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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 approves Gadavist for evaluation of supra-aortic, renal artery disease
The Food and Drug Administration has approved gadobutrol (Gadavist) injections, for use in conjunction with magnetic resonance angiography (MRA), to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients.
Approval was based on a pair of open-label, phase 3 studies in which the efficacy of gadobutrol was assessed, based on visualization and performance for distinguishing between normal and abnormal anatomy. MRA with gadobutrol improved visualization by 88%-98%, compared with unenhanced MRA, in which visualization was improved by 24%-82%. Sensitivity and specificity were noninferior to unenhanced MRA.
Gadobutrol was previously indicated for use in diagnostic MRI in both adults and children to detect areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system, and for MRI of the breast to assess the presence and extent of malignant breast disease. The safety profile in the two current trials matched data previously gathered, with the most common adverse events including headache, nausea, and dizziness.
“Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries. With FDA’s action, radiologists now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack,” Elias Melhem, MD, chair of the department of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, said in the press release.
Find the full release on the Bayer website.
The Food and Drug Administration has approved gadobutrol (Gadavist) injections, for use in conjunction with magnetic resonance angiography (MRA), to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients.
Approval was based on a pair of open-label, phase 3 studies in which the efficacy of gadobutrol was assessed, based on visualization and performance for distinguishing between normal and abnormal anatomy. MRA with gadobutrol improved visualization by 88%-98%, compared with unenhanced MRA, in which visualization was improved by 24%-82%. Sensitivity and specificity were noninferior to unenhanced MRA.
Gadobutrol was previously indicated for use in diagnostic MRI in both adults and children to detect areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system, and for MRI of the breast to assess the presence and extent of malignant breast disease. The safety profile in the two current trials matched data previously gathered, with the most common adverse events including headache, nausea, and dizziness.
“Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries. With FDA’s action, radiologists now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack,” Elias Melhem, MD, chair of the department of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, said in the press release.
Find the full release on the Bayer website.
The Food and Drug Administration has approved gadobutrol (Gadavist) injections, for use in conjunction with magnetic resonance angiography (MRA), to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients.
Approval was based on a pair of open-label, phase 3 studies in which the efficacy of gadobutrol was assessed, based on visualization and performance for distinguishing between normal and abnormal anatomy. MRA with gadobutrol improved visualization by 88%-98%, compared with unenhanced MRA, in which visualization was improved by 24%-82%. Sensitivity and specificity were noninferior to unenhanced MRA.
Gadobutrol was previously indicated for use in diagnostic MRI in both adults and children to detect areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system, and for MRI of the breast to assess the presence and extent of malignant breast disease. The safety profile in the two current trials matched data previously gathered, with the most common adverse events including headache, nausea, and dizziness.
“Until now, no contrast agents were FDA approved for use with MRA of the supra-aortic arteries. With FDA’s action, radiologists now have an approved MRA contrast agent to help visualize supra-aortic arteries in patients with known or suspected supra-aortic arterial disease, including conditions such as prior stroke or transient ischemic attack,” Elias Melhem, MD, chair of the department of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, said in the press release.
Find the full release on the Bayer website.
Smartphone-based system rivals clinical assessments of anxiety in bipolar disorder
In patients with bipolar disorder currently in partial or full remission, self-reporting of anxiety to a smartphone-based system matched clinical evaluations of anxiety, according to Maria Faurholt-Jepsen, MD, and her associates.
A total of 84 patients with bipolar disorder who participated in the randomized, controlled, single-blind, parallel-group MONARCA II trial were included in the study, reported Dr. Faurholt-Jepsen of Rigshospitalet in Copenhagen, and her associates. All patients reported their anxiety to the smartphone-based system every day for a 9-month period; all patients underwent clinical evaluations of anxiety, functioning, patient-reported stress, and quality of life at five fixed time points over the study period. The study was published online by the Journal of Affective Disorders.
Self-reported anxiety was mild, with 19.3% of patients reporting anxiety during the study period, and 2.6% reporting severe anxiety. No association was seen between gender and anxiety days, or between bipolar disorder type and anxiety days. Patients reported depressed mood on 43.2% of the days when anxiety was also reported, and reported mania on 48.0% of the days when anxiety was reported.
Self-reported anxiety scores were positively associated with the anxiety subitems on a key rating scale (P = .0001). In addition, self-reported anxiety was associated with perceived stress, quality of life, and functioning (P = .0001 for all three).
“ Frequent fine-grained monitoring in clinical, high-risk and epidemiological populations provides an opportunity to gain a better understanding of the nature, correlates, and clinical implications of [bipolar disorder],” the investigators wrote.
Three coauthors reported consulting with Eli Lilly, Astra Zeneca, Servier, Bristol-Myers Squibb, Lundbeck, Sunovion, and Medilink. Two coauthors are cofounders and shareholders in Monsenso.
SOURCE: Faurholt-Jepsen M et al. J Affect Disord. 2019. doi: 10.1016/j.jad.2019.07.029.
In patients with bipolar disorder currently in partial or full remission, self-reporting of anxiety to a smartphone-based system matched clinical evaluations of anxiety, according to Maria Faurholt-Jepsen, MD, and her associates.
A total of 84 patients with bipolar disorder who participated in the randomized, controlled, single-blind, parallel-group MONARCA II trial were included in the study, reported Dr. Faurholt-Jepsen of Rigshospitalet in Copenhagen, and her associates. All patients reported their anxiety to the smartphone-based system every day for a 9-month period; all patients underwent clinical evaluations of anxiety, functioning, patient-reported stress, and quality of life at five fixed time points over the study period. The study was published online by the Journal of Affective Disorders.
Self-reported anxiety was mild, with 19.3% of patients reporting anxiety during the study period, and 2.6% reporting severe anxiety. No association was seen between gender and anxiety days, or between bipolar disorder type and anxiety days. Patients reported depressed mood on 43.2% of the days when anxiety was also reported, and reported mania on 48.0% of the days when anxiety was reported.
Self-reported anxiety scores were positively associated with the anxiety subitems on a key rating scale (P = .0001). In addition, self-reported anxiety was associated with perceived stress, quality of life, and functioning (P = .0001 for all three).
“ Frequent fine-grained monitoring in clinical, high-risk and epidemiological populations provides an opportunity to gain a better understanding of the nature, correlates, and clinical implications of [bipolar disorder],” the investigators wrote.
Three coauthors reported consulting with Eli Lilly, Astra Zeneca, Servier, Bristol-Myers Squibb, Lundbeck, Sunovion, and Medilink. Two coauthors are cofounders and shareholders in Monsenso.
SOURCE: Faurholt-Jepsen M et al. J Affect Disord. 2019. doi: 10.1016/j.jad.2019.07.029.
In patients with bipolar disorder currently in partial or full remission, self-reporting of anxiety to a smartphone-based system matched clinical evaluations of anxiety, according to Maria Faurholt-Jepsen, MD, and her associates.
A total of 84 patients with bipolar disorder who participated in the randomized, controlled, single-blind, parallel-group MONARCA II trial were included in the study, reported Dr. Faurholt-Jepsen of Rigshospitalet in Copenhagen, and her associates. All patients reported their anxiety to the smartphone-based system every day for a 9-month period; all patients underwent clinical evaluations of anxiety, functioning, patient-reported stress, and quality of life at five fixed time points over the study period. The study was published online by the Journal of Affective Disorders.
Self-reported anxiety was mild, with 19.3% of patients reporting anxiety during the study period, and 2.6% reporting severe anxiety. No association was seen between gender and anxiety days, or between bipolar disorder type and anxiety days. Patients reported depressed mood on 43.2% of the days when anxiety was also reported, and reported mania on 48.0% of the days when anxiety was reported.
Self-reported anxiety scores were positively associated with the anxiety subitems on a key rating scale (P = .0001). In addition, self-reported anxiety was associated with perceived stress, quality of life, and functioning (P = .0001 for all three).
“ Frequent fine-grained monitoring in clinical, high-risk and epidemiological populations provides an opportunity to gain a better understanding of the nature, correlates, and clinical implications of [bipolar disorder],” the investigators wrote.
Three coauthors reported consulting with Eli Lilly, Astra Zeneca, Servier, Bristol-Myers Squibb, Lundbeck, Sunovion, and Medilink. Two coauthors are cofounders and shareholders in Monsenso.
SOURCE: Faurholt-Jepsen M et al. J Affect Disord. 2019. doi: 10.1016/j.jad.2019.07.029.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Dancing parrots, flying spiders, and ER fish tales
Cockatoo cha-cha-cha
Humans love to dance. Whether it’s just a little bobbing back and forth or a full-on tango, spontaneous dancing is a universal expression of feeling and joy. However, feeling the rhythm is nearly unique to the human species. Not even our closest relatives in the animal kingdom, primates, have been observed busting a move to music.
So who are our ballroom brethren? Parrots, strangely enough. Parrots are nature’s great imitators, so how can we be sure they aren’t just mimicking (or mocking) their human owners’ movements?
Several studies have been conducted on a particularly funky cockatoo named Snowball. He’s a viral Internet sensation, and researchers have been watching him for the past decade as he stomps his feet and bangs his head to all kinds of music – he jams to everything from classic rock to modern pop. Snowball’s owner also assured scientists that her bird does not get his dance moves from her; Snowball is a unique choreographer.
A follow-up study about Snowball was recently published, in which the authors suggested the reason for spontaneous parrot dancing could be the strong auditory-motor connections that exist in parrot brains. They’re similar to humans, but not primates. They also detailed Snowball’s 14 distinct dance moves. Someone get that parrot on America’s Got Talent, ASAP.
It’s a bird, it’s a plane – oh no, it’s a spider
Arachnophobes, just skip this one. If you’re not unsettled by spiders yet, you’re about to be!
In case you didn’t know, spiders can fly. Or rather, they float (spiders with wings would just be straight-up horrifying).
Scientists (and fans of Charlotte’s Web) have known for centuries that spiders can turn into their own personal airships, but it wasn’t always clear how they do it. It was commonly believed that spider-flying, aka “ballooning,” was caused by the spider using its silk as a kind of kite, with the wind catching on the silk and bringing the spider along with it. That explanation, however, doesn’t account for the fact that spiders only balloon during light winds, which are rarely strong enough to carry a spider.
Two intrepid spider fans from the University of Bristol (England) think they have solved the mystery of the flying arachnids.
It turns out that spiders are able to sense the earth’s electric field and use that to soar around. They let loose some silk, which picks up a negative charge. This charge repels the negative charge of whatever they are standing on and can create enough force to launch them into the air. Spiders, those smart little buggers, can increase these charges by climbing onto twigs or grass. Plants rooted in the earth have a strong negative charge but stick up into the positively charged air.
All this fancy science-babble to say: Spiders can fly, and we know how! Stay indoors, folks.
Hospital lures fishermen to ED
There are some things you expect to see when you walk into a hospital: an admitting desk, waiting areas full of people, security guards, bad art work, maybe a friendly greeter at the door (sorry, that’s the Walmart).
The main lobby at Adirondack Medical Center in Saranac Lake, N.Y., however, has something you might not expect: a display of fishing lures.
Each of the more than 100 lures on display originally showed up at the hospital’s emergency department attached to an arm, leg, nose, or lip – pretty much every body part possible, Gary Nye, a physician assistant in the ED, told newyorkupstate.com. He’s even removed lures from several patients’ penises and scrotums. “Usually alcohol has something to do with it,” he noted.
One individual came in with hooks from a lure stuck on both thumbs. He got one set of hooks stuck on one thumb, and as he tried to get it out, he ended up getting the lure’s other set of hooks caught on his other thumb. A nurse who has worked in the ED for 20 years said that alcohol may been involved.
Dr. Michael Pond, the hospital’s former medical director and the one who started the display in 1990, explained why the lures are now kept in a locked case. A number of years ago, when the display was less secure, “someone cut out and stole four to five antique lures out of the case. I mean, these were absolutely gorgeous and expensive lures – Pikie Minnows and [other] things. [They] were made out of wood and painted.”
As with so many fish stories, you should have seen the one that got away.
Inspiration really can come from anywhere
On the surface, a study detailing a new, potentially practice-changing method of converting type A blood to type O doesn’t seem disgusting, silly, or odd enough to make it into Livin’ on the MDedge. But when you dig a little deeper, you’ll see that the method involves a bacteria in the human microbiome.
Now you might be getting a bit suspicious. This is going to be another story about poop, you might be thinking.
And you’d be right!
But the real star of the show isn’t human poop. No, in this case, we owe this groundbreaking discovery to the humble beaver.
In an earlier study published in the ISME Journal, the same group of researchers from the University of British Columbia in Vancouver (of course they’re Canadian) analyzed the microbiomes of beavers to see just how they broke down the complex carbohydrates and glycoproteins found in wood. That was the catalyst that got the researchers thinking about the human microbiome and the problem of stripping red blood cells of their antigens.
Basically, just as the beaver breaks down wood with bacteria in their microbiome, the modified bacteria the researchers conjured up can be used to break down the A and B antigens of red blood cells, leaving a simple type O cell that can be transfused into any patient.
Rumors that all future blood transfusions are required by law to be accompanied by a playing of O Canada remain unsubstantiated.
Cockatoo cha-cha-cha
Humans love to dance. Whether it’s just a little bobbing back and forth or a full-on tango, spontaneous dancing is a universal expression of feeling and joy. However, feeling the rhythm is nearly unique to the human species. Not even our closest relatives in the animal kingdom, primates, have been observed busting a move to music.
So who are our ballroom brethren? Parrots, strangely enough. Parrots are nature’s great imitators, so how can we be sure they aren’t just mimicking (or mocking) their human owners’ movements?
Several studies have been conducted on a particularly funky cockatoo named Snowball. He’s a viral Internet sensation, and researchers have been watching him for the past decade as he stomps his feet and bangs his head to all kinds of music – he jams to everything from classic rock to modern pop. Snowball’s owner also assured scientists that her bird does not get his dance moves from her; Snowball is a unique choreographer.
A follow-up study about Snowball was recently published, in which the authors suggested the reason for spontaneous parrot dancing could be the strong auditory-motor connections that exist in parrot brains. They’re similar to humans, but not primates. They also detailed Snowball’s 14 distinct dance moves. Someone get that parrot on America’s Got Talent, ASAP.
It’s a bird, it’s a plane – oh no, it’s a spider
Arachnophobes, just skip this one. If you’re not unsettled by spiders yet, you’re about to be!
In case you didn’t know, spiders can fly. Or rather, they float (spiders with wings would just be straight-up horrifying).
Scientists (and fans of Charlotte’s Web) have known for centuries that spiders can turn into their own personal airships, but it wasn’t always clear how they do it. It was commonly believed that spider-flying, aka “ballooning,” was caused by the spider using its silk as a kind of kite, with the wind catching on the silk and bringing the spider along with it. That explanation, however, doesn’t account for the fact that spiders only balloon during light winds, which are rarely strong enough to carry a spider.
Two intrepid spider fans from the University of Bristol (England) think they have solved the mystery of the flying arachnids.
It turns out that spiders are able to sense the earth’s electric field and use that to soar around. They let loose some silk, which picks up a negative charge. This charge repels the negative charge of whatever they are standing on and can create enough force to launch them into the air. Spiders, those smart little buggers, can increase these charges by climbing onto twigs or grass. Plants rooted in the earth have a strong negative charge but stick up into the positively charged air.
All this fancy science-babble to say: Spiders can fly, and we know how! Stay indoors, folks.
Hospital lures fishermen to ED
There are some things you expect to see when you walk into a hospital: an admitting desk, waiting areas full of people, security guards, bad art work, maybe a friendly greeter at the door (sorry, that’s the Walmart).
The main lobby at Adirondack Medical Center in Saranac Lake, N.Y., however, has something you might not expect: a display of fishing lures.
Each of the more than 100 lures on display originally showed up at the hospital’s emergency department attached to an arm, leg, nose, or lip – pretty much every body part possible, Gary Nye, a physician assistant in the ED, told newyorkupstate.com. He’s even removed lures from several patients’ penises and scrotums. “Usually alcohol has something to do with it,” he noted.
One individual came in with hooks from a lure stuck on both thumbs. He got one set of hooks stuck on one thumb, and as he tried to get it out, he ended up getting the lure’s other set of hooks caught on his other thumb. A nurse who has worked in the ED for 20 years said that alcohol may been involved.
Dr. Michael Pond, the hospital’s former medical director and the one who started the display in 1990, explained why the lures are now kept in a locked case. A number of years ago, when the display was less secure, “someone cut out and stole four to five antique lures out of the case. I mean, these were absolutely gorgeous and expensive lures – Pikie Minnows and [other] things. [They] were made out of wood and painted.”
As with so many fish stories, you should have seen the one that got away.
Inspiration really can come from anywhere
On the surface, a study detailing a new, potentially practice-changing method of converting type A blood to type O doesn’t seem disgusting, silly, or odd enough to make it into Livin’ on the MDedge. But when you dig a little deeper, you’ll see that the method involves a bacteria in the human microbiome.
Now you might be getting a bit suspicious. This is going to be another story about poop, you might be thinking.
And you’d be right!
But the real star of the show isn’t human poop. No, in this case, we owe this groundbreaking discovery to the humble beaver.
In an earlier study published in the ISME Journal, the same group of researchers from the University of British Columbia in Vancouver (of course they’re Canadian) analyzed the microbiomes of beavers to see just how they broke down the complex carbohydrates and glycoproteins found in wood. That was the catalyst that got the researchers thinking about the human microbiome and the problem of stripping red blood cells of their antigens.
Basically, just as the beaver breaks down wood with bacteria in their microbiome, the modified bacteria the researchers conjured up can be used to break down the A and B antigens of red blood cells, leaving a simple type O cell that can be transfused into any patient.
Rumors that all future blood transfusions are required by law to be accompanied by a playing of O Canada remain unsubstantiated.
Cockatoo cha-cha-cha
Humans love to dance. Whether it’s just a little bobbing back and forth or a full-on tango, spontaneous dancing is a universal expression of feeling and joy. However, feeling the rhythm is nearly unique to the human species. Not even our closest relatives in the animal kingdom, primates, have been observed busting a move to music.
So who are our ballroom brethren? Parrots, strangely enough. Parrots are nature’s great imitators, so how can we be sure they aren’t just mimicking (or mocking) their human owners’ movements?
Several studies have been conducted on a particularly funky cockatoo named Snowball. He’s a viral Internet sensation, and researchers have been watching him for the past decade as he stomps his feet and bangs his head to all kinds of music – he jams to everything from classic rock to modern pop. Snowball’s owner also assured scientists that her bird does not get his dance moves from her; Snowball is a unique choreographer.
A follow-up study about Snowball was recently published, in which the authors suggested the reason for spontaneous parrot dancing could be the strong auditory-motor connections that exist in parrot brains. They’re similar to humans, but not primates. They also detailed Snowball’s 14 distinct dance moves. Someone get that parrot on America’s Got Talent, ASAP.
It’s a bird, it’s a plane – oh no, it’s a spider
Arachnophobes, just skip this one. If you’re not unsettled by spiders yet, you’re about to be!
In case you didn’t know, spiders can fly. Or rather, they float (spiders with wings would just be straight-up horrifying).
Scientists (and fans of Charlotte’s Web) have known for centuries that spiders can turn into their own personal airships, but it wasn’t always clear how they do it. It was commonly believed that spider-flying, aka “ballooning,” was caused by the spider using its silk as a kind of kite, with the wind catching on the silk and bringing the spider along with it. That explanation, however, doesn’t account for the fact that spiders only balloon during light winds, which are rarely strong enough to carry a spider.
Two intrepid spider fans from the University of Bristol (England) think they have solved the mystery of the flying arachnids.
It turns out that spiders are able to sense the earth’s electric field and use that to soar around. They let loose some silk, which picks up a negative charge. This charge repels the negative charge of whatever they are standing on and can create enough force to launch them into the air. Spiders, those smart little buggers, can increase these charges by climbing onto twigs or grass. Plants rooted in the earth have a strong negative charge but stick up into the positively charged air.
All this fancy science-babble to say: Spiders can fly, and we know how! Stay indoors, folks.
Hospital lures fishermen to ED
There are some things you expect to see when you walk into a hospital: an admitting desk, waiting areas full of people, security guards, bad art work, maybe a friendly greeter at the door (sorry, that’s the Walmart).
The main lobby at Adirondack Medical Center in Saranac Lake, N.Y., however, has something you might not expect: a display of fishing lures.
Each of the more than 100 lures on display originally showed up at the hospital’s emergency department attached to an arm, leg, nose, or lip – pretty much every body part possible, Gary Nye, a physician assistant in the ED, told newyorkupstate.com. He’s even removed lures from several patients’ penises and scrotums. “Usually alcohol has something to do with it,” he noted.
One individual came in with hooks from a lure stuck on both thumbs. He got one set of hooks stuck on one thumb, and as he tried to get it out, he ended up getting the lure’s other set of hooks caught on his other thumb. A nurse who has worked in the ED for 20 years said that alcohol may been involved.
Dr. Michael Pond, the hospital’s former medical director and the one who started the display in 1990, explained why the lures are now kept in a locked case. A number of years ago, when the display was less secure, “someone cut out and stole four to five antique lures out of the case. I mean, these were absolutely gorgeous and expensive lures – Pikie Minnows and [other] things. [They] were made out of wood and painted.”
As with so many fish stories, you should have seen the one that got away.
Inspiration really can come from anywhere
On the surface, a study detailing a new, potentially practice-changing method of converting type A blood to type O doesn’t seem disgusting, silly, or odd enough to make it into Livin’ on the MDedge. But when you dig a little deeper, you’ll see that the method involves a bacteria in the human microbiome.
Now you might be getting a bit suspicious. This is going to be another story about poop, you might be thinking.
And you’d be right!
But the real star of the show isn’t human poop. No, in this case, we owe this groundbreaking discovery to the humble beaver.
In an earlier study published in the ISME Journal, the same group of researchers from the University of British Columbia in Vancouver (of course they’re Canadian) analyzed the microbiomes of beavers to see just how they broke down the complex carbohydrates and glycoproteins found in wood. That was the catalyst that got the researchers thinking about the human microbiome and the problem of stripping red blood cells of their antigens.
Basically, just as the beaver breaks down wood with bacteria in their microbiome, the modified bacteria the researchers conjured up can be used to break down the A and B antigens of red blood cells, leaving a simple type O cell that can be transfused into any patient.
Rumors that all future blood transfusions are required by law to be accompanied by a playing of O Canada remain unsubstantiated.
Consider cutaneous endometriosis in women with umbilical lesions
according to Liza Raffi of the University of Southern California, Los Angeles, and associates.
The report, published in the International Journal of Women’s Dermatology, detailed a case of a woman aged 41 years who presented with a 5-month history of a painful firm subcutaneous nodule in the umbilicus and flares of pain during menstrual periods. Her past history indicated a missed miscarriage (removed by dilation and curettage) and laparoscopic left salpingectomy for a ruptured ectopic pregnancy.
At presentation, the woman reported undergoing fertility treatments including subcutaneous injections of follitropin beta and choriogonadotropin alfa.
Because of the patient’s history of salpingectomy and painful menstrual periods, her physicians suspected cutaneous endometriosis. An ultrasound was performed to rule out fistula, and then a punch biopsy of the nodule was performed. The biopsy showed endometrial glands with encompassing fibrotic stroma, which was consistent with cutaneous endometriosis, likely transplanted during the laparoscopic port site entry during salpingectomy.
The patient chose to undergo surgery for excision of the nodule, declining hormonal therapy because she was undergoing fertility treatment.
“The differential diagnosis of umbilical lesions with similar presentation includes keloid, dermatofibroma, dermatofibrosarcoma protuberans, and cutaneous metastasis of cancer,” the investigators wrote. “Ultimately, patients should be referred to obstetrics & gynecology if they describe classic symptoms including pain with menses, dyspareunia, and infertility and wish to explore diagnostic and therapeutic options.”
Ms. Raffi and associates reported they had no conflicts of interest. There was no external funding.
SOURCE: Raffi L et al. Int J Womens Dermatol. 2019 Jul 2. doi: 10.1016/j.ijwd.2019.06.025.
according to Liza Raffi of the University of Southern California, Los Angeles, and associates.
The report, published in the International Journal of Women’s Dermatology, detailed a case of a woman aged 41 years who presented with a 5-month history of a painful firm subcutaneous nodule in the umbilicus and flares of pain during menstrual periods. Her past history indicated a missed miscarriage (removed by dilation and curettage) and laparoscopic left salpingectomy for a ruptured ectopic pregnancy.
At presentation, the woman reported undergoing fertility treatments including subcutaneous injections of follitropin beta and choriogonadotropin alfa.
Because of the patient’s history of salpingectomy and painful menstrual periods, her physicians suspected cutaneous endometriosis. An ultrasound was performed to rule out fistula, and then a punch biopsy of the nodule was performed. The biopsy showed endometrial glands with encompassing fibrotic stroma, which was consistent with cutaneous endometriosis, likely transplanted during the laparoscopic port site entry during salpingectomy.
The patient chose to undergo surgery for excision of the nodule, declining hormonal therapy because she was undergoing fertility treatment.
“The differential diagnosis of umbilical lesions with similar presentation includes keloid, dermatofibroma, dermatofibrosarcoma protuberans, and cutaneous metastasis of cancer,” the investigators wrote. “Ultimately, patients should be referred to obstetrics & gynecology if they describe classic symptoms including pain with menses, dyspareunia, and infertility and wish to explore diagnostic and therapeutic options.”
Ms. Raffi and associates reported they had no conflicts of interest. There was no external funding.
SOURCE: Raffi L et al. Int J Womens Dermatol. 2019 Jul 2. doi: 10.1016/j.ijwd.2019.06.025.
according to Liza Raffi of the University of Southern California, Los Angeles, and associates.
The report, published in the International Journal of Women’s Dermatology, detailed a case of a woman aged 41 years who presented with a 5-month history of a painful firm subcutaneous nodule in the umbilicus and flares of pain during menstrual periods. Her past history indicated a missed miscarriage (removed by dilation and curettage) and laparoscopic left salpingectomy for a ruptured ectopic pregnancy.
At presentation, the woman reported undergoing fertility treatments including subcutaneous injections of follitropin beta and choriogonadotropin alfa.
Because of the patient’s history of salpingectomy and painful menstrual periods, her physicians suspected cutaneous endometriosis. An ultrasound was performed to rule out fistula, and then a punch biopsy of the nodule was performed. The biopsy showed endometrial glands with encompassing fibrotic stroma, which was consistent with cutaneous endometriosis, likely transplanted during the laparoscopic port site entry during salpingectomy.
The patient chose to undergo surgery for excision of the nodule, declining hormonal therapy because she was undergoing fertility treatment.
“The differential diagnosis of umbilical lesions with similar presentation includes keloid, dermatofibroma, dermatofibrosarcoma protuberans, and cutaneous metastasis of cancer,” the investigators wrote. “Ultimately, patients should be referred to obstetrics & gynecology if they describe classic symptoms including pain with menses, dyspareunia, and infertility and wish to explore diagnostic and therapeutic options.”
Ms. Raffi and associates reported they had no conflicts of interest. There was no external funding.
SOURCE: Raffi L et al. Int J Womens Dermatol. 2019 Jul 2. doi: 10.1016/j.ijwd.2019.06.025.
FROM THE INTERNATIONAL JOURNAL OF WOMEN’S DERMATOLOGY
Self-harm with bupropion linked to greater risk compared to SSRIs
Adolescents who attempt self-harm using bupropion are at a significantly higher risk of serious morbidity and poor outcomes, compared with those who attempt self-harm with selective serotonin reuptake inhibitors (SSRIs), according to Adam Overberg, PharmD, of the Indiana Poison Center in Indianapolis and associates.
In a study published in Pediatrics, the researchers analyzed 30,026 cases that were coded as “suspected suicide” and were reported to the National Poison Data System between June 2013 and December 2017. All cases were in adolescents aged 10-19 years. A total of 3,504 cases were exposures to bupropion; the rest were exposures to SSRIs.
Cases involving SSRIs were significantly more likely to result in either minor or no outcomes, compared with bupropion (68.0% vs 33.2%); cases resulting in moderate or major outcomes were much more likely to involve bupropion, compared with SSRIs (58.1% vs 19.0%). Among the 10 most common effects in cases with a moderate or major outcome, bupropion was more likely to cause tachycardia (83.7% vs. 59.9%), vomiting (24.8% vs. 20.6%), cardiac conduction disturbances (20.0% vs. 17.1%), agitation (20.2% vs. 11.7%), seizures (27.0% vs. 8.5%), and hallucinations (28.6% vs. 4.3%). Cases involving SSRIs were more likely to cause hypertension (25.3% vs. 17.6%). Eight deaths were reported in the study population; all were caused by bupropion ingestion.
Medical therapies that were more common with bupropion overdose included intubation (4.9% vs. 0.3%), vasopressor use (1.1% vs. 0.2%), benzodiazepine administration (34.2% vs. 5.4%), supplemental oxygen requirement (8.2% vs. 0.8%), and CPR (0.5% vs. 0.01%); three patients in the bupropion group required extracorporeal membrane oxygenation, compared with none in the SSRI group.
“Suicidal ingestions are increasing steadily, as are the numbers of adolescents treated with medication for depression. In light of bupropion’s disproportionately significant morbidity and mortality risk, it would be prudent for practitioners to avoid the use of this medication in adolescents that are at risk for self-harm,” the investigators concluded.
The study investigators reported that there were no conflicts of interest.
SOURCE: Overberg A et al. Pediatrics. 2019 Jul 5. doi: 10.1542/peds.2018-3295.
Adolescents who attempt self-harm using bupropion are at a significantly higher risk of serious morbidity and poor outcomes, compared with those who attempt self-harm with selective serotonin reuptake inhibitors (SSRIs), according to Adam Overberg, PharmD, of the Indiana Poison Center in Indianapolis and associates.
In a study published in Pediatrics, the researchers analyzed 30,026 cases that were coded as “suspected suicide” and were reported to the National Poison Data System between June 2013 and December 2017. All cases were in adolescents aged 10-19 years. A total of 3,504 cases were exposures to bupropion; the rest were exposures to SSRIs.
Cases involving SSRIs were significantly more likely to result in either minor or no outcomes, compared with bupropion (68.0% vs 33.2%); cases resulting in moderate or major outcomes were much more likely to involve bupropion, compared with SSRIs (58.1% vs 19.0%). Among the 10 most common effects in cases with a moderate or major outcome, bupropion was more likely to cause tachycardia (83.7% vs. 59.9%), vomiting (24.8% vs. 20.6%), cardiac conduction disturbances (20.0% vs. 17.1%), agitation (20.2% vs. 11.7%), seizures (27.0% vs. 8.5%), and hallucinations (28.6% vs. 4.3%). Cases involving SSRIs were more likely to cause hypertension (25.3% vs. 17.6%). Eight deaths were reported in the study population; all were caused by bupropion ingestion.
Medical therapies that were more common with bupropion overdose included intubation (4.9% vs. 0.3%), vasopressor use (1.1% vs. 0.2%), benzodiazepine administration (34.2% vs. 5.4%), supplemental oxygen requirement (8.2% vs. 0.8%), and CPR (0.5% vs. 0.01%); three patients in the bupropion group required extracorporeal membrane oxygenation, compared with none in the SSRI group.
“Suicidal ingestions are increasing steadily, as are the numbers of adolescents treated with medication for depression. In light of bupropion’s disproportionately significant morbidity and mortality risk, it would be prudent for practitioners to avoid the use of this medication in adolescents that are at risk for self-harm,” the investigators concluded.
The study investigators reported that there were no conflicts of interest.
SOURCE: Overberg A et al. Pediatrics. 2019 Jul 5. doi: 10.1542/peds.2018-3295.
Adolescents who attempt self-harm using bupropion are at a significantly higher risk of serious morbidity and poor outcomes, compared with those who attempt self-harm with selective serotonin reuptake inhibitors (SSRIs), according to Adam Overberg, PharmD, of the Indiana Poison Center in Indianapolis and associates.
In a study published in Pediatrics, the researchers analyzed 30,026 cases that were coded as “suspected suicide” and were reported to the National Poison Data System between June 2013 and December 2017. All cases were in adolescents aged 10-19 years. A total of 3,504 cases were exposures to bupropion; the rest were exposures to SSRIs.
Cases involving SSRIs were significantly more likely to result in either minor or no outcomes, compared with bupropion (68.0% vs 33.2%); cases resulting in moderate or major outcomes were much more likely to involve bupropion, compared with SSRIs (58.1% vs 19.0%). Among the 10 most common effects in cases with a moderate or major outcome, bupropion was more likely to cause tachycardia (83.7% vs. 59.9%), vomiting (24.8% vs. 20.6%), cardiac conduction disturbances (20.0% vs. 17.1%), agitation (20.2% vs. 11.7%), seizures (27.0% vs. 8.5%), and hallucinations (28.6% vs. 4.3%). Cases involving SSRIs were more likely to cause hypertension (25.3% vs. 17.6%). Eight deaths were reported in the study population; all were caused by bupropion ingestion.
Medical therapies that were more common with bupropion overdose included intubation (4.9% vs. 0.3%), vasopressor use (1.1% vs. 0.2%), benzodiazepine administration (34.2% vs. 5.4%), supplemental oxygen requirement (8.2% vs. 0.8%), and CPR (0.5% vs. 0.01%); three patients in the bupropion group required extracorporeal membrane oxygenation, compared with none in the SSRI group.
“Suicidal ingestions are increasing steadily, as are the numbers of adolescents treated with medication for depression. In light of bupropion’s disproportionately significant morbidity and mortality risk, it would be prudent for practitioners to avoid the use of this medication in adolescents that are at risk for self-harm,” the investigators concluded.
The study investigators reported that there were no conflicts of interest.
SOURCE: Overberg A et al. Pediatrics. 2019 Jul 5. doi: 10.1542/peds.2018-3295.
FROM PEDIATRICS
Flying acid zombies, poster face-lifts, and feces of champions
The flying dead
Just when you thought cicada infestations couldn’t get worse – the cicadas are now zombies on an acid trip.
West Virginia University researchers recently discovered that a fungus called Massopora, which has compounds similar to those found in psychedelic mushrooms, can infect cicadas and cause seriously weird behavior.
How weird, you ask? Well, male cicadas try to mate with everything they encounter, even though the fungus has eaten away their limbs … and their genitals. Talk about a bad trip.
It gets worse. These zombie-like cicadas are flying around and exposing their healthy brethren to the fungus. So, now we have to worry about potentially billions of these buggers becoming rotting, flying, hypersexual machines.
Makes a person really want to stay inside for the whole summer, perhaps in a fortified bunker. Just in case.
Also, for the curious: One of the study’s authors concedes that if a person were “motivated enough,” they might be able to get high off the cicada fungus. Not interested in finding out exactly how many cicadas you’d have to crunch on before you start tasting colors?
Poster do-over
It’s time to get ready for a revolution – and just in time for 4th of July. No, we’re not redeclaring independence from Britain. It’s something much, much more radical, at least to the scientific community.
Get ready for … the redesign of the science poster.
Mike Morrison, a doctoral student in psychology, has proposed a new way to present information at meetings that breathes new life into the tired poster design. While fascinating insights could be held on a poster, the reality of meetings and conferences is that people often skim over the posters they see, barely registering the information.
Morrison is taking advantage of the ever-present smartphone to ramp up the classic science poster to a new level. He proposes a format where the key research finding is smack in the middle, in big, readable language. Accompanying this is a QR code you can scan, which would take you to a page with the full details of the study.
Morrison tweeted out his idea, and it spread quickly through the scientific community, gaining traction from younger scientists and students who love the idea.
We’re in the age of remakes now – in which classics are reinvented for a new audience. It’s time the science poster got a face-lift, too.
Running a marathon, one Veillonella at a time
What’s the difference between an elite athlete and a person who’s out of juice after running for 30 seconds?
Well, many things, we’re sure. A proper diet, rigorous training, not spending 12 hours a day sitting behind a computer screen. But just to add insult to injury, according to a study published in Nature Medicine, athletes even poop better than us normal people.
That may require a bit of explanation. A group of researchers from Harvard University, Boston, analyzed stool samples from elite marathon runners before and just after they participated in the 2015 Boston Marathon. They found that, following the race, the athletes had significantly higher amounts of Veillonella in their microbiota. This bacteria breaks down lactic acid, which is made during intense exercise and causes muscle fatigue and stress.
Naturally, the next step was to take that bacteria, feed it to mice, then get them running on a treadmill.
While not every mouse fed Veillonella saw increased performance, on average, mice that received the bacteria saw a 13% improvement over their non–Veillonella enhanced friends.
The researchers noted that this sort of probiotic treatment could be useful to patients with metabolic diseases, such as diabetes. Plus, there’s the obvious benefit to athletes. We look forward to hearing advertisements swearing by Veillonella-infused Wheaties, the true breakfast of champions.
Put a little boredom in your life
Is your job an endless, soul-sucking vortex of dreariness? Do you stare at the wall for hours at a time while you’re at work, wishing you had something better to do? Do you look forward to leaving early to go to the dentist? [Editor query: What does this have to do with health care? LOTME: You’ll see. We’re building dramatic tension.]
Did you answer yes to any of these questions? Way to go! You’ve taken the first step on the road to creativity. [Still waiting. We’re almost there.]
A recent study examined the effects of boredom by assigning people to either a really boring task – sorting a bowl of red and green beans by color for 30 minutes using only one hand – or a nonboring art project using paper, glue, and, of course, beans. [What’s with the beans? It’s not our fault they used beans.]
The next task was the same for both groups: Come up with some reasons for being late for work and think of ideas for a new product by a hypothetical company. The answers were graded on their uniqueness, and the bean-sorting group had more creative ideas than did the art-project group.
The point is, ladies and gentlemen, that boredom is good. Boredom is right. Boredom works. [A Gordon Gekko reference? Couldn’t you find something from this century? No.]
By now you’re probably wondering: “But how can I get one of those really boring jobs? After all, I’m a doctor. I heal the sick and care for the needy. My work is way too interesting to inspire true creativity.” Have you ever considered writing a medical humor column?
[Note to readers: We’ve pulled the staff away from their building blocks and crayons and given them a timeout. Hopefully things will be a little better by next week.]
The flying dead
Just when you thought cicada infestations couldn’t get worse – the cicadas are now zombies on an acid trip.
West Virginia University researchers recently discovered that a fungus called Massopora, which has compounds similar to those found in psychedelic mushrooms, can infect cicadas and cause seriously weird behavior.
How weird, you ask? Well, male cicadas try to mate with everything they encounter, even though the fungus has eaten away their limbs … and their genitals. Talk about a bad trip.
It gets worse. These zombie-like cicadas are flying around and exposing their healthy brethren to the fungus. So, now we have to worry about potentially billions of these buggers becoming rotting, flying, hypersexual machines.
Makes a person really want to stay inside for the whole summer, perhaps in a fortified bunker. Just in case.
Also, for the curious: One of the study’s authors concedes that if a person were “motivated enough,” they might be able to get high off the cicada fungus. Not interested in finding out exactly how many cicadas you’d have to crunch on before you start tasting colors?
Poster do-over
It’s time to get ready for a revolution – and just in time for 4th of July. No, we’re not redeclaring independence from Britain. It’s something much, much more radical, at least to the scientific community.
Get ready for … the redesign of the science poster.
Mike Morrison, a doctoral student in psychology, has proposed a new way to present information at meetings that breathes new life into the tired poster design. While fascinating insights could be held on a poster, the reality of meetings and conferences is that people often skim over the posters they see, barely registering the information.
Morrison is taking advantage of the ever-present smartphone to ramp up the classic science poster to a new level. He proposes a format where the key research finding is smack in the middle, in big, readable language. Accompanying this is a QR code you can scan, which would take you to a page with the full details of the study.
Morrison tweeted out his idea, and it spread quickly through the scientific community, gaining traction from younger scientists and students who love the idea.
We’re in the age of remakes now – in which classics are reinvented for a new audience. It’s time the science poster got a face-lift, too.
Running a marathon, one Veillonella at a time
What’s the difference between an elite athlete and a person who’s out of juice after running for 30 seconds?
Well, many things, we’re sure. A proper diet, rigorous training, not spending 12 hours a day sitting behind a computer screen. But just to add insult to injury, according to a study published in Nature Medicine, athletes even poop better than us normal people.
That may require a bit of explanation. A group of researchers from Harvard University, Boston, analyzed stool samples from elite marathon runners before and just after they participated in the 2015 Boston Marathon. They found that, following the race, the athletes had significantly higher amounts of Veillonella in their microbiota. This bacteria breaks down lactic acid, which is made during intense exercise and causes muscle fatigue and stress.
Naturally, the next step was to take that bacteria, feed it to mice, then get them running on a treadmill.
While not every mouse fed Veillonella saw increased performance, on average, mice that received the bacteria saw a 13% improvement over their non–Veillonella enhanced friends.
The researchers noted that this sort of probiotic treatment could be useful to patients with metabolic diseases, such as diabetes. Plus, there’s the obvious benefit to athletes. We look forward to hearing advertisements swearing by Veillonella-infused Wheaties, the true breakfast of champions.
Put a little boredom in your life
Is your job an endless, soul-sucking vortex of dreariness? Do you stare at the wall for hours at a time while you’re at work, wishing you had something better to do? Do you look forward to leaving early to go to the dentist? [Editor query: What does this have to do with health care? LOTME: You’ll see. We’re building dramatic tension.]
Did you answer yes to any of these questions? Way to go! You’ve taken the first step on the road to creativity. [Still waiting. We’re almost there.]
A recent study examined the effects of boredom by assigning people to either a really boring task – sorting a bowl of red and green beans by color for 30 minutes using only one hand – or a nonboring art project using paper, glue, and, of course, beans. [What’s with the beans? It’s not our fault they used beans.]
The next task was the same for both groups: Come up with some reasons for being late for work and think of ideas for a new product by a hypothetical company. The answers were graded on their uniqueness, and the bean-sorting group had more creative ideas than did the art-project group.
The point is, ladies and gentlemen, that boredom is good. Boredom is right. Boredom works. [A Gordon Gekko reference? Couldn’t you find something from this century? No.]
By now you’re probably wondering: “But how can I get one of those really boring jobs? After all, I’m a doctor. I heal the sick and care for the needy. My work is way too interesting to inspire true creativity.” Have you ever considered writing a medical humor column?
[Note to readers: We’ve pulled the staff away from their building blocks and crayons and given them a timeout. Hopefully things will be a little better by next week.]
The flying dead
Just when you thought cicada infestations couldn’t get worse – the cicadas are now zombies on an acid trip.
West Virginia University researchers recently discovered that a fungus called Massopora, which has compounds similar to those found in psychedelic mushrooms, can infect cicadas and cause seriously weird behavior.
How weird, you ask? Well, male cicadas try to mate with everything they encounter, even though the fungus has eaten away their limbs … and their genitals. Talk about a bad trip.
It gets worse. These zombie-like cicadas are flying around and exposing their healthy brethren to the fungus. So, now we have to worry about potentially billions of these buggers becoming rotting, flying, hypersexual machines.
Makes a person really want to stay inside for the whole summer, perhaps in a fortified bunker. Just in case.
Also, for the curious: One of the study’s authors concedes that if a person were “motivated enough,” they might be able to get high off the cicada fungus. Not interested in finding out exactly how many cicadas you’d have to crunch on before you start tasting colors?
Poster do-over
It’s time to get ready for a revolution – and just in time for 4th of July. No, we’re not redeclaring independence from Britain. It’s something much, much more radical, at least to the scientific community.
Get ready for … the redesign of the science poster.
Mike Morrison, a doctoral student in psychology, has proposed a new way to present information at meetings that breathes new life into the tired poster design. While fascinating insights could be held on a poster, the reality of meetings and conferences is that people often skim over the posters they see, barely registering the information.
Morrison is taking advantage of the ever-present smartphone to ramp up the classic science poster to a new level. He proposes a format where the key research finding is smack in the middle, in big, readable language. Accompanying this is a QR code you can scan, which would take you to a page with the full details of the study.
Morrison tweeted out his idea, and it spread quickly through the scientific community, gaining traction from younger scientists and students who love the idea.
We’re in the age of remakes now – in which classics are reinvented for a new audience. It’s time the science poster got a face-lift, too.
Running a marathon, one Veillonella at a time
What’s the difference between an elite athlete and a person who’s out of juice after running for 30 seconds?
Well, many things, we’re sure. A proper diet, rigorous training, not spending 12 hours a day sitting behind a computer screen. But just to add insult to injury, according to a study published in Nature Medicine, athletes even poop better than us normal people.
That may require a bit of explanation. A group of researchers from Harvard University, Boston, analyzed stool samples from elite marathon runners before and just after they participated in the 2015 Boston Marathon. They found that, following the race, the athletes had significantly higher amounts of Veillonella in their microbiota. This bacteria breaks down lactic acid, which is made during intense exercise and causes muscle fatigue and stress.
Naturally, the next step was to take that bacteria, feed it to mice, then get them running on a treadmill.
While not every mouse fed Veillonella saw increased performance, on average, mice that received the bacteria saw a 13% improvement over their non–Veillonella enhanced friends.
The researchers noted that this sort of probiotic treatment could be useful to patients with metabolic diseases, such as diabetes. Plus, there’s the obvious benefit to athletes. We look forward to hearing advertisements swearing by Veillonella-infused Wheaties, the true breakfast of champions.
Put a little boredom in your life
Is your job an endless, soul-sucking vortex of dreariness? Do you stare at the wall for hours at a time while you’re at work, wishing you had something better to do? Do you look forward to leaving early to go to the dentist? [Editor query: What does this have to do with health care? LOTME: You’ll see. We’re building dramatic tension.]
Did you answer yes to any of these questions? Way to go! You’ve taken the first step on the road to creativity. [Still waiting. We’re almost there.]
A recent study examined the effects of boredom by assigning people to either a really boring task – sorting a bowl of red and green beans by color for 30 minutes using only one hand – or a nonboring art project using paper, glue, and, of course, beans. [What’s with the beans? It’s not our fault they used beans.]
The next task was the same for both groups: Come up with some reasons for being late for work and think of ideas for a new product by a hypothetical company. The answers were graded on their uniqueness, and the bean-sorting group had more creative ideas than did the art-project group.
The point is, ladies and gentlemen, that boredom is good. Boredom is right. Boredom works. [A Gordon Gekko reference? Couldn’t you find something from this century? No.]
By now you’re probably wondering: “But how can I get one of those really boring jobs? After all, I’m a doctor. I heal the sick and care for the needy. My work is way too interesting to inspire true creativity.” Have you ever considered writing a medical humor column?
[Note to readers: We’ve pulled the staff away from their building blocks and crayons and given them a timeout. Hopefully things will be a little better by next week.]
FDA issues warning on insulin pump cybersecurity weakness
The Food and Drug Administration has issued a warning to patients and health care providers that a pair of Medtronic insulin pumps are being recalled because of potential cybersecurity risks, according to a press release.
The affected devices are the MiniMed 508 and MiniMed Paradigm series insulin pumps, which wirelessly connect to both the patient’s blood glucose meter and continuous glucose monitoring system. A remote controller and CareLink USB – a thumb-sized wireless device that plugs into a computer – are used to operate the devices; the remote controller sends insulin dosing commands to the pump and the CareLink USB can be used to download and share data with the patient’s health care provider.
The potential risk involves the wireless communication between the pumps and related devices such as the blood glucose meter and remote controller. The FDA has identified a cybersecurity vulnerability within the insulin pumps, and is concerned that a third party could connect to the device and change the pump’s settings. Insulin could be given in excess, causing hypoglycemia, or stopped, causing hyperglycemia or diabetic ketoacidosis.
Medtronic has identified 4,000 patients in the United States who are affected by the security weakness. Because the company is unable to adequately update or patch the device to remove the weakness, the FDA is working to ensure that Medtronic addresses the issue in any way possible, including helping patients with affected pumps switch to newer models.
“While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed is significant. The safety communication issued today contains recommendations for what actions patients and health care providers should take to avoid the risk this vulnerability could pose,” said Suzanne Schwartz, MD, MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation.
Find the full press release on the FDA website.
The Food and Drug Administration has issued a warning to patients and health care providers that a pair of Medtronic insulin pumps are being recalled because of potential cybersecurity risks, according to a press release.
The affected devices are the MiniMed 508 and MiniMed Paradigm series insulin pumps, which wirelessly connect to both the patient’s blood glucose meter and continuous glucose monitoring system. A remote controller and CareLink USB – a thumb-sized wireless device that plugs into a computer – are used to operate the devices; the remote controller sends insulin dosing commands to the pump and the CareLink USB can be used to download and share data with the patient’s health care provider.
The potential risk involves the wireless communication between the pumps and related devices such as the blood glucose meter and remote controller. The FDA has identified a cybersecurity vulnerability within the insulin pumps, and is concerned that a third party could connect to the device and change the pump’s settings. Insulin could be given in excess, causing hypoglycemia, or stopped, causing hyperglycemia or diabetic ketoacidosis.
Medtronic has identified 4,000 patients in the United States who are affected by the security weakness. Because the company is unable to adequately update or patch the device to remove the weakness, the FDA is working to ensure that Medtronic addresses the issue in any way possible, including helping patients with affected pumps switch to newer models.
“While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed is significant. The safety communication issued today contains recommendations for what actions patients and health care providers should take to avoid the risk this vulnerability could pose,” said Suzanne Schwartz, MD, MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation.
Find the full press release on the FDA website.
The Food and Drug Administration has issued a warning to patients and health care providers that a pair of Medtronic insulin pumps are being recalled because of potential cybersecurity risks, according to a press release.
The affected devices are the MiniMed 508 and MiniMed Paradigm series insulin pumps, which wirelessly connect to both the patient’s blood glucose meter and continuous glucose monitoring system. A remote controller and CareLink USB – a thumb-sized wireless device that plugs into a computer – are used to operate the devices; the remote controller sends insulin dosing commands to the pump and the CareLink USB can be used to download and share data with the patient’s health care provider.
The potential risk involves the wireless communication between the pumps and related devices such as the blood glucose meter and remote controller. The FDA has identified a cybersecurity vulnerability within the insulin pumps, and is concerned that a third party could connect to the device and change the pump’s settings. Insulin could be given in excess, causing hypoglycemia, or stopped, causing hyperglycemia or diabetic ketoacidosis.
Medtronic has identified 4,000 patients in the United States who are affected by the security weakness. Because the company is unable to adequately update or patch the device to remove the weakness, the FDA is working to ensure that Medtronic addresses the issue in any way possible, including helping patients with affected pumps switch to newer models.
“While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm if such a vulnerability were left unaddressed is significant. The safety communication issued today contains recommendations for what actions patients and health care providers should take to avoid the risk this vulnerability could pose,” said Suzanne Schwartz, MD, MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation.
Find the full press release on the FDA website.
FDA expands Doptelet approval to ITP patients with thrombocytopenia
The Food and Drug Administration has approved a supplemental New Drug Application expanding the indication of avatrombopag (Doptelet) to include treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous therapy, according to Dova Pharmaceuticals.
FDA approval was based on results of a phase 3 trial in which a majority of patients who received avatrombopag achieved a platelet count of at least 50,000 per mcg after 8 days of therapy. In addition, efficacy was superior to patients in the placebo group in the maintenance of platelet counts during the 6-month treatment period.
Avatrombopag – an oral, thrombopoietin receptor agonist administered with food – was previously indicated for the treatment of chronic liver disease in adult patients who are scheduled to undergo a procedure. The most common adverse reactions in patients with ITP include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Find the full press release on the Dova Pharmaceuticals website.
The Food and Drug Administration has approved a supplemental New Drug Application expanding the indication of avatrombopag (Doptelet) to include treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous therapy, according to Dova Pharmaceuticals.
FDA approval was based on results of a phase 3 trial in which a majority of patients who received avatrombopag achieved a platelet count of at least 50,000 per mcg after 8 days of therapy. In addition, efficacy was superior to patients in the placebo group in the maintenance of platelet counts during the 6-month treatment period.
Avatrombopag – an oral, thrombopoietin receptor agonist administered with food – was previously indicated for the treatment of chronic liver disease in adult patients who are scheduled to undergo a procedure. The most common adverse reactions in patients with ITP include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Find the full press release on the Dova Pharmaceuticals website.
The Food and Drug Administration has approved a supplemental New Drug Application expanding the indication of avatrombopag (Doptelet) to include treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous therapy, according to Dova Pharmaceuticals.
FDA approval was based on results of a phase 3 trial in which a majority of patients who received avatrombopag achieved a platelet count of at least 50,000 per mcg after 8 days of therapy. In addition, efficacy was superior to patients in the placebo group in the maintenance of platelet counts during the 6-month treatment period.
Avatrombopag – an oral, thrombopoietin receptor agonist administered with food – was previously indicated for the treatment of chronic liver disease in adult patients who are scheduled to undergo a procedure. The most common adverse reactions in patients with ITP include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Find the full press release on the Dova Pharmaceuticals website.
More than half of U.S. adults have never received HIV screening
Despite a 2006 recommendation by the Centers for Disease Control and Prevention recommending universal screening for HIV, less than half of U.S. adults have ever been tested for the disease, a new study found.
“HIV screening is a critical entry point to a range of HIV prevention and treatment options. For persons at ongoing risk for HIV infection exposure, annual screening also offers the opportunity to discuss options to reduce risk, including HIV preexposure prophylaxis,” Marc A. Pitasi, MPH, and investigators from the CDC wrote in the Morbidity and Mortality Weekly Report.
The CDC investigators analyzed data collected from the Behavioral Risk Factor Surveillance System in 2016-2017 to assess the percentage of adults screened for HIV ever and in the past year across the entirety of the United States, in 50 local jurisdictions where the majority of new U.S. HIV cases occur, and in seven states with a disproportionately high rate of HIV in rural populations.
The rate of ever testing was 38.9% across the entire country, 46.9% in the 50 local jurisdictions, and 35.5% in the seven states. The percentage of adults who had undergone HIV screening in the past year was significantly smaller at 10.1% across the entire country, 14.5% in the 50 local jurisdictions, and 9.3% in the seven states. This improved to 29.2%, 34.3%, and 26.2%, respectively, in adults who were tested in the past year who were also at risk for the disease.
The rate of ever testing varied widely among the 50 jurisdictions, ranging from 36.5% in Maricopa County, Ariz., to 70.7% in Washington, D.C. However, in addition to D.C., only Baltimore, Bronx County (N.Y.), and New York County reached or exceeded 60% coverage. Bronx County also had the highest rate of HIV screening in the past year at 31.3%, while Alameda County, Calif., had the lowest rate at 8.1%.
Of the seven states (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina), Mississippi had the highest overall ever-testing rate at 40.2%, and Oklahoma had the lowest at 29.7%. People living in rural areas in those states were less likely to have ever been tested (32.1%) than those living in urban areas (37.2%). The difference between rural and urban areas increased for people at risk for HIV who had been screened in the past year, with 18.4% and 29.0%, respectively, reporting undergoing screening.
“These data provide a baseline from which to measure changes in screening in these jurisdictions and other parts of the United States over time. To achieve national goals and end the HIV epidemic in the United States, innovative and novel screening approaches might be needed to reach segments of the population that have never been tested for HIV,” the investigators concluded.
The investigators reported no conflicts of interest.
SOURCE: Pitasi MA et al. MMWR Morb Mortal Wkly Rep. 2019;68:561-7.
Despite a 2006 recommendation by the Centers for Disease Control and Prevention recommending universal screening for HIV, less than half of U.S. adults have ever been tested for the disease, a new study found.
“HIV screening is a critical entry point to a range of HIV prevention and treatment options. For persons at ongoing risk for HIV infection exposure, annual screening also offers the opportunity to discuss options to reduce risk, including HIV preexposure prophylaxis,” Marc A. Pitasi, MPH, and investigators from the CDC wrote in the Morbidity and Mortality Weekly Report.
The CDC investigators analyzed data collected from the Behavioral Risk Factor Surveillance System in 2016-2017 to assess the percentage of adults screened for HIV ever and in the past year across the entirety of the United States, in 50 local jurisdictions where the majority of new U.S. HIV cases occur, and in seven states with a disproportionately high rate of HIV in rural populations.
The rate of ever testing was 38.9% across the entire country, 46.9% in the 50 local jurisdictions, and 35.5% in the seven states. The percentage of adults who had undergone HIV screening in the past year was significantly smaller at 10.1% across the entire country, 14.5% in the 50 local jurisdictions, and 9.3% in the seven states. This improved to 29.2%, 34.3%, and 26.2%, respectively, in adults who were tested in the past year who were also at risk for the disease.
The rate of ever testing varied widely among the 50 jurisdictions, ranging from 36.5% in Maricopa County, Ariz., to 70.7% in Washington, D.C. However, in addition to D.C., only Baltimore, Bronx County (N.Y.), and New York County reached or exceeded 60% coverage. Bronx County also had the highest rate of HIV screening in the past year at 31.3%, while Alameda County, Calif., had the lowest rate at 8.1%.
Of the seven states (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina), Mississippi had the highest overall ever-testing rate at 40.2%, and Oklahoma had the lowest at 29.7%. People living in rural areas in those states were less likely to have ever been tested (32.1%) than those living in urban areas (37.2%). The difference between rural and urban areas increased for people at risk for HIV who had been screened in the past year, with 18.4% and 29.0%, respectively, reporting undergoing screening.
“These data provide a baseline from which to measure changes in screening in these jurisdictions and other parts of the United States over time. To achieve national goals and end the HIV epidemic in the United States, innovative and novel screening approaches might be needed to reach segments of the population that have never been tested for HIV,” the investigators concluded.
The investigators reported no conflicts of interest.
SOURCE: Pitasi MA et al. MMWR Morb Mortal Wkly Rep. 2019;68:561-7.
Despite a 2006 recommendation by the Centers for Disease Control and Prevention recommending universal screening for HIV, less than half of U.S. adults have ever been tested for the disease, a new study found.
“HIV screening is a critical entry point to a range of HIV prevention and treatment options. For persons at ongoing risk for HIV infection exposure, annual screening also offers the opportunity to discuss options to reduce risk, including HIV preexposure prophylaxis,” Marc A. Pitasi, MPH, and investigators from the CDC wrote in the Morbidity and Mortality Weekly Report.
The CDC investigators analyzed data collected from the Behavioral Risk Factor Surveillance System in 2016-2017 to assess the percentage of adults screened for HIV ever and in the past year across the entirety of the United States, in 50 local jurisdictions where the majority of new U.S. HIV cases occur, and in seven states with a disproportionately high rate of HIV in rural populations.
The rate of ever testing was 38.9% across the entire country, 46.9% in the 50 local jurisdictions, and 35.5% in the seven states. The percentage of adults who had undergone HIV screening in the past year was significantly smaller at 10.1% across the entire country, 14.5% in the 50 local jurisdictions, and 9.3% in the seven states. This improved to 29.2%, 34.3%, and 26.2%, respectively, in adults who were tested in the past year who were also at risk for the disease.
The rate of ever testing varied widely among the 50 jurisdictions, ranging from 36.5% in Maricopa County, Ariz., to 70.7% in Washington, D.C. However, in addition to D.C., only Baltimore, Bronx County (N.Y.), and New York County reached or exceeded 60% coverage. Bronx County also had the highest rate of HIV screening in the past year at 31.3%, while Alameda County, Calif., had the lowest rate at 8.1%.
Of the seven states (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina), Mississippi had the highest overall ever-testing rate at 40.2%, and Oklahoma had the lowest at 29.7%. People living in rural areas in those states were less likely to have ever been tested (32.1%) than those living in urban areas (37.2%). The difference between rural and urban areas increased for people at risk for HIV who had been screened in the past year, with 18.4% and 29.0%, respectively, reporting undergoing screening.
“These data provide a baseline from which to measure changes in screening in these jurisdictions and other parts of the United States over time. To achieve national goals and end the HIV epidemic in the United States, innovative and novel screening approaches might be needed to reach segments of the population that have never been tested for HIV,” the investigators concluded.
The investigators reported no conflicts of interest.
SOURCE: Pitasi MA et al. MMWR Morb Mortal Wkly Rep. 2019;68:561-7.
FROM MMWR
FDA approves dupilumab for chronic rhinosinusitis with nasal polyps
The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.
FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.
The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.
“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.
FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.
The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.
“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.
FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.
The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.
“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
