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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.
Clinical trial: Robotic or open radical cystectomy in treating patients with bladder cancer
Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at Clinicaltrials.gov.
Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at Clinicaltrials.gov.
Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at Clinicaltrials.gov.
USPSTF issues draft research plan on opioid use disorder prevention
The U.S. Preventive Services Task Force posted a draft research plan on opioid use disorder prevention for public comment on Dec. 13, according to a USPSTF bulletin.
An estimated 2.1 million persons aged 12 years and older had an opioid use disorder in 2017, and opioids were involved in nearly two-thirds of more than 70,000 fatal drug overdoses, according to the task force. Prevention of unnecessary opioid use, opioid misuse, and opioid use disorder in primary care settings is necessary to effectively respond to the ongoing crisis.
In an extensive literature review, an independent research team will look for evidence on strategies for people not currently receiving opioids that can be implemented on the primary care level. The public is invited to submit comments on the research plan that will help focus and guide the literature review.
The USPSTF also will be updating the current 2008 recommendation statement on screening for illicit drugs and nonmedical prescription drugs in adolescents and young adults, including pregnant and postpartum women.
Comments can be submitted until Jan. 16, 2019, on the USPSTF website.
The U.S. Preventive Services Task Force posted a draft research plan on opioid use disorder prevention for public comment on Dec. 13, according to a USPSTF bulletin.
An estimated 2.1 million persons aged 12 years and older had an opioid use disorder in 2017, and opioids were involved in nearly two-thirds of more than 70,000 fatal drug overdoses, according to the task force. Prevention of unnecessary opioid use, opioid misuse, and opioid use disorder in primary care settings is necessary to effectively respond to the ongoing crisis.
In an extensive literature review, an independent research team will look for evidence on strategies for people not currently receiving opioids that can be implemented on the primary care level. The public is invited to submit comments on the research plan that will help focus and guide the literature review.
The USPSTF also will be updating the current 2008 recommendation statement on screening for illicit drugs and nonmedical prescription drugs in adolescents and young adults, including pregnant and postpartum women.
Comments can be submitted until Jan. 16, 2019, on the USPSTF website.
The U.S. Preventive Services Task Force posted a draft research plan on opioid use disorder prevention for public comment on Dec. 13, according to a USPSTF bulletin.
An estimated 2.1 million persons aged 12 years and older had an opioid use disorder in 2017, and opioids were involved in nearly two-thirds of more than 70,000 fatal drug overdoses, according to the task force. Prevention of unnecessary opioid use, opioid misuse, and opioid use disorder in primary care settings is necessary to effectively respond to the ongoing crisis.
In an extensive literature review, an independent research team will look for evidence on strategies for people not currently receiving opioids that can be implemented on the primary care level. The public is invited to submit comments on the research plan that will help focus and guide the literature review.
The USPSTF also will be updating the current 2008 recommendation statement on screening for illicit drugs and nonmedical prescription drugs in adolescents and young adults, including pregnant and postpartum women.
Comments can be submitted until Jan. 16, 2019, on the USPSTF website.
FDA issues alert over e-liquids with undeclared drugs
The Food and Drug Administration has issued an alert regarding two . E-liquid is the flavored mixture used in electronic cigarettes.
In a laboratory analysis, the FDA found that “E-Cialis HelloCig E-Liquid” contained both sildenafil and tadalafil, and that “E-Rimonabant HelloCig E-Liquid” contained sildenafil. Sildenafil and tadalafil are approved for the treatment of erectile dysfunction. Unapproved usage of these drugs in over-the-counter e-liquids is therefore illegal.
Both sildenafil and tadalafil can interact with nitrates found in some prescription drugs and can cause a dangerous lowering of blood pressure. Conditions commonly treated with nitrates include diabetes, high blood pressure, high cholesterol, or heart disease.
“FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation. Therefore, FDA urges consumers to stop using these products and to contact their health care professional with any concerns associated with their use,” the FDA said in the press release.
Find the full press release on the FDA website.
The Food and Drug Administration has issued an alert regarding two . E-liquid is the flavored mixture used in electronic cigarettes.
In a laboratory analysis, the FDA found that “E-Cialis HelloCig E-Liquid” contained both sildenafil and tadalafil, and that “E-Rimonabant HelloCig E-Liquid” contained sildenafil. Sildenafil and tadalafil are approved for the treatment of erectile dysfunction. Unapproved usage of these drugs in over-the-counter e-liquids is therefore illegal.
Both sildenafil and tadalafil can interact with nitrates found in some prescription drugs and can cause a dangerous lowering of blood pressure. Conditions commonly treated with nitrates include diabetes, high blood pressure, high cholesterol, or heart disease.
“FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation. Therefore, FDA urges consumers to stop using these products and to contact their health care professional with any concerns associated with their use,” the FDA said in the press release.
Find the full press release on the FDA website.
The Food and Drug Administration has issued an alert regarding two . E-liquid is the flavored mixture used in electronic cigarettes.
In a laboratory analysis, the FDA found that “E-Cialis HelloCig E-Liquid” contained both sildenafil and tadalafil, and that “E-Rimonabant HelloCig E-Liquid” contained sildenafil. Sildenafil and tadalafil are approved for the treatment of erectile dysfunction. Unapproved usage of these drugs in over-the-counter e-liquids is therefore illegal.
Both sildenafil and tadalafil can interact with nitrates found in some prescription drugs and can cause a dangerous lowering of blood pressure. Conditions commonly treated with nitrates include diabetes, high blood pressure, high cholesterol, or heart disease.
“FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation. Therefore, FDA urges consumers to stop using these products and to contact their health care professional with any concerns associated with their use,” the FDA said in the press release.
Find the full press release on the FDA website.
Wasp-stung lung bugs, fat clay, Botoxed Vulcans, and ‘GOT’ mortality risk
The wonderful world of wasps
Never thought you’d be thankful for wasps, did you? Neither did we. Using mice as test subjects, scientists at MIT found that a tiny peptide in the venom was able to completely eliminate Pseudomonas aeruginosa, which causes respiratory infections and is often resistant to antibiotics. Now if you’re sick, all you have to do is go outside and get stung by a bunch of wasps!
Wait, no, that’s not right. The researchers at MIT engineered a molecule that can be used to create an antibiotic that’s safe for humans. While most insect venom is chock full of compounds that are toxic to humans, the scientists were able to transform their tiny peptide into a bacteria-defeating machine. This is a big victory in the war against antibiotic-resistant bacteria. Go, wasps!
Live long and Botox
Talk about highly illogical! Botox patients sometimes return for follow-up visits with dermatologist Kelly Stankiewicz, MD, and haven’t noticed they’ve “Spocked,” even though it may be obvious to just about everyone else.
But other Botox patients are most certainly aware that their eyebrows have arched up on the right and left sides – just like those of a certain Vulcan character on “Star Trek.” And they want to be beamed out of that uncomfortable situation pronto.
Dr. Stankiewicz, who works in Park City, Utah, explained the “Spocking” phenomenon in a presentation about facial treatments at the recent Las Vegas Dermatology Symposium. Spocking can occur in patents who get Botox treatment to eliminate the “11 line” – two vertical wrinkles – between the eyebrows, Dr. Stankiewicz said. It occurs “when the middle of the forehead doesn’t move but the outside does,” she said, causing an unsightly outwardly arched eyebrow look.
The solution to Spocking is easy, she said: “Put a tiny bit of Botox in the forehead muscle right where the eyebrow is peaking the most.”
Leonard Nimoy, the original Mr. Spock, is not available for comment, given that he died in 2015. But Dr. Stankiewicz does have a perspective on Mr. Spock’s trademark look: “It’s like the people who drew his brow knew that Botox was on the horizon.”
Add the dirt, lose the fat
Lots of things are supposed to be stronger than dirt, but it looks like obesity might not be one of them. Investigators who were trying to improve drug delivery using a type of clay – spray-dried smectite clay particles, to be exact – discovered that it has “a unique ability to ‘soak up’ fat droplets in the gut,” according to a statement from the University of South Australia, Adelaide.
“Not only were the clay materials trapping the fats within their particle structure, but they were also preventing them from being absorbed by the body, ensuring that fat simply passed through the digestive system,” researcher Tahnee J. Dening said.
In the study, the smectite outperformed the weight-loss drug orlistat in rats fed a high-fat diet for 2 weeks (Pharm Res. 2019;36:21 doi: 10.1007/s11095-018-2552-9). Even better, smectite is already widely used in foods and nutraceuticals and is considered to be safe. Even even better, smectite is a really fun word to say. And with the prevalence of obesity such as it is, we’re sure that physicians will prescribe smectite just so they can say “smectite” to their patients. Smectite.
When you play the game of thrones …
… You conduct an evidence-based analysis of mortality across the Seven Kingdoms. In celebration of the approaching final season, two researchers published a study of mortality and survival in HBO’s “Game of Thrones” series. They examined data on sociodemographic factors and circumstances of death to identify predictors of mortality.
After looking at 330 characters from the show (186 who suffered death), the authors determined that being male, lowborn, and loyal had the highest correlation with mortality. Poor men who never switched their allegiance from one side to the other had the lowest chance of survival. In addition, the probability of dying in the first hour after appearing on screen was 14%. Not a good statistic if you’re trying to become famous in Westeros. And a mortality risk rivaling even that of Mr. Spock’s red-shirted shipmates down in engineering.
Nurse, sand wedge, STAT!
There really is no sport like golf. The wide green spaces, the fresh air, the thrill of launching a 300-yard drive down the fairway, the fun of double-bogeying the last three holes to shoot yet another 93; golf is a noble pursuit, indeed. And a sport everyone knows doctors love. Right?
In research published in the Christmas edition of the BMJ, a group of doctors from Massachusetts sought to find out just how accurate the stereotype was. Their answer? Doctors really do enjoy teeing it up.
Well, male doctors.
Well, old male doctors.
Using a database of about a million physicians, the researchers found that 5.5% of male physicians and 1.3% of female physicians – or 4.1% overall – maintained an official United States Golf Association handicap. Male physicians aged 61-70 years were most likely to play, and female physicians aged 31-35 years were least likely.
However, while golf is certainly a common pastime among doctors, they aren’t exactly very good at it, as the average doctor is actually slightly worse than the average nondoctor. Surgeons presented a notable exception, possessing significantly lower handicaps than their colleagues while, perhaps not coincidentally, also playing more often. We’re sure there’s a joke about overpaid surgeons in narrow specialties having too much time on their hands, and we’ll get right back to you with it after our 12 o’clock tee time.
The wonderful world of wasps
Never thought you’d be thankful for wasps, did you? Neither did we. Using mice as test subjects, scientists at MIT found that a tiny peptide in the venom was able to completely eliminate Pseudomonas aeruginosa, which causes respiratory infections and is often resistant to antibiotics. Now if you’re sick, all you have to do is go outside and get stung by a bunch of wasps!
Wait, no, that’s not right. The researchers at MIT engineered a molecule that can be used to create an antibiotic that’s safe for humans. While most insect venom is chock full of compounds that are toxic to humans, the scientists were able to transform their tiny peptide into a bacteria-defeating machine. This is a big victory in the war against antibiotic-resistant bacteria. Go, wasps!
Live long and Botox
Talk about highly illogical! Botox patients sometimes return for follow-up visits with dermatologist Kelly Stankiewicz, MD, and haven’t noticed they’ve “Spocked,” even though it may be obvious to just about everyone else.
But other Botox patients are most certainly aware that their eyebrows have arched up on the right and left sides – just like those of a certain Vulcan character on “Star Trek.” And they want to be beamed out of that uncomfortable situation pronto.
Dr. Stankiewicz, who works in Park City, Utah, explained the “Spocking” phenomenon in a presentation about facial treatments at the recent Las Vegas Dermatology Symposium. Spocking can occur in patents who get Botox treatment to eliminate the “11 line” – two vertical wrinkles – between the eyebrows, Dr. Stankiewicz said. It occurs “when the middle of the forehead doesn’t move but the outside does,” she said, causing an unsightly outwardly arched eyebrow look.
The solution to Spocking is easy, she said: “Put a tiny bit of Botox in the forehead muscle right where the eyebrow is peaking the most.”
Leonard Nimoy, the original Mr. Spock, is not available for comment, given that he died in 2015. But Dr. Stankiewicz does have a perspective on Mr. Spock’s trademark look: “It’s like the people who drew his brow knew that Botox was on the horizon.”
Add the dirt, lose the fat
Lots of things are supposed to be stronger than dirt, but it looks like obesity might not be one of them. Investigators who were trying to improve drug delivery using a type of clay – spray-dried smectite clay particles, to be exact – discovered that it has “a unique ability to ‘soak up’ fat droplets in the gut,” according to a statement from the University of South Australia, Adelaide.
“Not only were the clay materials trapping the fats within their particle structure, but they were also preventing them from being absorbed by the body, ensuring that fat simply passed through the digestive system,” researcher Tahnee J. Dening said.
In the study, the smectite outperformed the weight-loss drug orlistat in rats fed a high-fat diet for 2 weeks (Pharm Res. 2019;36:21 doi: 10.1007/s11095-018-2552-9). Even better, smectite is already widely used in foods and nutraceuticals and is considered to be safe. Even even better, smectite is a really fun word to say. And with the prevalence of obesity such as it is, we’re sure that physicians will prescribe smectite just so they can say “smectite” to their patients. Smectite.
When you play the game of thrones …
… You conduct an evidence-based analysis of mortality across the Seven Kingdoms. In celebration of the approaching final season, two researchers published a study of mortality and survival in HBO’s “Game of Thrones” series. They examined data on sociodemographic factors and circumstances of death to identify predictors of mortality.
After looking at 330 characters from the show (186 who suffered death), the authors determined that being male, lowborn, and loyal had the highest correlation with mortality. Poor men who never switched their allegiance from one side to the other had the lowest chance of survival. In addition, the probability of dying in the first hour after appearing on screen was 14%. Not a good statistic if you’re trying to become famous in Westeros. And a mortality risk rivaling even that of Mr. Spock’s red-shirted shipmates down in engineering.
Nurse, sand wedge, STAT!
There really is no sport like golf. The wide green spaces, the fresh air, the thrill of launching a 300-yard drive down the fairway, the fun of double-bogeying the last three holes to shoot yet another 93; golf is a noble pursuit, indeed. And a sport everyone knows doctors love. Right?
In research published in the Christmas edition of the BMJ, a group of doctors from Massachusetts sought to find out just how accurate the stereotype was. Their answer? Doctors really do enjoy teeing it up.
Well, male doctors.
Well, old male doctors.
Using a database of about a million physicians, the researchers found that 5.5% of male physicians and 1.3% of female physicians – or 4.1% overall – maintained an official United States Golf Association handicap. Male physicians aged 61-70 years were most likely to play, and female physicians aged 31-35 years were least likely.
However, while golf is certainly a common pastime among doctors, they aren’t exactly very good at it, as the average doctor is actually slightly worse than the average nondoctor. Surgeons presented a notable exception, possessing significantly lower handicaps than their colleagues while, perhaps not coincidentally, also playing more often. We’re sure there’s a joke about overpaid surgeons in narrow specialties having too much time on their hands, and we’ll get right back to you with it after our 12 o’clock tee time.
The wonderful world of wasps
Never thought you’d be thankful for wasps, did you? Neither did we. Using mice as test subjects, scientists at MIT found that a tiny peptide in the venom was able to completely eliminate Pseudomonas aeruginosa, which causes respiratory infections and is often resistant to antibiotics. Now if you’re sick, all you have to do is go outside and get stung by a bunch of wasps!
Wait, no, that’s not right. The researchers at MIT engineered a molecule that can be used to create an antibiotic that’s safe for humans. While most insect venom is chock full of compounds that are toxic to humans, the scientists were able to transform their tiny peptide into a bacteria-defeating machine. This is a big victory in the war against antibiotic-resistant bacteria. Go, wasps!
Live long and Botox
Talk about highly illogical! Botox patients sometimes return for follow-up visits with dermatologist Kelly Stankiewicz, MD, and haven’t noticed they’ve “Spocked,” even though it may be obvious to just about everyone else.
But other Botox patients are most certainly aware that their eyebrows have arched up on the right and left sides – just like those of a certain Vulcan character on “Star Trek.” And they want to be beamed out of that uncomfortable situation pronto.
Dr. Stankiewicz, who works in Park City, Utah, explained the “Spocking” phenomenon in a presentation about facial treatments at the recent Las Vegas Dermatology Symposium. Spocking can occur in patents who get Botox treatment to eliminate the “11 line” – two vertical wrinkles – between the eyebrows, Dr. Stankiewicz said. It occurs “when the middle of the forehead doesn’t move but the outside does,” she said, causing an unsightly outwardly arched eyebrow look.
The solution to Spocking is easy, she said: “Put a tiny bit of Botox in the forehead muscle right where the eyebrow is peaking the most.”
Leonard Nimoy, the original Mr. Spock, is not available for comment, given that he died in 2015. But Dr. Stankiewicz does have a perspective on Mr. Spock’s trademark look: “It’s like the people who drew his brow knew that Botox was on the horizon.”
Add the dirt, lose the fat
Lots of things are supposed to be stronger than dirt, but it looks like obesity might not be one of them. Investigators who were trying to improve drug delivery using a type of clay – spray-dried smectite clay particles, to be exact – discovered that it has “a unique ability to ‘soak up’ fat droplets in the gut,” according to a statement from the University of South Australia, Adelaide.
“Not only were the clay materials trapping the fats within their particle structure, but they were also preventing them from being absorbed by the body, ensuring that fat simply passed through the digestive system,” researcher Tahnee J. Dening said.
In the study, the smectite outperformed the weight-loss drug orlistat in rats fed a high-fat diet for 2 weeks (Pharm Res. 2019;36:21 doi: 10.1007/s11095-018-2552-9). Even better, smectite is already widely used in foods and nutraceuticals and is considered to be safe. Even even better, smectite is a really fun word to say. And with the prevalence of obesity such as it is, we’re sure that physicians will prescribe smectite just so they can say “smectite” to their patients. Smectite.
When you play the game of thrones …
… You conduct an evidence-based analysis of mortality across the Seven Kingdoms. In celebration of the approaching final season, two researchers published a study of mortality and survival in HBO’s “Game of Thrones” series. They examined data on sociodemographic factors and circumstances of death to identify predictors of mortality.
After looking at 330 characters from the show (186 who suffered death), the authors determined that being male, lowborn, and loyal had the highest correlation with mortality. Poor men who never switched their allegiance from one side to the other had the lowest chance of survival. In addition, the probability of dying in the first hour after appearing on screen was 14%. Not a good statistic if you’re trying to become famous in Westeros. And a mortality risk rivaling even that of Mr. Spock’s red-shirted shipmates down in engineering.
Nurse, sand wedge, STAT!
There really is no sport like golf. The wide green spaces, the fresh air, the thrill of launching a 300-yard drive down the fairway, the fun of double-bogeying the last three holes to shoot yet another 93; golf is a noble pursuit, indeed. And a sport everyone knows doctors love. Right?
In research published in the Christmas edition of the BMJ, a group of doctors from Massachusetts sought to find out just how accurate the stereotype was. Their answer? Doctors really do enjoy teeing it up.
Well, male doctors.
Well, old male doctors.
Using a database of about a million physicians, the researchers found that 5.5% of male physicians and 1.3% of female physicians – or 4.1% overall – maintained an official United States Golf Association handicap. Male physicians aged 61-70 years were most likely to play, and female physicians aged 31-35 years were least likely.
However, while golf is certainly a common pastime among doctors, they aren’t exactly very good at it, as the average doctor is actually slightly worse than the average nondoctor. Surgeons presented a notable exception, possessing significantly lower handicaps than their colleagues while, perhaps not coincidentally, also playing more often. We’re sure there’s a joke about overpaid surgeons in narrow specialties having too much time on their hands, and we’ll get right back to you with it after our 12 o’clock tee time.
ICYMI: Durvalumab boosts overall survival in stage III NSCLC
Patients with unresectable stage III non–small cell lung cancer who received durvalumab had their overall and progression-free survival boosted by about 12 months, compared with patients who received a placebo, according to results of the multicenter, randomized, double-blind, placebo-controlled, phase 3 PACIFIC trial published in the New England Journal of Medicine (2018 Sep 25. doi: 10.1056/NEJMoa1809697).
We covered this story at the World Conference on Lung Cancer before it was published in the journal. Find our coverage at the link below.
Patients with unresectable stage III non–small cell lung cancer who received durvalumab had their overall and progression-free survival boosted by about 12 months, compared with patients who received a placebo, according to results of the multicenter, randomized, double-blind, placebo-controlled, phase 3 PACIFIC trial published in the New England Journal of Medicine (2018 Sep 25. doi: 10.1056/NEJMoa1809697).
We covered this story at the World Conference on Lung Cancer before it was published in the journal. Find our coverage at the link below.
Patients with unresectable stage III non–small cell lung cancer who received durvalumab had their overall and progression-free survival boosted by about 12 months, compared with patients who received a placebo, according to results of the multicenter, randomized, double-blind, placebo-controlled, phase 3 PACIFIC trial published in the New England Journal of Medicine (2018 Sep 25. doi: 10.1056/NEJMoa1809697).
We covered this story at the World Conference on Lung Cancer before it was published in the journal. Find our coverage at the link below.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Clinical trial: Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery
The trial will assess the incidence of postoperative pulmonary complications in patients who receive mechanical ventilation while under general anesthesia during robotic surgery to characterize current ventilation practices and evaluate any association between ventilator parameters and postoperative pulmonary complications.
Patients will be included if they are at least 18 years old and had their robotic surgical procedure done under general anesthesia. Exclusion criteria include being pregnant during surgery and having their procedure done outside an operating room.
The primary outcome measure is incidence of postoperative pulmonary complications within 5 days of the procedure or hospital discharge. Secondary outcomes include intraoperative mechanical ventilation practice, mechanical ventilation practice, and postoperative pulmonary complications within 5 days of the procedure or hospital discharge, intraoperative surgical positioning and ventilation, preoperative risk for postoperative pulmonary complications, and intraoperative mechanical ventilation practice and complications.
The estimated primary completion date is March 1, 2019, and the estimated study completion date is May 1, 2019. About 500 patients are estimated to be enrolled.
Find more information on the study at Clinicaltrials.gov.
The trial will assess the incidence of postoperative pulmonary complications in patients who receive mechanical ventilation while under general anesthesia during robotic surgery to characterize current ventilation practices and evaluate any association between ventilator parameters and postoperative pulmonary complications.
Patients will be included if they are at least 18 years old and had their robotic surgical procedure done under general anesthesia. Exclusion criteria include being pregnant during surgery and having their procedure done outside an operating room.
The primary outcome measure is incidence of postoperative pulmonary complications within 5 days of the procedure or hospital discharge. Secondary outcomes include intraoperative mechanical ventilation practice, mechanical ventilation practice, and postoperative pulmonary complications within 5 days of the procedure or hospital discharge, intraoperative surgical positioning and ventilation, preoperative risk for postoperative pulmonary complications, and intraoperative mechanical ventilation practice and complications.
The estimated primary completion date is March 1, 2019, and the estimated study completion date is May 1, 2019. About 500 patients are estimated to be enrolled.
Find more information on the study at Clinicaltrials.gov.
The trial will assess the incidence of postoperative pulmonary complications in patients who receive mechanical ventilation while under general anesthesia during robotic surgery to characterize current ventilation practices and evaluate any association between ventilator parameters and postoperative pulmonary complications.
Patients will be included if they are at least 18 years old and had their robotic surgical procedure done under general anesthesia. Exclusion criteria include being pregnant during surgery and having their procedure done outside an operating room.
The primary outcome measure is incidence of postoperative pulmonary complications within 5 days of the procedure or hospital discharge. Secondary outcomes include intraoperative mechanical ventilation practice, mechanical ventilation practice, and postoperative pulmonary complications within 5 days of the procedure or hospital discharge, intraoperative surgical positioning and ventilation, preoperative risk for postoperative pulmonary complications, and intraoperative mechanical ventilation practice and complications.
The estimated primary completion date is March 1, 2019, and the estimated study completion date is May 1, 2019. About 500 patients are estimated to be enrolled.
Find more information on the study at Clinicaltrials.gov.
Clinical trial: Treating Sleep Apnea in Female Veterans
The Treating Sleep Apnea in Women Veterans study is an interventional, randomized, controlled trial for woman veterans recently diagnosed with sleep apnea and prescribed positive airway pressure (PAP) treatment with at least one risk factor for sleep-disordered breathing (SDB).
The trial will compare the efficacy of two different programs combining patient education with behavioral techniques to improve adherence to PAP therapy in women veterans. The recommended first-line treatment for SDB is PAP therapy, but women have been shown to have lower adherence to men, especially in woman veterans, who experience significant sleep disturbance and other consequences of sleep disorders. No study has tested possible interventions to increase PAP adherence in this population.
Among inclusion criteria are being a woman veteran aged at least 18 years, having received care from a Veterans Affairs facility, and having been diagnosed with sleep apnea with an apnea-hypopnea index of 5 or greater. Patients will be excluded if they are currently using a sleep apnea treatment, are pregnant, are an active substance user or started recovery in the past 90 days, are too ill to participate, do not have transportation, cannot self-consent, have unstable housing, have another sleep disorder that accounts for sleep disturbance, or have no sleep complaints or symptoms.
The primary outcome measures are PAP adherence 3 months post PAP initiation and sleep quality by patient-reported sleep questionnaire 3 months after randomizations. In addition, remote PAP usage data will be collected for 12 months post PAP initiation.
The estimated primary completion date is Dec. 21, 2021, and the estimated study completion date is Jan. 31, 2022. About 300 patients are estimated to be recruited.
Find more information on the study page at Clinicaltrials.gov.
The Treating Sleep Apnea in Women Veterans study is an interventional, randomized, controlled trial for woman veterans recently diagnosed with sleep apnea and prescribed positive airway pressure (PAP) treatment with at least one risk factor for sleep-disordered breathing (SDB).
The trial will compare the efficacy of two different programs combining patient education with behavioral techniques to improve adherence to PAP therapy in women veterans. The recommended first-line treatment for SDB is PAP therapy, but women have been shown to have lower adherence to men, especially in woman veterans, who experience significant sleep disturbance and other consequences of sleep disorders. No study has tested possible interventions to increase PAP adherence in this population.
Among inclusion criteria are being a woman veteran aged at least 18 years, having received care from a Veterans Affairs facility, and having been diagnosed with sleep apnea with an apnea-hypopnea index of 5 or greater. Patients will be excluded if they are currently using a sleep apnea treatment, are pregnant, are an active substance user or started recovery in the past 90 days, are too ill to participate, do not have transportation, cannot self-consent, have unstable housing, have another sleep disorder that accounts for sleep disturbance, or have no sleep complaints or symptoms.
The primary outcome measures are PAP adherence 3 months post PAP initiation and sleep quality by patient-reported sleep questionnaire 3 months after randomizations. In addition, remote PAP usage data will be collected for 12 months post PAP initiation.
The estimated primary completion date is Dec. 21, 2021, and the estimated study completion date is Jan. 31, 2022. About 300 patients are estimated to be recruited.
Find more information on the study page at Clinicaltrials.gov.
The Treating Sleep Apnea in Women Veterans study is an interventional, randomized, controlled trial for woman veterans recently diagnosed with sleep apnea and prescribed positive airway pressure (PAP) treatment with at least one risk factor for sleep-disordered breathing (SDB).
The trial will compare the efficacy of two different programs combining patient education with behavioral techniques to improve adherence to PAP therapy in women veterans. The recommended first-line treatment for SDB is PAP therapy, but women have been shown to have lower adherence to men, especially in woman veterans, who experience significant sleep disturbance and other consequences of sleep disorders. No study has tested possible interventions to increase PAP adherence in this population.
Among inclusion criteria are being a woman veteran aged at least 18 years, having received care from a Veterans Affairs facility, and having been diagnosed with sleep apnea with an apnea-hypopnea index of 5 or greater. Patients will be excluded if they are currently using a sleep apnea treatment, are pregnant, are an active substance user or started recovery in the past 90 days, are too ill to participate, do not have transportation, cannot self-consent, have unstable housing, have another sleep disorder that accounts for sleep disturbance, or have no sleep complaints or symptoms.
The primary outcome measures are PAP adherence 3 months post PAP initiation and sleep quality by patient-reported sleep questionnaire 3 months after randomizations. In addition, remote PAP usage data will be collected for 12 months post PAP initiation.
The estimated primary completion date is Dec. 21, 2021, and the estimated study completion date is Jan. 31, 2022. About 300 patients are estimated to be recruited.
Find more information on the study page at Clinicaltrials.gov.
Clinical trial: Magnetic Resonance Imaging in Obstructive Sleep Apnea
The Magnetic Resonance Imaging in Obstructive Sleep Apnea trial is an observational cohort study recruiting adults with obstructive sleep apnea undergoing surgery.
The trial will compare drug-induced sleep endoscopy and upper airway MRI in order to determine which is the better predictor of success in patients who cannot tolerate nonsurgical solutions. Upper airway MRI is a more complete evaluation during wakefulness and is cheaper than drug-induced sleep endoscopy, but no studies have thus far utilized MRI as a surgical evaluation tool.
Patients will be included if they are at least 21 years old, have moderate to severe obstructive sleep apnea, and have a body mass index less than 40 kg/m2. Exclusion criteria include prior surgery for obstructive sleep apnea; known neurologic, cardiac, pulmonary, renal, or hepatic disorders; psychiatric problems except for treated depression or mild anxiety; a coexisting sleep disorder; or another contraindication to drug-induced sleep endoscopy or MRI, such as propofol allergy.
The primary outcome measure is surgical results after 6 months, which will be measured using sleep studies. Secondary outcomes include sleep-related quality of life after 6 months and daytime sleepiness after 6 months.
The estimated primary completion date is June 2020, and the estimated study completion date is July 2020. About 40 patients are expected to be recruited.
Find more information on the study page at Clinicaltrials.gov.
The Magnetic Resonance Imaging in Obstructive Sleep Apnea trial is an observational cohort study recruiting adults with obstructive sleep apnea undergoing surgery.
The trial will compare drug-induced sleep endoscopy and upper airway MRI in order to determine which is the better predictor of success in patients who cannot tolerate nonsurgical solutions. Upper airway MRI is a more complete evaluation during wakefulness and is cheaper than drug-induced sleep endoscopy, but no studies have thus far utilized MRI as a surgical evaluation tool.
Patients will be included if they are at least 21 years old, have moderate to severe obstructive sleep apnea, and have a body mass index less than 40 kg/m2. Exclusion criteria include prior surgery for obstructive sleep apnea; known neurologic, cardiac, pulmonary, renal, or hepatic disorders; psychiatric problems except for treated depression or mild anxiety; a coexisting sleep disorder; or another contraindication to drug-induced sleep endoscopy or MRI, such as propofol allergy.
The primary outcome measure is surgical results after 6 months, which will be measured using sleep studies. Secondary outcomes include sleep-related quality of life after 6 months and daytime sleepiness after 6 months.
The estimated primary completion date is June 2020, and the estimated study completion date is July 2020. About 40 patients are expected to be recruited.
Find more information on the study page at Clinicaltrials.gov.
The Magnetic Resonance Imaging in Obstructive Sleep Apnea trial is an observational cohort study recruiting adults with obstructive sleep apnea undergoing surgery.
The trial will compare drug-induced sleep endoscopy and upper airway MRI in order to determine which is the better predictor of success in patients who cannot tolerate nonsurgical solutions. Upper airway MRI is a more complete evaluation during wakefulness and is cheaper than drug-induced sleep endoscopy, but no studies have thus far utilized MRI as a surgical evaluation tool.
Patients will be included if they are at least 21 years old, have moderate to severe obstructive sleep apnea, and have a body mass index less than 40 kg/m2. Exclusion criteria include prior surgery for obstructive sleep apnea; known neurologic, cardiac, pulmonary, renal, or hepatic disorders; psychiatric problems except for treated depression or mild anxiety; a coexisting sleep disorder; or another contraindication to drug-induced sleep endoscopy or MRI, such as propofol allergy.
The primary outcome measure is surgical results after 6 months, which will be measured using sleep studies. Secondary outcomes include sleep-related quality of life after 6 months and daytime sleepiness after 6 months.
The estimated primary completion date is June 2020, and the estimated study completion date is July 2020. About 40 patients are expected to be recruited.
Find more information on the study page at Clinicaltrials.gov.
Legos for lunch, saliva-sterilized pacifiers, and a healthy personality
Legos for lunch
As any parent, teacher, or teenage babysitter knows, children try to eat everything. Six intrepid researchers from Australia and the United Kingdom decided to put their lives – or, at least, their intestines – on the line by swallowing Lego pieces to determine “typical transit times” for the commonly ingested toy. The things people do in the name of science.
The study participants first measured their bowel habits by the Stool Hardness and Transit (SHAT) score, and then measured the Found and Retrieved Time (FART) score once the Lego was ... expelled. The researchers found that the average FART score was 1.71 days.
At this point, all involved stopped to have a hearty laugh and a round of high-fives. Parents can rest assured that their little progeny who swallow Legos are safe. Everything is awesome.
Don’t wash that pacifier!
If you want to clean your child’s pacifier, you should consider passing on the sink and pop it into your own mouth instead. That’s the story from research presented at the annual scientific meeting of the American College of Allergy, Asthma, and Immunology.
In a survey of 128 mothers over an 18-month period, 41% of those whose child was currently using a pacifier reported cleaning by sterilization, and 72% reported hand washing their child’s pacifier. (We will henceforth refer to these mothers as “normal people.”) Just over 10% of mothers reported cleaning through parental pacifier sucking.
Before you cringe too much, the children of these mothers had significantly lower IgE levels than the children of normal people, indicating they were at a lower risk of developing allergies or asthma.
The study authors hypothesized that exposure to adult saliva may transfer healthy microorganisms to their children, and they advocated for further study into the subject. We suggest getting the pediatricians from the Lego study involved – they’ll eat anything for science.
One camel latte, please
An unlikely partnership between a Saudi entrepreneur and Amish farmers might lead to a brand-new dairy market in the United States. Walid Abdul-Wahub is on a mission to put camel milk on the shelves of every grocery store in America.
Middle Eastern residents have been drinking camel milk for centuries, so it’s only a matter of time until some hipster coffee shop co-opts it and starts selling camel milk lattes for $9. On the plus side, camel milk has a different protein than cow milk, making it more similar to human milk than bovine milk. This could be a godsend for people with milk allergies and need alternatives to that god-awful almond milk. One camel milkshake, coming right up.
How healthy is your personality?
It’s a question bipedal hominins have pondered since our days scrounging for snacks in the Olduvai Gorge: Is my personality why no one wants to hunt and gather with me?
Homo sapiens researchers from the University of California, Davis, and elsewhere believe they have the answer. In fact, it is your personality that leaves you scavenging for baobab alone.
What’s a healthy personality? The Scientia sapiens split personality into five factors: agreeableness, conscientiousness, extroversion, neuroticism, and openness to experience. They then surveyed scientists and college students to construct the consensus Dream Date – er, healthy personality: low levels of neuroticism, sprinkled with lots of agreeable straightforwardness, openness to feelings, positive emotions, and warmth. It wouldn’t hurt to ease up on the Old Spice, either.
The taste of deprivation
At one time or another, you’ve probably seen someone who was pretty much physically attached to his or her phone and wondered about the owner’s personal priorities and where the phone fit into them.
Wonder no more.
In a study conducted at the University at Buffalo (N.Y.), 76 students were deprived of food for 3 hours and their smartphones for 2 hours, and then given a computer task that would earn them a serving of their favorite snack or use of their phone. To make things more interesting, the amount of work needed to earn food or phone time increased as the subjects completed their tasks.
“We knew that students would be motivated to gain access to their phones, but we were surprised that, despite modest food deprivation, smartphone reinforcement far exceeded food reinforcement,” lead investigator Sara O’Donnell said in a written statement.
Recruiting subjects for the next step in this line of research – choosing between phones and breathing – could get a little tricky. But we have to admire the creative solution that got one participant disqualified from the current study: He tried to eat his phone.
Legos for lunch
As any parent, teacher, or teenage babysitter knows, children try to eat everything. Six intrepid researchers from Australia and the United Kingdom decided to put their lives – or, at least, their intestines – on the line by swallowing Lego pieces to determine “typical transit times” for the commonly ingested toy. The things people do in the name of science.
The study participants first measured their bowel habits by the Stool Hardness and Transit (SHAT) score, and then measured the Found and Retrieved Time (FART) score once the Lego was ... expelled. The researchers found that the average FART score was 1.71 days.
At this point, all involved stopped to have a hearty laugh and a round of high-fives. Parents can rest assured that their little progeny who swallow Legos are safe. Everything is awesome.
Don’t wash that pacifier!
If you want to clean your child’s pacifier, you should consider passing on the sink and pop it into your own mouth instead. That’s the story from research presented at the annual scientific meeting of the American College of Allergy, Asthma, and Immunology.
In a survey of 128 mothers over an 18-month period, 41% of those whose child was currently using a pacifier reported cleaning by sterilization, and 72% reported hand washing their child’s pacifier. (We will henceforth refer to these mothers as “normal people.”) Just over 10% of mothers reported cleaning through parental pacifier sucking.
Before you cringe too much, the children of these mothers had significantly lower IgE levels than the children of normal people, indicating they were at a lower risk of developing allergies or asthma.
The study authors hypothesized that exposure to adult saliva may transfer healthy microorganisms to their children, and they advocated for further study into the subject. We suggest getting the pediatricians from the Lego study involved – they’ll eat anything for science.
One camel latte, please
An unlikely partnership between a Saudi entrepreneur and Amish farmers might lead to a brand-new dairy market in the United States. Walid Abdul-Wahub is on a mission to put camel milk on the shelves of every grocery store in America.
Middle Eastern residents have been drinking camel milk for centuries, so it’s only a matter of time until some hipster coffee shop co-opts it and starts selling camel milk lattes for $9. On the plus side, camel milk has a different protein than cow milk, making it more similar to human milk than bovine milk. This could be a godsend for people with milk allergies and need alternatives to that god-awful almond milk. One camel milkshake, coming right up.
How healthy is your personality?
It’s a question bipedal hominins have pondered since our days scrounging for snacks in the Olduvai Gorge: Is my personality why no one wants to hunt and gather with me?
Homo sapiens researchers from the University of California, Davis, and elsewhere believe they have the answer. In fact, it is your personality that leaves you scavenging for baobab alone.
What’s a healthy personality? The Scientia sapiens split personality into five factors: agreeableness, conscientiousness, extroversion, neuroticism, and openness to experience. They then surveyed scientists and college students to construct the consensus Dream Date – er, healthy personality: low levels of neuroticism, sprinkled with lots of agreeable straightforwardness, openness to feelings, positive emotions, and warmth. It wouldn’t hurt to ease up on the Old Spice, either.
The taste of deprivation
At one time or another, you’ve probably seen someone who was pretty much physically attached to his or her phone and wondered about the owner’s personal priorities and where the phone fit into them.
Wonder no more.
In a study conducted at the University at Buffalo (N.Y.), 76 students were deprived of food for 3 hours and their smartphones for 2 hours, and then given a computer task that would earn them a serving of their favorite snack or use of their phone. To make things more interesting, the amount of work needed to earn food or phone time increased as the subjects completed their tasks.
“We knew that students would be motivated to gain access to their phones, but we were surprised that, despite modest food deprivation, smartphone reinforcement far exceeded food reinforcement,” lead investigator Sara O’Donnell said in a written statement.
Recruiting subjects for the next step in this line of research – choosing between phones and breathing – could get a little tricky. But we have to admire the creative solution that got one participant disqualified from the current study: He tried to eat his phone.
Legos for lunch
As any parent, teacher, or teenage babysitter knows, children try to eat everything. Six intrepid researchers from Australia and the United Kingdom decided to put their lives – or, at least, their intestines – on the line by swallowing Lego pieces to determine “typical transit times” for the commonly ingested toy. The things people do in the name of science.
The study participants first measured their bowel habits by the Stool Hardness and Transit (SHAT) score, and then measured the Found and Retrieved Time (FART) score once the Lego was ... expelled. The researchers found that the average FART score was 1.71 days.
At this point, all involved stopped to have a hearty laugh and a round of high-fives. Parents can rest assured that their little progeny who swallow Legos are safe. Everything is awesome.
Don’t wash that pacifier!
If you want to clean your child’s pacifier, you should consider passing on the sink and pop it into your own mouth instead. That’s the story from research presented at the annual scientific meeting of the American College of Allergy, Asthma, and Immunology.
In a survey of 128 mothers over an 18-month period, 41% of those whose child was currently using a pacifier reported cleaning by sterilization, and 72% reported hand washing their child’s pacifier. (We will henceforth refer to these mothers as “normal people.”) Just over 10% of mothers reported cleaning through parental pacifier sucking.
Before you cringe too much, the children of these mothers had significantly lower IgE levels than the children of normal people, indicating they were at a lower risk of developing allergies or asthma.
The study authors hypothesized that exposure to adult saliva may transfer healthy microorganisms to their children, and they advocated for further study into the subject. We suggest getting the pediatricians from the Lego study involved – they’ll eat anything for science.
One camel latte, please
An unlikely partnership between a Saudi entrepreneur and Amish farmers might lead to a brand-new dairy market in the United States. Walid Abdul-Wahub is on a mission to put camel milk on the shelves of every grocery store in America.
Middle Eastern residents have been drinking camel milk for centuries, so it’s only a matter of time until some hipster coffee shop co-opts it and starts selling camel milk lattes for $9. On the plus side, camel milk has a different protein than cow milk, making it more similar to human milk than bovine milk. This could be a godsend for people with milk allergies and need alternatives to that god-awful almond milk. One camel milkshake, coming right up.
How healthy is your personality?
It’s a question bipedal hominins have pondered since our days scrounging for snacks in the Olduvai Gorge: Is my personality why no one wants to hunt and gather with me?
Homo sapiens researchers from the University of California, Davis, and elsewhere believe they have the answer. In fact, it is your personality that leaves you scavenging for baobab alone.
What’s a healthy personality? The Scientia sapiens split personality into five factors: agreeableness, conscientiousness, extroversion, neuroticism, and openness to experience. They then surveyed scientists and college students to construct the consensus Dream Date – er, healthy personality: low levels of neuroticism, sprinkled with lots of agreeable straightforwardness, openness to feelings, positive emotions, and warmth. It wouldn’t hurt to ease up on the Old Spice, either.
The taste of deprivation
At one time or another, you’ve probably seen someone who was pretty much physically attached to his or her phone and wondered about the owner’s personal priorities and where the phone fit into them.
Wonder no more.
In a study conducted at the University at Buffalo (N.Y.), 76 students were deprived of food for 3 hours and their smartphones for 2 hours, and then given a computer task that would earn them a serving of their favorite snack or use of their phone. To make things more interesting, the amount of work needed to earn food or phone time increased as the subjects completed their tasks.
“We knew that students would be motivated to gain access to their phones, but we were surprised that, despite modest food deprivation, smartphone reinforcement far exceeded food reinforcement,” lead investigator Sara O’Donnell said in a written statement.
Recruiting subjects for the next step in this line of research – choosing between phones and breathing – could get a little tricky. But we have to admire the creative solution that got one participant disqualified from the current study: He tried to eat his phone.
Mylan issues voluntary recall of certain valsartan-containing products
Mylan has announced that it is voluntarily recalling 15 lots of products containing valsartan because of the detection of trace amounts of N-nitrosodiethylamine within the active ingredient, according to a company announcement posted on the website of the Food and Drug Administration.
The affected products include six lots of amlodipine/valsartan tablets (5-mg/160-mg, 10-mg/160-mg, and 10-mg/320-mg strengths), seven lots of valsartan tablets (40-mg, 80-mg, 160-mg, and 320-mg strengths), and two lots of valsartan/hydrochlorothiazide tablets (320-mg/25-mg strength). All products were distributed between March 2017 and November 2018.
“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the company statement said.
N-nitrosodiethylamine is a naturally occurring substance that has been identified as a human carcinogen by the International Agency for Research on Cancer.
The lot and NDC (National Drug Code) numbers of the affected products can be found in the full press release on the FDA website.
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday, 8 a.m. to 5 p.m. EST, according to the statement.
Mylan has announced that it is voluntarily recalling 15 lots of products containing valsartan because of the detection of trace amounts of N-nitrosodiethylamine within the active ingredient, according to a company announcement posted on the website of the Food and Drug Administration.
The affected products include six lots of amlodipine/valsartan tablets (5-mg/160-mg, 10-mg/160-mg, and 10-mg/320-mg strengths), seven lots of valsartan tablets (40-mg, 80-mg, 160-mg, and 320-mg strengths), and two lots of valsartan/hydrochlorothiazide tablets (320-mg/25-mg strength). All products were distributed between March 2017 and November 2018.
“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the company statement said.
N-nitrosodiethylamine is a naturally occurring substance that has been identified as a human carcinogen by the International Agency for Research on Cancer.
The lot and NDC (National Drug Code) numbers of the affected products can be found in the full press release on the FDA website.
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday, 8 a.m. to 5 p.m. EST, according to the statement.
Mylan has announced that it is voluntarily recalling 15 lots of products containing valsartan because of the detection of trace amounts of N-nitrosodiethylamine within the active ingredient, according to a company announcement posted on the website of the Food and Drug Administration.
The affected products include six lots of amlodipine/valsartan tablets (5-mg/160-mg, 10-mg/160-mg, and 10-mg/320-mg strengths), seven lots of valsartan tablets (40-mg, 80-mg, 160-mg, and 320-mg strengths), and two lots of valsartan/hydrochlorothiazide tablets (320-mg/25-mg strength). All products were distributed between March 2017 and November 2018.
“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the company statement said.
N-nitrosodiethylamine is a naturally occurring substance that has been identified as a human carcinogen by the International Agency for Research on Cancer.
The lot and NDC (National Drug Code) numbers of the affected products can be found in the full press release on the FDA website.
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Normal business hours are Monday through Friday, 8 a.m. to 5 p.m. EST, according to the statement.