVID-19 can cause neurologic complications,” Dr. Anand said.

“These complications can result from the body’s immunological response to the virus (e.g., Guillain-Barré syndrome, an autoimmune disorder affecting the nerves), from having a systemic severe illness (e.g., brain injury as a result of insufficient oxygenation), from the increased tendency to form blood clots (e.g., stroke), from worsening of preexisting neurologic disorders, and possibly from involvement of the nervous system by the virus itself,” she explained.

The researchers said more study is needed to characterize the infectious and postinfectious neurologic complications of COVID-19 in diverse patient populations.
 

Lingering issues

In an interview, Kenneth L. Tyler, MD, chair of neurology, University of Colorado, Denver, noted that this is one of the larger series published to date of the neurologic complications associated with COVID-19, and the first to come from a U.S. safety-net hospital in a large metropolitan area.

“Overall, the types and categories of neurological complications reported including encephalopathy (35%) and acute cerebrovascular events (~20%) are similar to those reported elsewhere,” said Dr. Tyler.

However, the frequency of stroke (~20%) is higher than in some other reports, “likely reflecting the comorbidities such as diabetes, hypertension, limited access to care [that are] present in this population,” he said.

Dr. Tyler also noted that the “relatively high frequency” of primary movement disorders, notably myoclonus, “hasn’t been particularly well recognized or described, although one of the authors has written on this in COVID-19, so perhaps there is a bit of an ‘ascertainment bias’ – as they were looking harder for it?”

Finally, he noted, it’s important to understand that all the published studies “vary tremendously in the populations they examine, so direct comparisons can be difficult.”

Also weighing in on the report in an interview, Richard Temes, MD, director, Northwell Health’s Center for Neurocritical Care in Manhasset, N.Y., said neurologic problems have been noted since the start of COVID-19 and have been well described.

“It’s common for patients to present with very nonspecific neurological complaints like confusion, disorientation, altered mental status, lethargy, but also neurological disease such as strokes, brain hemorrhages, and seizures are quite common as well,” said Dr. Temes. 

He also noted that a number of patients with COVID-19 will have “lingering effects, especially patients who are hospitalized, that can range from memory deficit, cognitive slowing, and trouble with activities of daily living and depression.

“These effects can occur with any patient who is hospitalized for a [significant] period of time, especially in the intensive care unit, so it’s hard to tease out whether or not this is truly from COVID itself or if it’s just being a survivor from a very severe, critical illness. We don’t know yet. We need more data on that,” he cautioned.
 

A version of this article originally appeared on Medscape.com.

The American College of Cardiology and American Heart Association Task Force on Performance Measures have made two changes to performance measures for adults with atrial fibrillation or atrial flutter.

The 2020 Update to the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults With Atrial Fibrillation or Atrial Flutter was published online Dec. 7 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes. It was developed in collaboration with the Heart Rhythm Society.

Both performance measure changes were prompted by, and are in accordance with, the 2019 ACC/AHA/Heart Rhythm Society atrial fibrillation guideline focused update issued in January 2019, and reported by this news organization at that time.

The first change is the clarification that valvular atrial fibrillation is atrial fibrillation with either moderate or severe mitral stenosis or a mechanical heart valve. This change is incorporated into all the performance measures.

The second change, which only applies to the performance measure of anticoagulation prescribed, is the separation of a male and female threshold for the CHA₂DS₂-VASc score.

This threshold is now a score higher than 1 for men and higher than 2 for women, further demonstrating that the risk for stroke differs for men and women with atrial fibrillation or atrial flutter, the ACC/AHA noted in a press release.

“Successful implementation of these updated performance measures by clinicians and healthcare organizations will lead to quality improvement for adult patients with atrial fibrillation or atrial flutter,” they said.

A version of this article originally appeared on Medscape.com.

The American College of Cardiology and American Heart Association Task Force on Performance Measures have made two changes to performance measures for adults with atrial fibrillation or atrial flutter.

The 2020 Update to the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults With Atrial Fibrillation or Atrial Flutter was published online Dec. 7 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes. It was developed in collaboration with the Heart Rhythm Society.

Both performance measure changes were prompted by, and are in accordance with, the 2019 ACC/AHA/Heart Rhythm Society atrial fibrillation guideline focused update issued in January 2019, and reported by this news organization at that time.

The first change is the clarification that valvular atrial fibrillation is atrial fibrillation with either moderate or severe mitral stenosis or a mechanical heart valve. This change is incorporated into all the performance measures.

The second change, which only applies to the performance measure of anticoagulation prescribed, is the separation of a male and female threshold for the CHA₂DS₂-VASc score.

This threshold is now a score higher than 1 for men and higher than 2 for women, further demonstrating that the risk for stroke differs for men and women with atrial fibrillation or atrial flutter, the ACC/AHA noted in a press release.

“Successful implementation of these updated performance measures by clinicians and healthcare organizations will lead to quality improvement for adult patients with atrial fibrillation or atrial flutter,” they said.

A version of this article originally appeared on Medscape.com.

The American College of Cardiology and American Heart Association Task Force on Performance Measures have made two changes to performance measures for adults with atrial fibrillation or atrial flutter.

The 2020 Update to the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults With Atrial Fibrillation or Atrial Flutter was published online Dec. 7 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes. It was developed in collaboration with the Heart Rhythm Society.

Both performance measure changes were prompted by, and are in accordance with, the 2019 ACC/AHA/Heart Rhythm Society atrial fibrillation guideline focused update issued in January 2019, and reported by this news organization at that time.

The first change is the clarification that valvular atrial fibrillation is atrial fibrillation with either moderate or severe mitral stenosis or a mechanical heart valve. This change is incorporated into all the performance measures.

The second change, which only applies to the performance measure of anticoagulation prescribed, is the separation of a male and female threshold for the CHA₂DS₂-VASc score.

This threshold is now a score higher than 1 for men and higher than 2 for women, further demonstrating that the risk for stroke differs for men and women with atrial fibrillation or atrial flutter, the ACC/AHA noted in a press release.

“Successful implementation of these updated performance measures by clinicians and healthcare organizations will lead to quality improvement for adult patients with atrial fibrillation or atrial flutter,” they said.

A version of this article originally appeared on Medscape.com.

There has been a sharp increase in overdose-related cardiac arrests in the United States during the COVID-19 pandemic, a new analysis shows.

Overall rates in 2020 were elevated above the baseline from 2018 and 2019 by about 50%, the data show.

“Our results suggest that overdoses may be strongly on the rise in 2020, and efforts to combat the COVID-19 pandemic have not been effective at reducing overdoses,” Joseph Friedman, MPH, MD/PhD student, medical scientist training program, University of California, Los Angeles, said in an interview.

“We need to invest heavily in substance use treatment, harm reduction, and the structural drivers of overdose as core elements of the COVID-19 response,” said Mr. Friedman, who coauthored the study with UCLA colleague David Schriger, MD, MPH, and Leo Beletsky, JD, MPH, Northeastern University, Boston.

The study was published as a research letter Dec. 3 in JAMA Psychiatry.
 

Social isolation a key driver

Emergency medical services (EMS) data are available in near real time, providing a novel source of up-to-date information to monitor epidemiological shifts during the COVID-19 pandemic.

For the study, the researchers leveraged data from the National EMS Information System, a large registry of more than 10,000 EMS agencies in 47 states that represent over 80% of all EMS calls nationally in 2020. They used the data to track shifts in overdose-related cardiac arrests observed by EMS.

They found clear evidence of a large-scale uptick in overdose-related deaths during the COVID-19 pandemic.

The overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends observed during 2018 and 2019, including a maximum peak of 123% above baseline reached in early May.

All overdose-related incidents (fatal and nonfatal) were elevated in 2020, by about 17% above baseline. However, there were larger increases in fatal overdose-related incidents, compared to all incidents, which may suggest a rising case fatality rate, the authors noted.

The observed trends line up in time with reductions in mobility (a metric of social interaction), as measured using cell phone data, they wrote.

“Many of the trends predicted by experts at the beginning of the pandemic could cause these shifts. Increases in social isolation likely play an important role, as people using [drugs] alone are less likely to receive help when they need it. Also shifts in the drug supply, and reduced access to healthcare and treatment,” said Mr. Friedman.

“We need to undertake short- and long-term strategies to combat the rising tide of overdose mortality in the United States,” he added.

In the short term, Mr. Friedman suggested reducing financial and logistical barriers for accessing a safe opioid supply. Such measures include allowing pharmacies to dispense methadone, allowing all physicians to prescribe buprenorphine without a special waiver, and releasing emergency funds to make these medications universally affordable.

“In the longer term, we should acknowledge that overdose is a symptom of structural problems in the U.S. We need to invest in making employment, housing, education, and health care accessible to all to address the upstream drivers of overdose,” he added.

The study had no commercial funding. The authors disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

There has been a sharp increase in overdose-related cardiac arrests in the United States during the COVID-19 pandemic, a new analysis shows.

Overall rates in 2020 were elevated above the baseline from 2018 and 2019 by about 50%, the data show.

“Our results suggest that overdoses may be strongly on the rise in 2020, and efforts to combat the COVID-19 pandemic have not been effective at reducing overdoses,” Joseph Friedman, MPH, MD/PhD student, medical scientist training program, University of California, Los Angeles, said in an interview.

“We need to invest heavily in substance use treatment, harm reduction, and the structural drivers of overdose as core elements of the COVID-19 response,” said Mr. Friedman, who coauthored the study with UCLA colleague David Schriger, MD, MPH, and Leo Beletsky, JD, MPH, Northeastern University, Boston.

The study was published as a research letter Dec. 3 in JAMA Psychiatry.
 

Social isolation a key driver

Emergency medical services (EMS) data are available in near real time, providing a novel source of up-to-date information to monitor epidemiological shifts during the COVID-19 pandemic.

For the study, the researchers leveraged data from the National EMS Information System, a large registry of more than 10,000 EMS agencies in 47 states that represent over 80% of all EMS calls nationally in 2020. They used the data to track shifts in overdose-related cardiac arrests observed by EMS.

They found clear evidence of a large-scale uptick in overdose-related deaths during the COVID-19 pandemic.

The overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends observed during 2018 and 2019, including a maximum peak of 123% above baseline reached in early May.

All overdose-related incidents (fatal and nonfatal) were elevated in 2020, by about 17% above baseline. However, there were larger increases in fatal overdose-related incidents, compared to all incidents, which may suggest a rising case fatality rate, the authors noted.

The observed trends line up in time with reductions in mobility (a metric of social interaction), as measured using cell phone data, they wrote.

“Many of the trends predicted by experts at the beginning of the pandemic could cause these shifts. Increases in social isolation likely play an important role, as people using [drugs] alone are less likely to receive help when they need it. Also shifts in the drug supply, and reduced access to healthcare and treatment,” said Mr. Friedman.

“We need to undertake short- and long-term strategies to combat the rising tide of overdose mortality in the United States,” he added.

In the short term, Mr. Friedman suggested reducing financial and logistical barriers for accessing a safe opioid supply. Such measures include allowing pharmacies to dispense methadone, allowing all physicians to prescribe buprenorphine without a special waiver, and releasing emergency funds to make these medications universally affordable.

“In the longer term, we should acknowledge that overdose is a symptom of structural problems in the U.S. We need to invest in making employment, housing, education, and health care accessible to all to address the upstream drivers of overdose,” he added.

The study had no commercial funding. The authors disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

There has been a sharp increase in overdose-related cardiac arrests in the United States during the COVID-19 pandemic, a new analysis shows.

Overall rates in 2020 were elevated above the baseline from 2018 and 2019 by about 50%, the data show.

“Our results suggest that overdoses may be strongly on the rise in 2020, and efforts to combat the COVID-19 pandemic have not been effective at reducing overdoses,” Joseph Friedman, MPH, MD/PhD student, medical scientist training program, University of California, Los Angeles, said in an interview.

“We need to invest heavily in substance use treatment, harm reduction, and the structural drivers of overdose as core elements of the COVID-19 response,” said Mr. Friedman, who coauthored the study with UCLA colleague David Schriger, MD, MPH, and Leo Beletsky, JD, MPH, Northeastern University, Boston.

The study was published as a research letter Dec. 3 in JAMA Psychiatry.
 

Social isolation a key driver

Emergency medical services (EMS) data are available in near real time, providing a novel source of up-to-date information to monitor epidemiological shifts during the COVID-19 pandemic.

For the study, the researchers leveraged data from the National EMS Information System, a large registry of more than 10,000 EMS agencies in 47 states that represent over 80% of all EMS calls nationally in 2020. They used the data to track shifts in overdose-related cardiac arrests observed by EMS.

They found clear evidence of a large-scale uptick in overdose-related deaths during the COVID-19 pandemic.

The overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends observed during 2018 and 2019, including a maximum peak of 123% above baseline reached in early May.

All overdose-related incidents (fatal and nonfatal) were elevated in 2020, by about 17% above baseline. However, there were larger increases in fatal overdose-related incidents, compared to all incidents, which may suggest a rising case fatality rate, the authors noted.

The observed trends line up in time with reductions in mobility (a metric of social interaction), as measured using cell phone data, they wrote.

“Many of the trends predicted by experts at the beginning of the pandemic could cause these shifts. Increases in social isolation likely play an important role, as people using [drugs] alone are less likely to receive help when they need it. Also shifts in the drug supply, and reduced access to healthcare and treatment,” said Mr. Friedman.

“We need to undertake short- and long-term strategies to combat the rising tide of overdose mortality in the United States,” he added.

In the short term, Mr. Friedman suggested reducing financial and logistical barriers for accessing a safe opioid supply. Such measures include allowing pharmacies to dispense methadone, allowing all physicians to prescribe buprenorphine without a special waiver, and releasing emergency funds to make these medications universally affordable.

“In the longer term, we should acknowledge that overdose is a symptom of structural problems in the U.S. We need to invest in making employment, housing, education, and health care accessible to all to address the upstream drivers of overdose,” he added.

The study had no commercial funding. The authors disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

There is “compelling” evidence of the harmful effects of alcohol on the brain. The greatest risk occurs during three periods of life that are marked by dynamic brain changes, say researchers from Australia and the United Kingdom.

alenkadr/Thinkstock

The three periods are:

• Gestation (conception to birth), which is characterized by extensive production, migration, and differentiation of neurons, as well as substantial apoptosis.
• Later adolescence (aged 15-19 years), a period marked by synaptic pruning and increased axonal myelination.
• Older adulthood (aged 65 and beyond), a period associated with brain atrophy. Changes accelerate after age 65, largely driven by decreases in neuron size and reductions in the number of dendritic spines and synapses.

These changes in neurocircuitry could increase sensitivity to the neurotoxic effects of alcohol, Louise Mewton, PhD, of the Center for Healthy Brain Aging, University of New South Wales, Sydney, and colleagues said.

“A life course perspective on brain health supports the formulation of policy and public health interventions to reduce alcohol use and misuse at all ages,” they wrote in an editorial published online Dec. 4 in The BMJ.
 

Worrisome trends

Research has shown that globally about 10% of pregnant women drink alcohol. In European countries, the rates are much higher than the global average.

Heavy drinking during gestation can cause fetal alcohol spectrum disorder, which is associated with widespread reductions in brain volume and cognitive impairment.

Even low or moderate alcohol consumption during pregnancy is significantly associated with poorer psychological and behavioral outcomes in children, the investigators noted.

In adolescence, more than 20% of 15- to 19-year-olds in European and other high-income countries report at least occasional binge drinking, which is linked to reduced brain volume, poorer white matter development, and deficits in a range of cognitive functions, they added.

In a recent study of older adults, alcohol use disorders emerged as one of the strongest modifiable risk factors for dementia (particularly early-onset dementia), compared with other established risk factors such as high blood pressure and smoking.

Alcohol use disorders are relatively rare in older adults, but even moderate drinking during midlife has been linked to “small but significant” brain volume loss, the authors said.

Dr. Mewton and colleagues said demographic trends may compound the effect of alcohol use on brain health.

They noted that women are now just as likely as men to drink alcohol and suffer alcohol-related problems. Global consumption is forecast to increase further in the next decade.

Although the effects of the COVID-19 pandemic on alcohol intake and related harms remain unclear, alcohol use has increased in the long term after other major public health crises, they added.

Given the data, Dr. Mewton and colleagues called for “an integrated approach” to reducing the harms of alcohol intake at all ages.

“Population-based interventions such as guidelines on low-risk drinking, alcohol pricing policies, and lower drink driving limits need to be accompanied by the development of training and care pathways that consider the human brain at risk throughout life,” they concluded.

The authors have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

There is “compelling” evidence of the harmful effects of alcohol on the brain. The greatest risk occurs during three periods of life that are marked by dynamic brain changes, say researchers from Australia and the United Kingdom.

alenkadr/Thinkstock

The three periods are:

• Gestation (conception to birth), which is characterized by extensive production, migration, and differentiation of neurons, as well as substantial apoptosis.
• Later adolescence (aged 15-19 years), a period marked by synaptic pruning and increased axonal myelination.
• Older adulthood (aged 65 and beyond), a period associated with brain atrophy. Changes accelerate after age 65, largely driven by decreases in neuron size and reductions in the number of dendritic spines and synapses.

These changes in neurocircuitry could increase sensitivity to the neurotoxic effects of alcohol, Louise Mewton, PhD, of the Center for Healthy Brain Aging, University of New South Wales, Sydney, and colleagues said.

“A life course perspective on brain health supports the formulation of policy and public health interventions to reduce alcohol use and misuse at all ages,” they wrote in an editorial published online Dec. 4 in The BMJ.
 

Worrisome trends

Research has shown that globally about 10% of pregnant women drink alcohol. In European countries, the rates are much higher than the global average.

Heavy drinking during gestation can cause fetal alcohol spectrum disorder, which is associated with widespread reductions in brain volume and cognitive impairment.

Even low or moderate alcohol consumption during pregnancy is significantly associated with poorer psychological and behavioral outcomes in children, the investigators noted.

In adolescence, more than 20% of 15- to 19-year-olds in European and other high-income countries report at least occasional binge drinking, which is linked to reduced brain volume, poorer white matter development, and deficits in a range of cognitive functions, they added.

In a recent study of older adults, alcohol use disorders emerged as one of the strongest modifiable risk factors for dementia (particularly early-onset dementia), compared with other established risk factors such as high blood pressure and smoking.

Alcohol use disorders are relatively rare in older adults, but even moderate drinking during midlife has been linked to “small but significant” brain volume loss, the authors said.

Dr. Mewton and colleagues said demographic trends may compound the effect of alcohol use on brain health.

They noted that women are now just as likely as men to drink alcohol and suffer alcohol-related problems. Global consumption is forecast to increase further in the next decade.

Although the effects of the COVID-19 pandemic on alcohol intake and related harms remain unclear, alcohol use has increased in the long term after other major public health crises, they added.

Given the data, Dr. Mewton and colleagues called for “an integrated approach” to reducing the harms of alcohol intake at all ages.

“Population-based interventions such as guidelines on low-risk drinking, alcohol pricing policies, and lower drink driving limits need to be accompanied by the development of training and care pathways that consider the human brain at risk throughout life,” they concluded.

The authors have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

There is “compelling” evidence of the harmful effects of alcohol on the brain. The greatest risk occurs during three periods of life that are marked by dynamic brain changes, say researchers from Australia and the United Kingdom.

alenkadr/Thinkstock

The three periods are:

• Gestation (conception to birth), which is characterized by extensive production, migration, and differentiation of neurons, as well as substantial apoptosis.
• Later adolescence (aged 15-19 years), a period marked by synaptic pruning and increased axonal myelination.
• Older adulthood (aged 65 and beyond), a period associated with brain atrophy. Changes accelerate after age 65, largely driven by decreases in neuron size and reductions in the number of dendritic spines and synapses.

These changes in neurocircuitry could increase sensitivity to the neurotoxic effects of alcohol, Louise Mewton, PhD, of the Center for Healthy Brain Aging, University of New South Wales, Sydney, and colleagues said.

“A life course perspective on brain health supports the formulation of policy and public health interventions to reduce alcohol use and misuse at all ages,” they wrote in an editorial published online Dec. 4 in The BMJ.
 

Worrisome trends

Research has shown that globally about 10% of pregnant women drink alcohol. In European countries, the rates are much higher than the global average.

Heavy drinking during gestation can cause fetal alcohol spectrum disorder, which is associated with widespread reductions in brain volume and cognitive impairment.

Even low or moderate alcohol consumption during pregnancy is significantly associated with poorer psychological and behavioral outcomes in children, the investigators noted.

In adolescence, more than 20% of 15- to 19-year-olds in European and other high-income countries report at least occasional binge drinking, which is linked to reduced brain volume, poorer white matter development, and deficits in a range of cognitive functions, they added.

In a recent study of older adults, alcohol use disorders emerged as one of the strongest modifiable risk factors for dementia (particularly early-onset dementia), compared with other established risk factors such as high blood pressure and smoking.

Alcohol use disorders are relatively rare in older adults, but even moderate drinking during midlife has been linked to “small but significant” brain volume loss, the authors said.

Dr. Mewton and colleagues said demographic trends may compound the effect of alcohol use on brain health.

They noted that women are now just as likely as men to drink alcohol and suffer alcohol-related problems. Global consumption is forecast to increase further in the next decade.

Although the effects of the COVID-19 pandemic on alcohol intake and related harms remain unclear, alcohol use has increased in the long term after other major public health crises, they added.

Given the data, Dr. Mewton and colleagues called for “an integrated approach” to reducing the harms of alcohol intake at all ages.

“Population-based interventions such as guidelines on low-risk drinking, alcohol pricing policies, and lower drink driving limits need to be accompanied by the development of training and care pathways that consider the human brain at risk throughout life,” they concluded.

The authors have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Cases of poisoning – intentional and unintentional – from ingestion of alcohol-based hand sanitizer have soared during the COVID-19 pandemic.

In the United Kingdom alone, alcohol-based hand sanitizer poisonings reported to the National Poisons Information Service jumped 157% – from 155 between January 1 and September 16, 2019, to 398 between Jan. 1 and Sept. 14, 2020, new research shows.

More needs to be done to protect those at risk of unintentional and intentional swallowing of alcohol-based hand sanitizer, including children, people with dementia/confusion, and those with mental health issues, according to Georgia Richards, DPhil student, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford (England).

“If providers are supplying alcohol-based hand sanitizers in the community to reduce the spread of SARS-CoV-2, the contents should be supplied in lockable and automated dispensers to reduce contamination and improve safety,” Ms. Richards said in an interview.

The study was published online Dec. 1 in BMJ Evidence-Based Medicine.
 

European, U.S. poisoning rates soar

In the paper Ms. Richards described two deaths that occurred in hospitals in England.

In one case, a 30-year-old woman, detained in a psychiatric unit who received the antidepressant venlafaxine was found dead in her hospital bed with a container of hand-sanitizing gel beside her.

“The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers with it to keep in their rooms,” Ms. Richards reported.

A postmortem analysis found a high level of alcohol in her blood (214 mg of alcohol in 100 mL of blood). The medical cause of death was listed as “ingestion of alcohol and venlafaxine.” The coroner concluded that the combination of these substances suppressed the patient’s breathing, leading to her death.

The other case involved a 76-year-old man who unintentionally swallowed an unknown quantity of alcohol-based hand-sanitizing foam attached to the foot of his hospital bed.

The patient had a history of agitation and depression and was treated with antidepressants. He had become increasingly confused over the preceding 9 months, possibly because of vascular dementia.

His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77mmol/L) 10 hours later. He was admitted to the ICU, where he received lorazepam and haloperidol and treated with ventilation, with a plan to allow the alcohol to be naturally metabolized.

The patient developed complications and died 6 days later. The primary causes of death were bronchopneumonia and acute alcohol toxicity, secondary to acute delirium and coronary artery disease.

Since COVID-19 started, alcohol-based hand sanitizers are among the most sought-after commodities around the world. The volume of these products – now found in homes, hospitals, schools, workplaces, and elsewhere – “may be a cause for concern,” Ms. Richards wrote.

Yet, warnings about the toxicity and lethality of intentional or unintentional ingestion of these products have not been widely disseminated, she noted.

To reduce the risk of harm, Ms. Richards suggested educating the public and health care professionals, improving warning labels on products, and increasing the awareness and reporting of such exposures to public health authorities.

“While governments and public health authorities have successfully heightened our awareness of, and need for, better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centers,” she noted.

Increases in alcohol-based hand sanitizer poisoning during the pandemic have also been reported in the United States.

The American Association of Poison Control Centers reports that data from the National Poison Data System show 32,892 hand sanitizer exposure cases reported to the 55 U.S. poison control centers from Jan. 1 to Nov. 15, 2020 – an increase of 73%, compared with the same time period during the previous year.
 

An increase in self-harm

Weighing in on this issue, Robert Bassett, DO, associate medical director of the Poison Control Center at Children’s Hospital of Philadelphia, said in an interview that “cleaning agents and disinfectants have been around for eons and their potential for toxicity hasn’t changed.

“Now with COVID, and this hypervigilance when it comes to cleanliness, there is increased access and the exposure risk has gone up,” he said.

“One of the sad casualties of an overstressed health care system and a globally depressed environment is worsening behavioral health emergencies and, as part of that, the risk of self-harm goes up,” Dr. Bassett added.

“The consensus is that there has been an exacerbation of behavioral health emergencies and behavioral health needs since COVID started and hand sanitizers are readily accessible to someone who may be looking to self-harm,” he said.

This research had no specific funding. Ms. Richards is the editorial registrar of BMJ Evidence Based Medicine and is developing a website to track preventable deaths. Dr. Bassett disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Cases of poisoning – intentional and unintentional – from ingestion of alcohol-based hand sanitizer have soared during the COVID-19 pandemic.

In the United Kingdom alone, alcohol-based hand sanitizer poisonings reported to the National Poisons Information Service jumped 157% – from 155 between January 1 and September 16, 2019, to 398 between Jan. 1 and Sept. 14, 2020, new research shows.

More needs to be done to protect those at risk of unintentional and intentional swallowing of alcohol-based hand sanitizer, including children, people with dementia/confusion, and those with mental health issues, according to Georgia Richards, DPhil student, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford (England).

“If providers are supplying alcohol-based hand sanitizers in the community to reduce the spread of SARS-CoV-2, the contents should be supplied in lockable and automated dispensers to reduce contamination and improve safety,” Ms. Richards said in an interview.

The study was published online Dec. 1 in BMJ Evidence-Based Medicine.
 

European, U.S. poisoning rates soar

In the paper Ms. Richards described two deaths that occurred in hospitals in England.

In one case, a 30-year-old woman, detained in a psychiatric unit who received the antidepressant venlafaxine was found dead in her hospital bed with a container of hand-sanitizing gel beside her.

“The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers with it to keep in their rooms,” Ms. Richards reported.

A postmortem analysis found a high level of alcohol in her blood (214 mg of alcohol in 100 mL of blood). The medical cause of death was listed as “ingestion of alcohol and venlafaxine.” The coroner concluded that the combination of these substances suppressed the patient’s breathing, leading to her death.

The other case involved a 76-year-old man who unintentionally swallowed an unknown quantity of alcohol-based hand-sanitizing foam attached to the foot of his hospital bed.

The patient had a history of agitation and depression and was treated with antidepressants. He had become increasingly confused over the preceding 9 months, possibly because of vascular dementia.

His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77mmol/L) 10 hours later. He was admitted to the ICU, where he received lorazepam and haloperidol and treated with ventilation, with a plan to allow the alcohol to be naturally metabolized.

The patient developed complications and died 6 days later. The primary causes of death were bronchopneumonia and acute alcohol toxicity, secondary to acute delirium and coronary artery disease.

Since COVID-19 started, alcohol-based hand sanitizers are among the most sought-after commodities around the world. The volume of these products – now found in homes, hospitals, schools, workplaces, and elsewhere – “may be a cause for concern,” Ms. Richards wrote.

Yet, warnings about the toxicity and lethality of intentional or unintentional ingestion of these products have not been widely disseminated, she noted.

To reduce the risk of harm, Ms. Richards suggested educating the public and health care professionals, improving warning labels on products, and increasing the awareness and reporting of such exposures to public health authorities.

“While governments and public health authorities have successfully heightened our awareness of, and need for, better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centers,” she noted.

Increases in alcohol-based hand sanitizer poisoning during the pandemic have also been reported in the United States.

The American Association of Poison Control Centers reports that data from the National Poison Data System show 32,892 hand sanitizer exposure cases reported to the 55 U.S. poison control centers from Jan. 1 to Nov. 15, 2020 – an increase of 73%, compared with the same time period during the previous year.
 

An increase in self-harm

Weighing in on this issue, Robert Bassett, DO, associate medical director of the Poison Control Center at Children’s Hospital of Philadelphia, said in an interview that “cleaning agents and disinfectants have been around for eons and their potential for toxicity hasn’t changed.

“Now with COVID, and this hypervigilance when it comes to cleanliness, there is increased access and the exposure risk has gone up,” he said.

“One of the sad casualties of an overstressed health care system and a globally depressed environment is worsening behavioral health emergencies and, as part of that, the risk of self-harm goes up,” Dr. Bassett added.

“The consensus is that there has been an exacerbation of behavioral health emergencies and behavioral health needs since COVID started and hand sanitizers are readily accessible to someone who may be looking to self-harm,” he said.

This research had no specific funding. Ms. Richards is the editorial registrar of BMJ Evidence Based Medicine and is developing a website to track preventable deaths. Dr. Bassett disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Cases of poisoning – intentional and unintentional – from ingestion of alcohol-based hand sanitizer have soared during the COVID-19 pandemic.

In the United Kingdom alone, alcohol-based hand sanitizer poisonings reported to the National Poisons Information Service jumped 157% – from 155 between January 1 and September 16, 2019, to 398 between Jan. 1 and Sept. 14, 2020, new research shows.

More needs to be done to protect those at risk of unintentional and intentional swallowing of alcohol-based hand sanitizer, including children, people with dementia/confusion, and those with mental health issues, according to Georgia Richards, DPhil student, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford (England).

“If providers are supplying alcohol-based hand sanitizers in the community to reduce the spread of SARS-CoV-2, the contents should be supplied in lockable and automated dispensers to reduce contamination and improve safety,” Ms. Richards said in an interview.

The study was published online Dec. 1 in BMJ Evidence-Based Medicine.
 

European, U.S. poisoning rates soar

In the paper Ms. Richards described two deaths that occurred in hospitals in England.

In one case, a 30-year-old woman, detained in a psychiatric unit who received the antidepressant venlafaxine was found dead in her hospital bed with a container of hand-sanitizing gel beside her.

“The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers with it to keep in their rooms,” Ms. Richards reported.

A postmortem analysis found a high level of alcohol in her blood (214 mg of alcohol in 100 mL of blood). The medical cause of death was listed as “ingestion of alcohol and venlafaxine.” The coroner concluded that the combination of these substances suppressed the patient’s breathing, leading to her death.

The other case involved a 76-year-old man who unintentionally swallowed an unknown quantity of alcohol-based hand-sanitizing foam attached to the foot of his hospital bed.

The patient had a history of agitation and depression and was treated with antidepressants. He had become increasingly confused over the preceding 9 months, possibly because of vascular dementia.

His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77mmol/L) 10 hours later. He was admitted to the ICU, where he received lorazepam and haloperidol and treated with ventilation, with a plan to allow the alcohol to be naturally metabolized.

The patient developed complications and died 6 days later. The primary causes of death were bronchopneumonia and acute alcohol toxicity, secondary to acute delirium and coronary artery disease.

Since COVID-19 started, alcohol-based hand sanitizers are among the most sought-after commodities around the world. The volume of these products – now found in homes, hospitals, schools, workplaces, and elsewhere – “may be a cause for concern,” Ms. Richards wrote.

Yet, warnings about the toxicity and lethality of intentional or unintentional ingestion of these products have not been widely disseminated, she noted.

To reduce the risk of harm, Ms. Richards suggested educating the public and health care professionals, improving warning labels on products, and increasing the awareness and reporting of such exposures to public health authorities.

“While governments and public health authorities have successfully heightened our awareness of, and need for, better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centers,” she noted.

Increases in alcohol-based hand sanitizer poisoning during the pandemic have also been reported in the United States.

The American Association of Poison Control Centers reports that data from the National Poison Data System show 32,892 hand sanitizer exposure cases reported to the 55 U.S. poison control centers from Jan. 1 to Nov. 15, 2020 – an increase of 73%, compared with the same time period during the previous year.
 

An increase in self-harm

Weighing in on this issue, Robert Bassett, DO, associate medical director of the Poison Control Center at Children’s Hospital of Philadelphia, said in an interview that “cleaning agents and disinfectants have been around for eons and their potential for toxicity hasn’t changed.

“Now with COVID, and this hypervigilance when it comes to cleanliness, there is increased access and the exposure risk has gone up,” he said.

“One of the sad casualties of an overstressed health care system and a globally depressed environment is worsening behavioral health emergencies and, as part of that, the risk of self-harm goes up,” Dr. Bassett added.

“The consensus is that there has been an exacerbation of behavioral health emergencies and behavioral health needs since COVID started and hand sanitizers are readily accessible to someone who may be looking to self-harm,” he said.

This research had no specific funding. Ms. Richards is the editorial registrar of BMJ Evidence Based Medicine and is developing a website to track preventable deaths. Dr. Bassett disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.

Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia). 

Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.

“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.

“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.

David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”

Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.

In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.

Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.

Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.

The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.

The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.

The company expects the drug to be commercially available in the United States in the first quarter of 2021.

Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.

The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.

Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia). 

Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.

“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.

“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.

David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”

Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.

In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.

Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.

Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.

The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.

The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.

The company expects the drug to be commercially available in the United States in the first quarter of 2021.

Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.

The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.

Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia). 

Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.

“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.

“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.

David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”

Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.

In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.

Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.

Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.

The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.

The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.

The company expects the drug to be commercially available in the United States in the first quarter of 2021.

Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.

The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.

A version of this article originally appeared on Medscape.com.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.