Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.

FDA warns of possible cancer risk with lorcaserin

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Tue, 05/03/2022 - 15:11

The Food and Drug Administration has issued a Safety Alert regarding the weight-management medication lorcaserin (Belviq, Belviq XR) after results from a clinical trial assessing the drug’s safety showed a possible increased risk of cancer.

bankrx/Getty Images

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk,” the agency said in a press release.

The agency advised that health care providers consider whether the benefits of taking lorcaserin outweighed the potential cancer risk, and that patients currently taking the medication should talk to their providers about the risks.

“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA noted in the statement.

Lorcaserin, a serotonin 2C receptor agonist, was approved by the FDA in 2012 at a dosage of 20 mg once daily for use with a reduced-calorie diet and increased physical activity as a means to improve weight loss in adults who are obese or overweight and have at least one weight-related medical problem, such as such as hypertension, type 2 diabetes, or dyslipidemia. In July 2016, the agency approved a New Drug Application for an extended-release, once-daily formulation.

Headache, dizziness, fatigue, nausea, dry mouth, and constipation are the more common adverse effects in patients without diabetes, whereas hypoglycemia, headache, back pain, cough, and fatigue are more common in patients with diabetes. The treatment is contraindicated for pregnancy.

Lorcaserin is distributed by Eisai.*

[email protected]

*Correction, 1/15/2020: An earlier version of this story misstated the manufacturer of lorcaserin. 

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The Food and Drug Administration has issued a Safety Alert regarding the weight-management medication lorcaserin (Belviq, Belviq XR) after results from a clinical trial assessing the drug’s safety showed a possible increased risk of cancer.

bankrx/Getty Images

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk,” the agency said in a press release.

The agency advised that health care providers consider whether the benefits of taking lorcaserin outweighed the potential cancer risk, and that patients currently taking the medication should talk to their providers about the risks.

“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA noted in the statement.

Lorcaserin, a serotonin 2C receptor agonist, was approved by the FDA in 2012 at a dosage of 20 mg once daily for use with a reduced-calorie diet and increased physical activity as a means to improve weight loss in adults who are obese or overweight and have at least one weight-related medical problem, such as such as hypertension, type 2 diabetes, or dyslipidemia. In July 2016, the agency approved a New Drug Application for an extended-release, once-daily formulation.

Headache, dizziness, fatigue, nausea, dry mouth, and constipation are the more common adverse effects in patients without diabetes, whereas hypoglycemia, headache, back pain, cough, and fatigue are more common in patients with diabetes. The treatment is contraindicated for pregnancy.

Lorcaserin is distributed by Eisai.*

[email protected]

*Correction, 1/15/2020: An earlier version of this story misstated the manufacturer of lorcaserin. 

The Food and Drug Administration has issued a Safety Alert regarding the weight-management medication lorcaserin (Belviq, Belviq XR) after results from a clinical trial assessing the drug’s safety showed a possible increased risk of cancer.

bankrx/Getty Images

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk,” the agency said in a press release.

The agency advised that health care providers consider whether the benefits of taking lorcaserin outweighed the potential cancer risk, and that patients currently taking the medication should talk to their providers about the risks.

“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA noted in the statement.

Lorcaserin, a serotonin 2C receptor agonist, was approved by the FDA in 2012 at a dosage of 20 mg once daily for use with a reduced-calorie diet and increased physical activity as a means to improve weight loss in adults who are obese or overweight and have at least one weight-related medical problem, such as such as hypertension, type 2 diabetes, or dyslipidemia. In July 2016, the agency approved a New Drug Application for an extended-release, once-daily formulation.

Headache, dizziness, fatigue, nausea, dry mouth, and constipation are the more common adverse effects in patients without diabetes, whereas hypoglycemia, headache, back pain, cough, and fatigue are more common in patients with diabetes. The treatment is contraindicated for pregnancy.

Lorcaserin is distributed by Eisai.*

[email protected]

*Correction, 1/15/2020: An earlier version of this story misstated the manufacturer of lorcaserin. 

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FDA approves avapritinib for adults with GIST with PDGFRA mutation

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Wed, 05/26/2021 - 13:46

The Food and Drug Administration has approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) with a platelet-derived growth factor receptor–alpha (PDGFRA) exon 18 mutation.

Olivier Le Moal/Getty Images

Approval was based on results from a clinical trial of 43 patients with PDGFRA exon 18 mutations, including 38 patients with a PDGFRA D842V mutation, who received 300 mg avapritinib once daily, the FDA said in a statement.

The overall response rate was 84% (7% with complete response, 77% with partial response); the response rate in patients with a D842V mutation was 89% (8% with complete response, 82% with partial response). Median response duration was not reached, but 61% of patients had a response lasting longer than 6 months.

The most common adverse events associated with avapritinib include edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness. The drug also can cause intracranial hemorrhage and have effects on the central nervous system.

“GIST harboring a PDGFRA exon 18 mutation do not respond to standard therapies for GIST. However, today’s approval provides patients with the first drug specifically approved for GIST harboring this mutation,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research, said in the statement.

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The Food and Drug Administration has approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) with a platelet-derived growth factor receptor–alpha (PDGFRA) exon 18 mutation.

Olivier Le Moal/Getty Images

Approval was based on results from a clinical trial of 43 patients with PDGFRA exon 18 mutations, including 38 patients with a PDGFRA D842V mutation, who received 300 mg avapritinib once daily, the FDA said in a statement.

The overall response rate was 84% (7% with complete response, 77% with partial response); the response rate in patients with a D842V mutation was 89% (8% with complete response, 82% with partial response). Median response duration was not reached, but 61% of patients had a response lasting longer than 6 months.

The most common adverse events associated with avapritinib include edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness. The drug also can cause intracranial hemorrhage and have effects on the central nervous system.

“GIST harboring a PDGFRA exon 18 mutation do not respond to standard therapies for GIST. However, today’s approval provides patients with the first drug specifically approved for GIST harboring this mutation,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research, said in the statement.

The Food and Drug Administration has approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) with a platelet-derived growth factor receptor–alpha (PDGFRA) exon 18 mutation.

Olivier Le Moal/Getty Images

Approval was based on results from a clinical trial of 43 patients with PDGFRA exon 18 mutations, including 38 patients with a PDGFRA D842V mutation, who received 300 mg avapritinib once daily, the FDA said in a statement.

The overall response rate was 84% (7% with complete response, 77% with partial response); the response rate in patients with a D842V mutation was 89% (8% with complete response, 82% with partial response). Median response duration was not reached, but 61% of patients had a response lasting longer than 6 months.

The most common adverse events associated with avapritinib include edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness. The drug also can cause intracranial hemorrhage and have effects on the central nervous system.

“GIST harboring a PDGFRA exon 18 mutation do not respond to standard therapies for GIST. However, today’s approval provides patients with the first drug specifically approved for GIST harboring this mutation,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research, said in the statement.

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Invasion of the body-snatcher DNA, and pediatric ‘La Niña’s revenge’

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Changed
Thu, 01/16/2020 - 12:21

 

A place for everything

Nerthuz/iStock/Getty Images Plus

Our editor – imagine a combination of Mitch McConnell and SpongeBob SquarePants – is a big fan of the year-in-review list and said we should do one. But he turned down our idea for “Top 10 reasons not to do a year-in-review list,” so we’re doing the next-best thing: reporting on someone else’s.

We came across a list on Vice.com that was right up our alley, so to speak: “What did we get stuck in our rectums last year?”

It’s the latest edition of an annual list compiled by Barry Petchesky, who says he’s “been chronicling our country’s cavity misadventures” for a decade using data from the U.S. Consumer Product Safety Commission’s National Electronic Injury Surveillance System (NEISS) database.

After you’re done here, we strongly urge you to check out Mr. Petchesky’s full list, which covers all of the major bodily orifices and is not limited to rectums. In the meantime, here are a few highlights, with quotes from the actual NEISS reports when necessary:

  • Christmas ornament (ear).
  • Egg timer (rectum).
  • “Jumped off couch landed on spoon” (vagina).
  • Christmas ornament (nose).
  • Small shampoo bottle (rectum).
  • Large shampoo bottle (rectum).
  • Christmas ornament (throat).
  • “Was using prostate massager & it got ‘sucked in’ ” (rectum).
  • Coaxial cable (penis).
  • Christmas ornament (rectum).

The weather stinks today

Pavliha/E+

On the surface, the El Niño–Southern Oscillation isn’t the most impressive phenomenon in the world. The tropical eastern Pacific Ocean isn’t a small area, but there’s a lot of ocean out there, and the temperature difference from the norm during El Niño and its less well-known sister, La Niña, is only a few degrees.

But that blob of water can have massive effects on the world’s climate, causing drought and heat waves in some areas while being responsible for increased storms and massive amounts of rainfall and diarrhea in others.

“Wait, hang on – what was that last one?” you’re probably asking.

Yes, we’re going from “things stuck in our rectums” to “things very much not stuck in our rectums” thanks to a study published in Nature Communications. According to the researchers from Columbia University, La Niña (cooler water) is linked to increased diarrhea in young children in Botswana. During La Niña years, incidence of diarrhea in children aged 5 years or younger is 30% higher than in non–La Niña years.

It does make sense when you think about it. In southern Africa, La Niña is associated with cooler weather, increased rainfall, and more flooding during the rainy season. The aftermath of extreme rainfall events is often a breeding ground for waterborne pathogens. And so the diarrhea flows.

So, if you happen to be reading this from Botswana, pay attention to the news. If the meteorologists start talking about La Niña, you may want to stock up on oral rehydration salts and zinc.
 

 

 

Are two DNAs better than one?

Jezperklauzen/ThinkStock

Before you read any further, you need to find the X-Files theme to set the mood, so use this link and get it started.

Okay, is it on? No? That’s fine, we can wait.

Now are you ready? Good, here goes.

What happens after you receive a bone marrow transplant to treat acute myeloid leukemia? Many years of life, hopefully. But what if you survived and then started to turn into someone else? What if the DNA from the bone marrow donor started to replace your DNA?

Now you know why we needed the X-Files music.

Chris Long, who works at the Washoe County (Nev.) Sheriff’s Department, underwent a bone marrow transplant several years ago. Just before the procedure, a friend and colleague in the department, who just happened to run the crime lab, asked him for DNA samples.

Say, isn’t Area 51 in Nevada? Hmm, interesting.

A few months later, the lab determined that all of the DNA in his blood had been replaced by that of the bone marrow donor, the New York Times reported. And over the years, “swabs collected from his lip, cheek and tongue showed that these also contained his donor’s DNA, with the percentages rising and falling.”

Even more surprising? After 4 years, Mr. Long’s colleagues in the crime lab found that all of the DNA in his semen belonged to the donor, the Times said.

Mr. Long, it seems, has become a chimera, a combination of two people.

Guess what? There was an X-Files episode called “Chimera.”

Now, we’re not saying that all this proves aliens were involved, but … well … you know.



 

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A place for everything

Nerthuz/iStock/Getty Images Plus

Our editor – imagine a combination of Mitch McConnell and SpongeBob SquarePants – is a big fan of the year-in-review list and said we should do one. But he turned down our idea for “Top 10 reasons not to do a year-in-review list,” so we’re doing the next-best thing: reporting on someone else’s.

We came across a list on Vice.com that was right up our alley, so to speak: “What did we get stuck in our rectums last year?”

It’s the latest edition of an annual list compiled by Barry Petchesky, who says he’s “been chronicling our country’s cavity misadventures” for a decade using data from the U.S. Consumer Product Safety Commission’s National Electronic Injury Surveillance System (NEISS) database.

After you’re done here, we strongly urge you to check out Mr. Petchesky’s full list, which covers all of the major bodily orifices and is not limited to rectums. In the meantime, here are a few highlights, with quotes from the actual NEISS reports when necessary:

  • Christmas ornament (ear).
  • Egg timer (rectum).
  • “Jumped off couch landed on spoon” (vagina).
  • Christmas ornament (nose).
  • Small shampoo bottle (rectum).
  • Large shampoo bottle (rectum).
  • Christmas ornament (throat).
  • “Was using prostate massager & it got ‘sucked in’ ” (rectum).
  • Coaxial cable (penis).
  • Christmas ornament (rectum).

The weather stinks today

Pavliha/E+

On the surface, the El Niño–Southern Oscillation isn’t the most impressive phenomenon in the world. The tropical eastern Pacific Ocean isn’t a small area, but there’s a lot of ocean out there, and the temperature difference from the norm during El Niño and its less well-known sister, La Niña, is only a few degrees.

But that blob of water can have massive effects on the world’s climate, causing drought and heat waves in some areas while being responsible for increased storms and massive amounts of rainfall and diarrhea in others.

“Wait, hang on – what was that last one?” you’re probably asking.

Yes, we’re going from “things stuck in our rectums” to “things very much not stuck in our rectums” thanks to a study published in Nature Communications. According to the researchers from Columbia University, La Niña (cooler water) is linked to increased diarrhea in young children in Botswana. During La Niña years, incidence of diarrhea in children aged 5 years or younger is 30% higher than in non–La Niña years.

It does make sense when you think about it. In southern Africa, La Niña is associated with cooler weather, increased rainfall, and more flooding during the rainy season. The aftermath of extreme rainfall events is often a breeding ground for waterborne pathogens. And so the diarrhea flows.

So, if you happen to be reading this from Botswana, pay attention to the news. If the meteorologists start talking about La Niña, you may want to stock up on oral rehydration salts and zinc.
 

 

 

Are two DNAs better than one?

Jezperklauzen/ThinkStock

Before you read any further, you need to find the X-Files theme to set the mood, so use this link and get it started.

Okay, is it on? No? That’s fine, we can wait.

Now are you ready? Good, here goes.

What happens after you receive a bone marrow transplant to treat acute myeloid leukemia? Many years of life, hopefully. But what if you survived and then started to turn into someone else? What if the DNA from the bone marrow donor started to replace your DNA?

Now you know why we needed the X-Files music.

Chris Long, who works at the Washoe County (Nev.) Sheriff’s Department, underwent a bone marrow transplant several years ago. Just before the procedure, a friend and colleague in the department, who just happened to run the crime lab, asked him for DNA samples.

Say, isn’t Area 51 in Nevada? Hmm, interesting.

A few months later, the lab determined that all of the DNA in his blood had been replaced by that of the bone marrow donor, the New York Times reported. And over the years, “swabs collected from his lip, cheek and tongue showed that these also contained his donor’s DNA, with the percentages rising and falling.”

Even more surprising? After 4 years, Mr. Long’s colleagues in the crime lab found that all of the DNA in his semen belonged to the donor, the Times said.

Mr. Long, it seems, has become a chimera, a combination of two people.

Guess what? There was an X-Files episode called “Chimera.”

Now, we’re not saying that all this proves aliens were involved, but … well … you know.



 

 

A place for everything

Nerthuz/iStock/Getty Images Plus

Our editor – imagine a combination of Mitch McConnell and SpongeBob SquarePants – is a big fan of the year-in-review list and said we should do one. But he turned down our idea for “Top 10 reasons not to do a year-in-review list,” so we’re doing the next-best thing: reporting on someone else’s.

We came across a list on Vice.com that was right up our alley, so to speak: “What did we get stuck in our rectums last year?”

It’s the latest edition of an annual list compiled by Barry Petchesky, who says he’s “been chronicling our country’s cavity misadventures” for a decade using data from the U.S. Consumer Product Safety Commission’s National Electronic Injury Surveillance System (NEISS) database.

After you’re done here, we strongly urge you to check out Mr. Petchesky’s full list, which covers all of the major bodily orifices and is not limited to rectums. In the meantime, here are a few highlights, with quotes from the actual NEISS reports when necessary:

  • Christmas ornament (ear).
  • Egg timer (rectum).
  • “Jumped off couch landed on spoon” (vagina).
  • Christmas ornament (nose).
  • Small shampoo bottle (rectum).
  • Large shampoo bottle (rectum).
  • Christmas ornament (throat).
  • “Was using prostate massager & it got ‘sucked in’ ” (rectum).
  • Coaxial cable (penis).
  • Christmas ornament (rectum).

The weather stinks today

Pavliha/E+

On the surface, the El Niño–Southern Oscillation isn’t the most impressive phenomenon in the world. The tropical eastern Pacific Ocean isn’t a small area, but there’s a lot of ocean out there, and the temperature difference from the norm during El Niño and its less well-known sister, La Niña, is only a few degrees.

But that blob of water can have massive effects on the world’s climate, causing drought and heat waves in some areas while being responsible for increased storms and massive amounts of rainfall and diarrhea in others.

“Wait, hang on – what was that last one?” you’re probably asking.

Yes, we’re going from “things stuck in our rectums” to “things very much not stuck in our rectums” thanks to a study published in Nature Communications. According to the researchers from Columbia University, La Niña (cooler water) is linked to increased diarrhea in young children in Botswana. During La Niña years, incidence of diarrhea in children aged 5 years or younger is 30% higher than in non–La Niña years.

It does make sense when you think about it. In southern Africa, La Niña is associated with cooler weather, increased rainfall, and more flooding during the rainy season. The aftermath of extreme rainfall events is often a breeding ground for waterborne pathogens. And so the diarrhea flows.

So, if you happen to be reading this from Botswana, pay attention to the news. If the meteorologists start talking about La Niña, you may want to stock up on oral rehydration salts and zinc.
 

 

 

Are two DNAs better than one?

Jezperklauzen/ThinkStock

Before you read any further, you need to find the X-Files theme to set the mood, so use this link and get it started.

Okay, is it on? No? That’s fine, we can wait.

Now are you ready? Good, here goes.

What happens after you receive a bone marrow transplant to treat acute myeloid leukemia? Many years of life, hopefully. But what if you survived and then started to turn into someone else? What if the DNA from the bone marrow donor started to replace your DNA?

Now you know why we needed the X-Files music.

Chris Long, who works at the Washoe County (Nev.) Sheriff’s Department, underwent a bone marrow transplant several years ago. Just before the procedure, a friend and colleague in the department, who just happened to run the crime lab, asked him for DNA samples.

Say, isn’t Area 51 in Nevada? Hmm, interesting.

A few months later, the lab determined that all of the DNA in his blood had been replaced by that of the bone marrow donor, the New York Times reported. And over the years, “swabs collected from his lip, cheek and tongue showed that these also contained his donor’s DNA, with the percentages rising and falling.”

Even more surprising? After 4 years, Mr. Long’s colleagues in the crime lab found that all of the DNA in his semen belonged to the donor, the Times said.

Mr. Long, it seems, has become a chimera, a combination of two people.

Guess what? There was an X-Files episode called “Chimera.”

Now, we’re not saying that all this proves aliens were involved, but … well … you know.



 

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Farxiga granted Priority Review for treatment of adults with HFrEF

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Tue, 05/03/2022 - 15:12

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.



The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

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The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.



The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.



The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

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Calif. woman poisoned by methylmercury-containing skin cream

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Wed, 01/08/2020 - 13:13

The first known case of contamination of skin-lightening cream with methylmercury was identified in July 2019 in a Mexican American woman in Sacramento, Calif., according to Anita Mudan, MD, of the department of emergency medicine at the University of California, San Francisco, and associates.

The woman, aged 47 years, sought medical care for dysesthesias and weakness in the upper extremities, the investigators wrote in a report published in Morbidity and Mortality Weekly Report.

This progressed to dysarthria, blurry vision, and unsteady gait over a 2-week period, leading to her hospitalization. Over the next 2 weeks, she declined into an agitated delirium; screening blood and urine tests detected levels of mercury exceeding the upper limit of quantification.

Oral dimercaptosuccinic acid at 10 mg/kg every 8 hours was administered via feeding tube. The California Department of Public Health (CDPH) conducted interviews with the patient’s family, discovering that the patient had used a skin-lightening cream obtained from Mexico for the past 7 years. The cream was analyzed and found to contain mercury at a concentration of 12,000 ppm. A Raman spectral analysis showed that the sample contained the organic compound methylmercury iodide.

Typically, contaminated skin-lightening creams contain inorganic mercury at levels up to 200,000 ppm; the significantly lower mercury content of the cream in this case “underscores the far higher toxicity of organic mercury compounds,” the investigators wrote.

The patient has undergone extensive chelation therapy, but remains unable to verbalize or care for herself, requiring continued tube feeding for nutritional support, Dr. Mudan and associates noted.

“CDPH is actively working to warn the public of this health risk, actively screening other skin lightening cream samples for mercury, and is investigating the case of a family member with likely exposure but less severe illness,” the investigators concluded.

The study authors reported that they had no conflicts of interest.

SOURCE: Mudan A et al. MMWR Morb Mortal Wkly Rep. 2019 Dec 20. doi: 10.15585/mmwr.mm6850a4.

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The first known case of contamination of skin-lightening cream with methylmercury was identified in July 2019 in a Mexican American woman in Sacramento, Calif., according to Anita Mudan, MD, of the department of emergency medicine at the University of California, San Francisco, and associates.

The woman, aged 47 years, sought medical care for dysesthesias and weakness in the upper extremities, the investigators wrote in a report published in Morbidity and Mortality Weekly Report.

This progressed to dysarthria, blurry vision, and unsteady gait over a 2-week period, leading to her hospitalization. Over the next 2 weeks, she declined into an agitated delirium; screening blood and urine tests detected levels of mercury exceeding the upper limit of quantification.

Oral dimercaptosuccinic acid at 10 mg/kg every 8 hours was administered via feeding tube. The California Department of Public Health (CDPH) conducted interviews with the patient’s family, discovering that the patient had used a skin-lightening cream obtained from Mexico for the past 7 years. The cream was analyzed and found to contain mercury at a concentration of 12,000 ppm. A Raman spectral analysis showed that the sample contained the organic compound methylmercury iodide.

Typically, contaminated skin-lightening creams contain inorganic mercury at levels up to 200,000 ppm; the significantly lower mercury content of the cream in this case “underscores the far higher toxicity of organic mercury compounds,” the investigators wrote.

The patient has undergone extensive chelation therapy, but remains unable to verbalize or care for herself, requiring continued tube feeding for nutritional support, Dr. Mudan and associates noted.

“CDPH is actively working to warn the public of this health risk, actively screening other skin lightening cream samples for mercury, and is investigating the case of a family member with likely exposure but less severe illness,” the investigators concluded.

The study authors reported that they had no conflicts of interest.

SOURCE: Mudan A et al. MMWR Morb Mortal Wkly Rep. 2019 Dec 20. doi: 10.15585/mmwr.mm6850a4.

The first known case of contamination of skin-lightening cream with methylmercury was identified in July 2019 in a Mexican American woman in Sacramento, Calif., according to Anita Mudan, MD, of the department of emergency medicine at the University of California, San Francisco, and associates.

The woman, aged 47 years, sought medical care for dysesthesias and weakness in the upper extremities, the investigators wrote in a report published in Morbidity and Mortality Weekly Report.

This progressed to dysarthria, blurry vision, and unsteady gait over a 2-week period, leading to her hospitalization. Over the next 2 weeks, she declined into an agitated delirium; screening blood and urine tests detected levels of mercury exceeding the upper limit of quantification.

Oral dimercaptosuccinic acid at 10 mg/kg every 8 hours was administered via feeding tube. The California Department of Public Health (CDPH) conducted interviews with the patient’s family, discovering that the patient had used a skin-lightening cream obtained from Mexico for the past 7 years. The cream was analyzed and found to contain mercury at a concentration of 12,000 ppm. A Raman spectral analysis showed that the sample contained the organic compound methylmercury iodide.

Typically, contaminated skin-lightening creams contain inorganic mercury at levels up to 200,000 ppm; the significantly lower mercury content of the cream in this case “underscores the far higher toxicity of organic mercury compounds,” the investigators wrote.

The patient has undergone extensive chelation therapy, but remains unable to verbalize or care for herself, requiring continued tube feeding for nutritional support, Dr. Mudan and associates noted.

“CDPH is actively working to warn the public of this health risk, actively screening other skin lightening cream samples for mercury, and is investigating the case of a family member with likely exposure but less severe illness,” the investigators concluded.

The study authors reported that they had no conflicts of interest.

SOURCE: Mudan A et al. MMWR Morb Mortal Wkly Rep. 2019 Dec 20. doi: 10.15585/mmwr.mm6850a4.

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Human hair’s super strength and boiled diabetes

Article Type
Changed
Thu, 01/16/2020 - 12:22

 

Stop us if you’ve heard this one

Dean Bertoncelj/iStockphoto
Hair salon

An elephant, a capybara, and a horse walk into a bar …

What? You’ve heard it? Really? … No, not really? You were just pulling our leg. Very funny.

Can we go on now? You’re sure? Because if there’s one thing we love, it’s reader participation.

Anyway, there’s this bar, and a bunch of researchers from the University of California’s San Diego and Berkeley campuses are hanging out with a bear, a boar, a javelina (looks and sounds like a pig, about the size of a border collie), and a giraffe when the aforementioned trio shows up.

They see all these mammals together and get an idea. Why not compare the tensile strength of their hair with that of a human adult and child? The next day, after sobering up, they started collecting hair samples.[Legal note: The situation at the bar is a literary device. At no time did the investigators conduct any of their work in such a place.]

Once that was done, uniaxial tension tests were conducted, as you would expect, using an Instron 3342 universal testing system equipped with a 500-N load cell at a strain rate of 10–2s–1.

The results, however, were not expected. Thin hairs are stronger than thick hairs. Hair from a human, with an average diameter of about 60 mcm, is stronger than hair from a boar (average diameter, 235 mcm) or a horse (average diameter, 200 mcm), and the weakest hair of all came from an elephant (diameter of 345 mcm) and a giraffe (diameter of 370 mcm). Also, the hair from the 9-year-old child is stronger than the thicker hair of the 30-year-old adult.

The results show that the inherent strength of human hair’s hierarchical structure – an outer layer, or cuticle, “wraps around an inner cortex made of many small fibers linked by chemical bonds” – makes it resistant to deformation, the investigators explained. They hope that synthetic materials with a similar structure could become lighter and stronger in the future.

Now what? The punchline? All this valuable hair information isn’t enough? Fine.

The shocked bartender, who’s already got the makings of a small zoo in his establishment, points a finger in alarm at the latest arrivals and yells, “Hey!” The horse says, “You read my mind, buddy.”


 

Boiled type 2 diabetes

amenic181/Getty Images

Ah, coffee. Is there anything it can’t do? From speeding up delivery of this tardy column (if not boosting its comedy quotient) to reducing the risk of type 2 diabetes, the magic bean seems nearly omnipotent. But java’s magical metabolic properties may be entirely dependent on how you brew your brown elixir.

Coffee-fueled Scandinavians have determined that the stimulating liquid’s antidiabetes effect is only possible when you don’t boil your beans. For those eager to ward off type 2 diabetes, filtered coffee – not boiled coffee – is the ticket to lower insulin resistance.

Researchers at Chalmers University of Technology in Gothenburg, Sweden, and Umeå (Sweden) University identified biomarkers that distinguished the consumption of filtered coffee from its boiled cousin. They found that people who drank two to three cups of filtered coffee a day enjoyed a 60% lower risk of type 2 diabetes than did those who subsisted on less than one cup of filtered coffee per day. But drinking boiled coffee did nothing to dent drinkers’ diabetes risk.

Why the difference? The coffee-sipping Swedish investigators say boiled coffee contains diterpenes, which don’t make it past a coffee filter. Other studies have shown diterpenes inflate the risk of heart and vascular diseases. And the researchers say those unfiltered diterpenes may sap your morning cuppa joe’s antidiabetes powers.

We know what you’re thinking: Who boils powdered coffee? Is Sanka even a thing anymore? It’s an approach that’s unfamiliar to most Mr. Coffee–owning Scandinavians and American java junkies alike. But before you, like us, take another smug sip from that cup you just made in the Keurig machine, know this: Coffee pod machines deal out hot, unfiltered brew.

Maybe just add two sugar packets next time. Your beta cells will thank you.
 

 

 

Let my people poop!

Panama7/iStock/Getty Images Plus

This is the way the world ends, this is the way the world ends: Not with a bang, but a tilted toilet.

The latest piece of late-stage capitalistic horror comes from Great Britain, and has lovingly been called the “StandardToilet.” No dystopian overtones there, absolutely not. The toilet’s “genius” lies in the seat’s 13-degree downward slope, which increases strain on the legs just like a squat thrust would. Sit on one for more than 5 minutes, and the pain becomes too much to handle.

The inventor of the StandardToilet claims that his product will cut time employees spend on the toilet by 25%, saving businesses as much as 4.8 billion pounds sterling a year. Not only that, he suggests that there are numerous health benefits, such as reduced hemorrhoid risk and a reduction of musculoskeletal disorders.

Critics were quick to point out that people with disabilities would likely have accessibility issues (and let’s not forget people with GI diseases), and a bathroom space expert (yes, that’s a thing) suggested that, if employees are spending too much time on the toilet, the issue is likely not laziness but the poor state of affairs in the workplace itself.

As purveyors of quality toilet- and poop-themed humor, we here at Livin’ on the MDedge world headquarters think it would be a shame if the giant corporations of the world took away normal toilets. So we say to the downtrodden proletariat: Workers of the world, unite! You have nothing to lose but your toilets!
 

Livin’ on the MDedge will be taking a holiday break, but we’ll be back to advance medical science in January!

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Stop us if you’ve heard this one

Dean Bertoncelj/iStockphoto
Hair salon

An elephant, a capybara, and a horse walk into a bar …

What? You’ve heard it? Really? … No, not really? You were just pulling our leg. Very funny.

Can we go on now? You’re sure? Because if there’s one thing we love, it’s reader participation.

Anyway, there’s this bar, and a bunch of researchers from the University of California’s San Diego and Berkeley campuses are hanging out with a bear, a boar, a javelina (looks and sounds like a pig, about the size of a border collie), and a giraffe when the aforementioned trio shows up.

They see all these mammals together and get an idea. Why not compare the tensile strength of their hair with that of a human adult and child? The next day, after sobering up, they started collecting hair samples.[Legal note: The situation at the bar is a literary device. At no time did the investigators conduct any of their work in such a place.]

Once that was done, uniaxial tension tests were conducted, as you would expect, using an Instron 3342 universal testing system equipped with a 500-N load cell at a strain rate of 10–2s–1.

The results, however, were not expected. Thin hairs are stronger than thick hairs. Hair from a human, with an average diameter of about 60 mcm, is stronger than hair from a boar (average diameter, 235 mcm) or a horse (average diameter, 200 mcm), and the weakest hair of all came from an elephant (diameter of 345 mcm) and a giraffe (diameter of 370 mcm). Also, the hair from the 9-year-old child is stronger than the thicker hair of the 30-year-old adult.

The results show that the inherent strength of human hair’s hierarchical structure – an outer layer, or cuticle, “wraps around an inner cortex made of many small fibers linked by chemical bonds” – makes it resistant to deformation, the investigators explained. They hope that synthetic materials with a similar structure could become lighter and stronger in the future.

Now what? The punchline? All this valuable hair information isn’t enough? Fine.

The shocked bartender, who’s already got the makings of a small zoo in his establishment, points a finger in alarm at the latest arrivals and yells, “Hey!” The horse says, “You read my mind, buddy.”


 

Boiled type 2 diabetes

amenic181/Getty Images

Ah, coffee. Is there anything it can’t do? From speeding up delivery of this tardy column (if not boosting its comedy quotient) to reducing the risk of type 2 diabetes, the magic bean seems nearly omnipotent. But java’s magical metabolic properties may be entirely dependent on how you brew your brown elixir.

Coffee-fueled Scandinavians have determined that the stimulating liquid’s antidiabetes effect is only possible when you don’t boil your beans. For those eager to ward off type 2 diabetes, filtered coffee – not boiled coffee – is the ticket to lower insulin resistance.

Researchers at Chalmers University of Technology in Gothenburg, Sweden, and Umeå (Sweden) University identified biomarkers that distinguished the consumption of filtered coffee from its boiled cousin. They found that people who drank two to three cups of filtered coffee a day enjoyed a 60% lower risk of type 2 diabetes than did those who subsisted on less than one cup of filtered coffee per day. But drinking boiled coffee did nothing to dent drinkers’ diabetes risk.

Why the difference? The coffee-sipping Swedish investigators say boiled coffee contains diterpenes, which don’t make it past a coffee filter. Other studies have shown diterpenes inflate the risk of heart and vascular diseases. And the researchers say those unfiltered diterpenes may sap your morning cuppa joe’s antidiabetes powers.

We know what you’re thinking: Who boils powdered coffee? Is Sanka even a thing anymore? It’s an approach that’s unfamiliar to most Mr. Coffee–owning Scandinavians and American java junkies alike. But before you, like us, take another smug sip from that cup you just made in the Keurig machine, know this: Coffee pod machines deal out hot, unfiltered brew.

Maybe just add two sugar packets next time. Your beta cells will thank you.
 

 

 

Let my people poop!

Panama7/iStock/Getty Images Plus

This is the way the world ends, this is the way the world ends: Not with a bang, but a tilted toilet.

The latest piece of late-stage capitalistic horror comes from Great Britain, and has lovingly been called the “StandardToilet.” No dystopian overtones there, absolutely not. The toilet’s “genius” lies in the seat’s 13-degree downward slope, which increases strain on the legs just like a squat thrust would. Sit on one for more than 5 minutes, and the pain becomes too much to handle.

The inventor of the StandardToilet claims that his product will cut time employees spend on the toilet by 25%, saving businesses as much as 4.8 billion pounds sterling a year. Not only that, he suggests that there are numerous health benefits, such as reduced hemorrhoid risk and a reduction of musculoskeletal disorders.

Critics were quick to point out that people with disabilities would likely have accessibility issues (and let’s not forget people with GI diseases), and a bathroom space expert (yes, that’s a thing) suggested that, if employees are spending too much time on the toilet, the issue is likely not laziness but the poor state of affairs in the workplace itself.

As purveyors of quality toilet- and poop-themed humor, we here at Livin’ on the MDedge world headquarters think it would be a shame if the giant corporations of the world took away normal toilets. So we say to the downtrodden proletariat: Workers of the world, unite! You have nothing to lose but your toilets!
 

Livin’ on the MDedge will be taking a holiday break, but we’ll be back to advance medical science in January!

 

Stop us if you’ve heard this one

Dean Bertoncelj/iStockphoto
Hair salon

An elephant, a capybara, and a horse walk into a bar …

What? You’ve heard it? Really? … No, not really? You were just pulling our leg. Very funny.

Can we go on now? You’re sure? Because if there’s one thing we love, it’s reader participation.

Anyway, there’s this bar, and a bunch of researchers from the University of California’s San Diego and Berkeley campuses are hanging out with a bear, a boar, a javelina (looks and sounds like a pig, about the size of a border collie), and a giraffe when the aforementioned trio shows up.

They see all these mammals together and get an idea. Why not compare the tensile strength of their hair with that of a human adult and child? The next day, after sobering up, they started collecting hair samples.[Legal note: The situation at the bar is a literary device. At no time did the investigators conduct any of their work in such a place.]

Once that was done, uniaxial tension tests were conducted, as you would expect, using an Instron 3342 universal testing system equipped with a 500-N load cell at a strain rate of 10–2s–1.

The results, however, were not expected. Thin hairs are stronger than thick hairs. Hair from a human, with an average diameter of about 60 mcm, is stronger than hair from a boar (average diameter, 235 mcm) or a horse (average diameter, 200 mcm), and the weakest hair of all came from an elephant (diameter of 345 mcm) and a giraffe (diameter of 370 mcm). Also, the hair from the 9-year-old child is stronger than the thicker hair of the 30-year-old adult.

The results show that the inherent strength of human hair’s hierarchical structure – an outer layer, or cuticle, “wraps around an inner cortex made of many small fibers linked by chemical bonds” – makes it resistant to deformation, the investigators explained. They hope that synthetic materials with a similar structure could become lighter and stronger in the future.

Now what? The punchline? All this valuable hair information isn’t enough? Fine.

The shocked bartender, who’s already got the makings of a small zoo in his establishment, points a finger in alarm at the latest arrivals and yells, “Hey!” The horse says, “You read my mind, buddy.”


 

Boiled type 2 diabetes

amenic181/Getty Images

Ah, coffee. Is there anything it can’t do? From speeding up delivery of this tardy column (if not boosting its comedy quotient) to reducing the risk of type 2 diabetes, the magic bean seems nearly omnipotent. But java’s magical metabolic properties may be entirely dependent on how you brew your brown elixir.

Coffee-fueled Scandinavians have determined that the stimulating liquid’s antidiabetes effect is only possible when you don’t boil your beans. For those eager to ward off type 2 diabetes, filtered coffee – not boiled coffee – is the ticket to lower insulin resistance.

Researchers at Chalmers University of Technology in Gothenburg, Sweden, and Umeå (Sweden) University identified biomarkers that distinguished the consumption of filtered coffee from its boiled cousin. They found that people who drank two to three cups of filtered coffee a day enjoyed a 60% lower risk of type 2 diabetes than did those who subsisted on less than one cup of filtered coffee per day. But drinking boiled coffee did nothing to dent drinkers’ diabetes risk.

Why the difference? The coffee-sipping Swedish investigators say boiled coffee contains diterpenes, which don’t make it past a coffee filter. Other studies have shown diterpenes inflate the risk of heart and vascular diseases. And the researchers say those unfiltered diterpenes may sap your morning cuppa joe’s antidiabetes powers.

We know what you’re thinking: Who boils powdered coffee? Is Sanka even a thing anymore? It’s an approach that’s unfamiliar to most Mr. Coffee–owning Scandinavians and American java junkies alike. But before you, like us, take another smug sip from that cup you just made in the Keurig machine, know this: Coffee pod machines deal out hot, unfiltered brew.

Maybe just add two sugar packets next time. Your beta cells will thank you.
 

 

 

Let my people poop!

Panama7/iStock/Getty Images Plus

This is the way the world ends, this is the way the world ends: Not with a bang, but a tilted toilet.

The latest piece of late-stage capitalistic horror comes from Great Britain, and has lovingly been called the “StandardToilet.” No dystopian overtones there, absolutely not. The toilet’s “genius” lies in the seat’s 13-degree downward slope, which increases strain on the legs just like a squat thrust would. Sit on one for more than 5 minutes, and the pain becomes too much to handle.

The inventor of the StandardToilet claims that his product will cut time employees spend on the toilet by 25%, saving businesses as much as 4.8 billion pounds sterling a year. Not only that, he suggests that there are numerous health benefits, such as reduced hemorrhoid risk and a reduction of musculoskeletal disorders.

Critics were quick to point out that people with disabilities would likely have accessibility issues (and let’s not forget people with GI diseases), and a bathroom space expert (yes, that’s a thing) suggested that, if employees are spending too much time on the toilet, the issue is likely not laziness but the poor state of affairs in the workplace itself.

As purveyors of quality toilet- and poop-themed humor, we here at Livin’ on the MDedge world headquarters think it would be a shame if the giant corporations of the world took away normal toilets. So we say to the downtrodden proletariat: Workers of the world, unite! You have nothing to lose but your toilets!
 

Livin’ on the MDedge will be taking a holiday break, but we’ll be back to advance medical science in January!

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Heart rate changes during sleep may be diagnostic tool for depression

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Mon, 01/13/2020 - 08:57

A heart rate–profiling algorithm shows promise at distinguishing differences in heart rate patterns during sleep between people with depression and healthy controls, research shows.

The algorithm was modeled using machine learning based on 1,203 polysomnograms from either people with depression or healthy controls, according to Mysa Saad, of the sleep research unit of the Royal’s Institute of Mental Health Research in Ottawa, and associates. That final algorithm was then tested on a new sample of 174 individuals (87 controls, 87 with depression) to categorize each person as either depressed or not depressed. This result was compared with medical record diagnoses. The study was published in BMC Psychiatry.

Compared with the control group, patients in the depression group slept 30.6 minutes less, had significantly longer sleep and REM onset latency, and had a lower amount of REM sleep as a percentage of total sleep time and in overall time. The algorithm incorrectly identified 15 patients with depression as being in the control group, and incorrectly identified 20 controls as having depression. The overall accuracy was 79.9%, with a sensitivity of 82.8% and a specificity of 77%.

“In addition to providing an improved biological underpinning for the diagnosis of depression, this [tool] could possibly offer supplemental information to psychiatric clinical assessment, and objective measures for early screening. Moreover, the use of distinct physiological variables as biomarkers of depression may help emphasize the interactions between mental and physical health. This may contribute to reducing the stigma associated with depression, lifting some social barriers to accessing psychiatric treatment, and allowing for more holistic patient care,” the investigators concluded.

Medibio provided partial funding for the salaries of research assistants; no other conflicts of interest were reported.

SOURCE: Saad M et al. BMC Psychiatry. 2019 Jun 7. doi: 10.1186/s12888-019-2152-1.

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A heart rate–profiling algorithm shows promise at distinguishing differences in heart rate patterns during sleep between people with depression and healthy controls, research shows.

The algorithm was modeled using machine learning based on 1,203 polysomnograms from either people with depression or healthy controls, according to Mysa Saad, of the sleep research unit of the Royal’s Institute of Mental Health Research in Ottawa, and associates. That final algorithm was then tested on a new sample of 174 individuals (87 controls, 87 with depression) to categorize each person as either depressed or not depressed. This result was compared with medical record diagnoses. The study was published in BMC Psychiatry.

Compared with the control group, patients in the depression group slept 30.6 minutes less, had significantly longer sleep and REM onset latency, and had a lower amount of REM sleep as a percentage of total sleep time and in overall time. The algorithm incorrectly identified 15 patients with depression as being in the control group, and incorrectly identified 20 controls as having depression. The overall accuracy was 79.9%, with a sensitivity of 82.8% and a specificity of 77%.

“In addition to providing an improved biological underpinning for the diagnosis of depression, this [tool] could possibly offer supplemental information to psychiatric clinical assessment, and objective measures for early screening. Moreover, the use of distinct physiological variables as biomarkers of depression may help emphasize the interactions between mental and physical health. This may contribute to reducing the stigma associated with depression, lifting some social barriers to accessing psychiatric treatment, and allowing for more holistic patient care,” the investigators concluded.

Medibio provided partial funding for the salaries of research assistants; no other conflicts of interest were reported.

SOURCE: Saad M et al. BMC Psychiatry. 2019 Jun 7. doi: 10.1186/s12888-019-2152-1.

A heart rate–profiling algorithm shows promise at distinguishing differences in heart rate patterns during sleep between people with depression and healthy controls, research shows.

The algorithm was modeled using machine learning based on 1,203 polysomnograms from either people with depression or healthy controls, according to Mysa Saad, of the sleep research unit of the Royal’s Institute of Mental Health Research in Ottawa, and associates. That final algorithm was then tested on a new sample of 174 individuals (87 controls, 87 with depression) to categorize each person as either depressed or not depressed. This result was compared with medical record diagnoses. The study was published in BMC Psychiatry.

Compared with the control group, patients in the depression group slept 30.6 minutes less, had significantly longer sleep and REM onset latency, and had a lower amount of REM sleep as a percentage of total sleep time and in overall time. The algorithm incorrectly identified 15 patients with depression as being in the control group, and incorrectly identified 20 controls as having depression. The overall accuracy was 79.9%, with a sensitivity of 82.8% and a specificity of 77%.

“In addition to providing an improved biological underpinning for the diagnosis of depression, this [tool] could possibly offer supplemental information to psychiatric clinical assessment, and objective measures for early screening. Moreover, the use of distinct physiological variables as biomarkers of depression may help emphasize the interactions between mental and physical health. This may contribute to reducing the stigma associated with depression, lifting some social barriers to accessing psychiatric treatment, and allowing for more holistic patient care,” the investigators concluded.

Medibio provided partial funding for the salaries of research assistants; no other conflicts of interest were reported.

SOURCE: Saad M et al. BMC Psychiatry. 2019 Jun 7. doi: 10.1186/s12888-019-2152-1.

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Schizophrenia, bipolar disorder associated with increased risk of secondary TD

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Fri, 12/13/2019 - 14:17

 

Psychiatric inpatients, particularly those with schizophrenia or bipolar disorder, have both a greater risk of having a secondary diagnosis of tardive dyskinesia and having worse illness when tardive dyskinesia is also present, according to results of a case-control study of more than 77,000 inpatients.

For the study, the investigators conducted an analysis of 77,022 adults from the Nationwide Inpatient Sample who had been admitted between January 2010 and December 2014 for mood disorders and schizophrenia; 38,382 patients in this group also had a secondary diagnosis of tardive dyskinesia (TD), reported Rikinkumar S. Patel, MD, of the department of psychiatry at Griffin Memorial Hospital in Norman, Okla., and associates. The study was published in Heliyon.

They investigators found that patients with schizophrenia and bipolar disorder were four to five times more likely to also have TD, and patients with TD were six times more likely to have severe morbidity because of a major loss of function. Compared with non-TD controls, patients with TD had a longer hospital length of stay by 6.36 days and higher cost by $20,415.

More than 60% of TD patients came from below the 50th percentile in median household income, compared with less than 40% of the non-TD group. Comorbidity-related risk factors for TD include diabetes (odds ratio, 1.542), hypertension (OR, 1.776), obesity (OR, 1.613), and tobacco (OR, 1.967) and drug abuse (OR, 1.507). Dr. Patel and associates also found that almost half of the patients with TD were aged 40-60 years and that the prevalence of TD in the study population increased with age.

“Our findings support the previous evidence that advanced age is a risk factor for the development of TD,” they wrote, citing research by Criscely L. Go, MD, and associates (Parkinsonism Relat Disord. 2019. 15[9]:655-9).

Dr. Patel and associates concluded that more systematic research is needed to prevent TD and “optimize inpatient outcomes in psychiatric patients with TD.”

The study authors reported having no conflicts of interest.

SOURCE: Patel RS et al. Heliyon. 2019. doi: 10.1016/j.heliyon.2019.e01745.

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Psychiatric inpatients, particularly those with schizophrenia or bipolar disorder, have both a greater risk of having a secondary diagnosis of tardive dyskinesia and having worse illness when tardive dyskinesia is also present, according to results of a case-control study of more than 77,000 inpatients.

For the study, the investigators conducted an analysis of 77,022 adults from the Nationwide Inpatient Sample who had been admitted between January 2010 and December 2014 for mood disorders and schizophrenia; 38,382 patients in this group also had a secondary diagnosis of tardive dyskinesia (TD), reported Rikinkumar S. Patel, MD, of the department of psychiatry at Griffin Memorial Hospital in Norman, Okla., and associates. The study was published in Heliyon.

They investigators found that patients with schizophrenia and bipolar disorder were four to five times more likely to also have TD, and patients with TD were six times more likely to have severe morbidity because of a major loss of function. Compared with non-TD controls, patients with TD had a longer hospital length of stay by 6.36 days and higher cost by $20,415.

More than 60% of TD patients came from below the 50th percentile in median household income, compared with less than 40% of the non-TD group. Comorbidity-related risk factors for TD include diabetes (odds ratio, 1.542), hypertension (OR, 1.776), obesity (OR, 1.613), and tobacco (OR, 1.967) and drug abuse (OR, 1.507). Dr. Patel and associates also found that almost half of the patients with TD were aged 40-60 years and that the prevalence of TD in the study population increased with age.

“Our findings support the previous evidence that advanced age is a risk factor for the development of TD,” they wrote, citing research by Criscely L. Go, MD, and associates (Parkinsonism Relat Disord. 2019. 15[9]:655-9).

Dr. Patel and associates concluded that more systematic research is needed to prevent TD and “optimize inpatient outcomes in psychiatric patients with TD.”

The study authors reported having no conflicts of interest.

SOURCE: Patel RS et al. Heliyon. 2019. doi: 10.1016/j.heliyon.2019.e01745.

 

Psychiatric inpatients, particularly those with schizophrenia or bipolar disorder, have both a greater risk of having a secondary diagnosis of tardive dyskinesia and having worse illness when tardive dyskinesia is also present, according to results of a case-control study of more than 77,000 inpatients.

For the study, the investigators conducted an analysis of 77,022 adults from the Nationwide Inpatient Sample who had been admitted between January 2010 and December 2014 for mood disorders and schizophrenia; 38,382 patients in this group also had a secondary diagnosis of tardive dyskinesia (TD), reported Rikinkumar S. Patel, MD, of the department of psychiatry at Griffin Memorial Hospital in Norman, Okla., and associates. The study was published in Heliyon.

They investigators found that patients with schizophrenia and bipolar disorder were four to five times more likely to also have TD, and patients with TD were six times more likely to have severe morbidity because of a major loss of function. Compared with non-TD controls, patients with TD had a longer hospital length of stay by 6.36 days and higher cost by $20,415.

More than 60% of TD patients came from below the 50th percentile in median household income, compared with less than 40% of the non-TD group. Comorbidity-related risk factors for TD include diabetes (odds ratio, 1.542), hypertension (OR, 1.776), obesity (OR, 1.613), and tobacco (OR, 1.967) and drug abuse (OR, 1.507). Dr. Patel and associates also found that almost half of the patients with TD were aged 40-60 years and that the prevalence of TD in the study population increased with age.

“Our findings support the previous evidence that advanced age is a risk factor for the development of TD,” they wrote, citing research by Criscely L. Go, MD, and associates (Parkinsonism Relat Disord. 2019. 15[9]:655-9).

Dr. Patel and associates concluded that more systematic research is needed to prevent TD and “optimize inpatient outcomes in psychiatric patients with TD.”

The study authors reported having no conflicts of interest.

SOURCE: Patel RS et al. Heliyon. 2019. doi: 10.1016/j.heliyon.2019.e01745.

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Tales of nasal terror, and dental hoverboarding

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Thu, 01/16/2020 - 12:22

 

A cure for nosiness

Christmas may be just around the corner, but is there ever really a wrong time to huddle around a campfire and swap scary stories? So bundle up, get the fire going, and prepare yourselves for a pair of nasal-based horror stories that will frighten your Jingle Bells off!

RusN/iStock/Getty Images Plus

Our first tale of nostril terror comes all the way from southern India, where a 13-year-old boy jumped into a water well to cool off. Hey, southern India gets hot, even in November. But like something out of a bad sci-fi movie, his peaceful swim was interrupted when something swam up his nose, causing him extreme pain. After a 30-minute procedure, the doctor pulled out the culprit: A horrific alien parasite! Okay, we’re lying; it was a fish. But we had you going, didn’t we?

Well, maybe that didn’t get you frightened. But we have more rhinal dread to share! A young girl in Las Vegas stuck a pair of plastic doll shoes up her nose, one in each nostril. Her mother removed one shoe, but neither she nor urgent care could reach the second. A trip to the hospital was in order, and once there, the doctors were able to remove the foreign object in seconds.

But as with all things in U.S. medicine, a reckoning would soon come. You feel it now, the dread in this woman’s heart when the hospital bill came.

She takes the envelope, and opens it slowly.

The paper unfolds, rough and heavy in her hands.

Her eyes scan the page, looking for the number, where is it, where is it? It must be here, it must be ...

$3,000.

That’s right, for this simple procedure, performed with a pair of fancy tweezers, the hospital saw fit to charge the hapless mother $3,000! AHHHHHHHHHHHH!

Some say that the mother’s high-deductible insurance policy reduced the cost to $1,700. But we ask you, does that make the story any less spooky? We think not.
 

Hoverboarding down the root canal

Time spent in the dentist’s chair is among the most anxiety-inducing in anyone’s life. The needles. The grinding. The drilling. The rinsing. The spitting. The throbbing copays.

RobertoDavid/iStock/Getty Images Plus

But you know what might inject a few cc’s of fun into your oral hygiene visits?

Did you guess ... a hoverboard?

If you did, well, you’re probably dentist Steve Martin in “Little Shop of Horrors.” Or perhaps Alaska dentist Seth Lookhart, who authorities say performed a tooth extraction on a sedated patient while Dr. Lookhart also rode a hoverboard. There are also charges of felony Medicaid fraud and reckless endangerment. And allegations of hefty theft from his practice partners. Oh, and a state board apparently suspended Dr. Lookhart’s dental license in 2017.

But hey, pulling teeth while taming a hoverboard? Photos or it didn’t happen, right?

Unfortunately for the well-balanced dentist, there are photos. Actually, there’s an entire video. And when prosecutors showed it to Dr. Lookhart’s unwitting and horrified costar, she was about as happy as the impacted wisdom teeth your teen kid’s still toting around.

Dr. Lookhart denied the felony fraud charges. But he did cop to the hoverboard. Which puts him one up on his cinematic “Wild and Crazy Guy” doppelganger. Even as a neurosurgeon in “The Man With Two Brains,” Mr. Martin never attempted to hoverboard while performing double “cranial screw-top” brain surgeries.
 

 

 

CSI: Quebec

They may live in that eternally polite land on the other side of our northern border, but they know where the bodies are buried. Lots of bodies. Some of them in shallow graves. Some of them in vehicles.

MicroStockHub/iStock/Getty Images Plus

No, we are not talking about Gil Grissom and the gang at CSI. We’re talking about the Secure Site for Research in Thanatology, also known as the “body farm,” which is scheduled to open this spring in Becancour, Quebec.

It’s the first such outdoor forensic facility in Canada and the first in the world – there are also body farms in the United States, Australia, and the Netherlands – to be located in a northern climate.

“We’re particularly interested in understanding what happens when a body is in subzero temperatures, when there’s a lot of snow on the ground, and how that freeze and then the thaw process might actually change the rate of decomposition,” Shari Forbes, the farm’s director, told CTV News recently.

The science team will be out on the farm every day, meticulously checking each body – talk about making a list and checking it twice – for all the important CSI stuff: how long fingerprints and DNA evidence last, the effects of insect feeding and egg-laying, and the ability of dogs to detect scents.

The decomposition process in a cold climate will be a strange and wondrous journey, and the body farm’s work can, perhaps, best be summed up by none other than Mr. Grissom, who once said that getting to the evidence means having to destroy the evidence.

Then again, he also said that “dead men don’t ride roller coasters,” so the analogy only goes so far.

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A cure for nosiness

Christmas may be just around the corner, but is there ever really a wrong time to huddle around a campfire and swap scary stories? So bundle up, get the fire going, and prepare yourselves for a pair of nasal-based horror stories that will frighten your Jingle Bells off!

RusN/iStock/Getty Images Plus

Our first tale of nostril terror comes all the way from southern India, where a 13-year-old boy jumped into a water well to cool off. Hey, southern India gets hot, even in November. But like something out of a bad sci-fi movie, his peaceful swim was interrupted when something swam up his nose, causing him extreme pain. After a 30-minute procedure, the doctor pulled out the culprit: A horrific alien parasite! Okay, we’re lying; it was a fish. But we had you going, didn’t we?

Well, maybe that didn’t get you frightened. But we have more rhinal dread to share! A young girl in Las Vegas stuck a pair of plastic doll shoes up her nose, one in each nostril. Her mother removed one shoe, but neither she nor urgent care could reach the second. A trip to the hospital was in order, and once there, the doctors were able to remove the foreign object in seconds.

But as with all things in U.S. medicine, a reckoning would soon come. You feel it now, the dread in this woman’s heart when the hospital bill came.

She takes the envelope, and opens it slowly.

The paper unfolds, rough and heavy in her hands.

Her eyes scan the page, looking for the number, where is it, where is it? It must be here, it must be ...

$3,000.

That’s right, for this simple procedure, performed with a pair of fancy tweezers, the hospital saw fit to charge the hapless mother $3,000! AHHHHHHHHHHHH!

Some say that the mother’s high-deductible insurance policy reduced the cost to $1,700. But we ask you, does that make the story any less spooky? We think not.
 

Hoverboarding down the root canal

Time spent in the dentist’s chair is among the most anxiety-inducing in anyone’s life. The needles. The grinding. The drilling. The rinsing. The spitting. The throbbing copays.

RobertoDavid/iStock/Getty Images Plus

But you know what might inject a few cc’s of fun into your oral hygiene visits?

Did you guess ... a hoverboard?

If you did, well, you’re probably dentist Steve Martin in “Little Shop of Horrors.” Or perhaps Alaska dentist Seth Lookhart, who authorities say performed a tooth extraction on a sedated patient while Dr. Lookhart also rode a hoverboard. There are also charges of felony Medicaid fraud and reckless endangerment. And allegations of hefty theft from his practice partners. Oh, and a state board apparently suspended Dr. Lookhart’s dental license in 2017.

But hey, pulling teeth while taming a hoverboard? Photos or it didn’t happen, right?

Unfortunately for the well-balanced dentist, there are photos. Actually, there’s an entire video. And when prosecutors showed it to Dr. Lookhart’s unwitting and horrified costar, she was about as happy as the impacted wisdom teeth your teen kid’s still toting around.

Dr. Lookhart denied the felony fraud charges. But he did cop to the hoverboard. Which puts him one up on his cinematic “Wild and Crazy Guy” doppelganger. Even as a neurosurgeon in “The Man With Two Brains,” Mr. Martin never attempted to hoverboard while performing double “cranial screw-top” brain surgeries.
 

 

 

CSI: Quebec

They may live in that eternally polite land on the other side of our northern border, but they know where the bodies are buried. Lots of bodies. Some of them in shallow graves. Some of them in vehicles.

MicroStockHub/iStock/Getty Images Plus

No, we are not talking about Gil Grissom and the gang at CSI. We’re talking about the Secure Site for Research in Thanatology, also known as the “body farm,” which is scheduled to open this spring in Becancour, Quebec.

It’s the first such outdoor forensic facility in Canada and the first in the world – there are also body farms in the United States, Australia, and the Netherlands – to be located in a northern climate.

“We’re particularly interested in understanding what happens when a body is in subzero temperatures, when there’s a lot of snow on the ground, and how that freeze and then the thaw process might actually change the rate of decomposition,” Shari Forbes, the farm’s director, told CTV News recently.

The science team will be out on the farm every day, meticulously checking each body – talk about making a list and checking it twice – for all the important CSI stuff: how long fingerprints and DNA evidence last, the effects of insect feeding and egg-laying, and the ability of dogs to detect scents.

The decomposition process in a cold climate will be a strange and wondrous journey, and the body farm’s work can, perhaps, best be summed up by none other than Mr. Grissom, who once said that getting to the evidence means having to destroy the evidence.

Then again, he also said that “dead men don’t ride roller coasters,” so the analogy only goes so far.

 

A cure for nosiness

Christmas may be just around the corner, but is there ever really a wrong time to huddle around a campfire and swap scary stories? So bundle up, get the fire going, and prepare yourselves for a pair of nasal-based horror stories that will frighten your Jingle Bells off!

RusN/iStock/Getty Images Plus

Our first tale of nostril terror comes all the way from southern India, where a 13-year-old boy jumped into a water well to cool off. Hey, southern India gets hot, even in November. But like something out of a bad sci-fi movie, his peaceful swim was interrupted when something swam up his nose, causing him extreme pain. After a 30-minute procedure, the doctor pulled out the culprit: A horrific alien parasite! Okay, we’re lying; it was a fish. But we had you going, didn’t we?

Well, maybe that didn’t get you frightened. But we have more rhinal dread to share! A young girl in Las Vegas stuck a pair of plastic doll shoes up her nose, one in each nostril. Her mother removed one shoe, but neither she nor urgent care could reach the second. A trip to the hospital was in order, and once there, the doctors were able to remove the foreign object in seconds.

But as with all things in U.S. medicine, a reckoning would soon come. You feel it now, the dread in this woman’s heart when the hospital bill came.

She takes the envelope, and opens it slowly.

The paper unfolds, rough and heavy in her hands.

Her eyes scan the page, looking for the number, where is it, where is it? It must be here, it must be ...

$3,000.

That’s right, for this simple procedure, performed with a pair of fancy tweezers, the hospital saw fit to charge the hapless mother $3,000! AHHHHHHHHHHHH!

Some say that the mother’s high-deductible insurance policy reduced the cost to $1,700. But we ask you, does that make the story any less spooky? We think not.
 

Hoverboarding down the root canal

Time spent in the dentist’s chair is among the most anxiety-inducing in anyone’s life. The needles. The grinding. The drilling. The rinsing. The spitting. The throbbing copays.

RobertoDavid/iStock/Getty Images Plus

But you know what might inject a few cc’s of fun into your oral hygiene visits?

Did you guess ... a hoverboard?

If you did, well, you’re probably dentist Steve Martin in “Little Shop of Horrors.” Or perhaps Alaska dentist Seth Lookhart, who authorities say performed a tooth extraction on a sedated patient while Dr. Lookhart also rode a hoverboard. There are also charges of felony Medicaid fraud and reckless endangerment. And allegations of hefty theft from his practice partners. Oh, and a state board apparently suspended Dr. Lookhart’s dental license in 2017.

But hey, pulling teeth while taming a hoverboard? Photos or it didn’t happen, right?

Unfortunately for the well-balanced dentist, there are photos. Actually, there’s an entire video. And when prosecutors showed it to Dr. Lookhart’s unwitting and horrified costar, she was about as happy as the impacted wisdom teeth your teen kid’s still toting around.

Dr. Lookhart denied the felony fraud charges. But he did cop to the hoverboard. Which puts him one up on his cinematic “Wild and Crazy Guy” doppelganger. Even as a neurosurgeon in “The Man With Two Brains,” Mr. Martin never attempted to hoverboard while performing double “cranial screw-top” brain surgeries.
 

 

 

CSI: Quebec

They may live in that eternally polite land on the other side of our northern border, but they know where the bodies are buried. Lots of bodies. Some of them in shallow graves. Some of them in vehicles.

MicroStockHub/iStock/Getty Images Plus

No, we are not talking about Gil Grissom and the gang at CSI. We’re talking about the Secure Site for Research in Thanatology, also known as the “body farm,” which is scheduled to open this spring in Becancour, Quebec.

It’s the first such outdoor forensic facility in Canada and the first in the world – there are also body farms in the United States, Australia, and the Netherlands – to be located in a northern climate.

“We’re particularly interested in understanding what happens when a body is in subzero temperatures, when there’s a lot of snow on the ground, and how that freeze and then the thaw process might actually change the rate of decomposition,” Shari Forbes, the farm’s director, told CTV News recently.

The science team will be out on the farm every day, meticulously checking each body – talk about making a list and checking it twice – for all the important CSI stuff: how long fingerprints and DNA evidence last, the effects of insect feeding and egg-laying, and the ability of dogs to detect scents.

The decomposition process in a cold climate will be a strange and wondrous journey, and the body farm’s work can, perhaps, best be summed up by none other than Mr. Grissom, who once said that getting to the evidence means having to destroy the evidence.

Then again, he also said that “dead men don’t ride roller coasters,” so the analogy only goes so far.

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FDA investigates NDMA contamination in metformin

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Tue, 05/03/2022 - 15:12

The Food and Drug Administration is investigating whether forms of the type 2 diabetes drug metformin that are available in the United States contain the genotoxic nitrosamine, N-nitrosodimethylamine (NDMA).

Dr. Janet Woodcock

This follows reports of low-level NDMA contamination of metformin in other countries and of a few regulatory agencies issuing recalls for the drug, according to a statement from Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“There are no metformin recalls affecting the U.S. market at this time,” the agency emphasized in the statement. It said NDMA levels in affected medication have been low, at or even below the acceptable intake limit, and there is currently no evidence indicating that metformin drugs within the United States or European Union have been contaminated.

The FDA advised that patients should continue taking metformin alone or in combination with other drugs to control their diabetes and that it would be dangerous for them to stop taking the medication without first discussing it with their providers. It also recommended that providers continue to use metformin when “clinically appropriate” while the investigation is underway as there are no alternative therapies to treat the disease in the same way.

NDMA is a common contaminant that is found in water and some foods and has probable carcinogenic effects when exposure is too high. The acceptable daily intake for NDMA in the United States is 96 ng/day, according to the statement, though people who take in that amount or less every day for 70 years are not expected to have an increased risk of cancer.

Both the FDA and its counterpart, the European Medicines Agency, have recently investigated the presence of NDMA impurities in ranitidine, a drug used to reduce production of stomach acid, which led to several manufacturers issuing recalls for it.

The agencies have also investigated angiotensin II receptor blockers, which are used to treat hypertension, heart failure, and high blood pressure.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The presence of NDMA “can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed,” Dr. Woodcock noted in the statement.

“We are monitoring this issue closely to assess any potential impact on patients with diabetes,” said Robert W. Lash, MD, chief professional and clinical affairs officer of the Endocrine Society. “We have members around the world and are concerned about the possibility of carcinogenic impurities in medications, both in the United States and elsewhere.”

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The Food and Drug Administration is investigating whether forms of the type 2 diabetes drug metformin that are available in the United States contain the genotoxic nitrosamine, N-nitrosodimethylamine (NDMA).

Dr. Janet Woodcock

This follows reports of low-level NDMA contamination of metformin in other countries and of a few regulatory agencies issuing recalls for the drug, according to a statement from Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“There are no metformin recalls affecting the U.S. market at this time,” the agency emphasized in the statement. It said NDMA levels in affected medication have been low, at or even below the acceptable intake limit, and there is currently no evidence indicating that metformin drugs within the United States or European Union have been contaminated.

The FDA advised that patients should continue taking metformin alone or in combination with other drugs to control their diabetes and that it would be dangerous for them to stop taking the medication without first discussing it with their providers. It also recommended that providers continue to use metformin when “clinically appropriate” while the investigation is underway as there are no alternative therapies to treat the disease in the same way.

NDMA is a common contaminant that is found in water and some foods and has probable carcinogenic effects when exposure is too high. The acceptable daily intake for NDMA in the United States is 96 ng/day, according to the statement, though people who take in that amount or less every day for 70 years are not expected to have an increased risk of cancer.

Both the FDA and its counterpart, the European Medicines Agency, have recently investigated the presence of NDMA impurities in ranitidine, a drug used to reduce production of stomach acid, which led to several manufacturers issuing recalls for it.

The agencies have also investigated angiotensin II receptor blockers, which are used to treat hypertension, heart failure, and high blood pressure.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The presence of NDMA “can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed,” Dr. Woodcock noted in the statement.

“We are monitoring this issue closely to assess any potential impact on patients with diabetes,” said Robert W. Lash, MD, chief professional and clinical affairs officer of the Endocrine Society. “We have members around the world and are concerned about the possibility of carcinogenic impurities in medications, both in the United States and elsewhere.”

The Food and Drug Administration is investigating whether forms of the type 2 diabetes drug metformin that are available in the United States contain the genotoxic nitrosamine, N-nitrosodimethylamine (NDMA).

Dr. Janet Woodcock

This follows reports of low-level NDMA contamination of metformin in other countries and of a few regulatory agencies issuing recalls for the drug, according to a statement from Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“There are no metformin recalls affecting the U.S. market at this time,” the agency emphasized in the statement. It said NDMA levels in affected medication have been low, at or even below the acceptable intake limit, and there is currently no evidence indicating that metformin drugs within the United States or European Union have been contaminated.

The FDA advised that patients should continue taking metformin alone or in combination with other drugs to control their diabetes and that it would be dangerous for them to stop taking the medication without first discussing it with their providers. It also recommended that providers continue to use metformin when “clinically appropriate” while the investigation is underway as there are no alternative therapies to treat the disease in the same way.

NDMA is a common contaminant that is found in water and some foods and has probable carcinogenic effects when exposure is too high. The acceptable daily intake for NDMA in the United States is 96 ng/day, according to the statement, though people who take in that amount or less every day for 70 years are not expected to have an increased risk of cancer.

Both the FDA and its counterpart, the European Medicines Agency, have recently investigated the presence of NDMA impurities in ranitidine, a drug used to reduce production of stomach acid, which led to several manufacturers issuing recalls for it.

The agencies have also investigated angiotensin II receptor blockers, which are used to treat hypertension, heart failure, and high blood pressure.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The presence of NDMA “can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed,” Dr. Woodcock noted in the statement.

“We are monitoring this issue closely to assess any potential impact on patients with diabetes,” said Robert W. Lash, MD, chief professional and clinical affairs officer of the Endocrine Society. “We have members around the world and are concerned about the possibility of carcinogenic impurities in medications, both in the United States and elsewhere.”

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