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‘Antibacterial’ soap labels still list banned ingredients
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
FDA issues public health warning recommending against cesium salt usage
The Food and Drug Administration has issued a public health alert warning consumers to avoid the use of dietary supplements that contain cesium chloride or any other cesium salt because of significant safety risks.
Cesium salts are sometimes advertised as an alternative treatment for cancer, the FDA said in the announcement, but these salts have never proved to be safe or effective at treating cancer or any other disease. Clinical case reports and nonclinical trials have shown that cesium salts are associated with a variety of adverse events, including cardiac arrhythmias, hypokalemia, seizures, syncope, and death.
The FDA warned health care providers that cesium salts presented a significant safety risk in compounding drugs in July 2018.
Health care providers should not recommend dietary supplements containing cesium salts to their patients, the FDA said, and if a patient experiences an adverse event while taking a supplement containing cesium salt, the event should be reported to the agency.
While there are few dietary supplements on the market that contain cesium salt, consumers should be aware of the risks and avoid these products. The FDA noted that “if claims sound too good to be true, they probably are.”
The Food and Drug Administration has issued a public health alert warning consumers to avoid the use of dietary supplements that contain cesium chloride or any other cesium salt because of significant safety risks.
Cesium salts are sometimes advertised as an alternative treatment for cancer, the FDA said in the announcement, but these salts have never proved to be safe or effective at treating cancer or any other disease. Clinical case reports and nonclinical trials have shown that cesium salts are associated with a variety of adverse events, including cardiac arrhythmias, hypokalemia, seizures, syncope, and death.
The FDA warned health care providers that cesium salts presented a significant safety risk in compounding drugs in July 2018.
Health care providers should not recommend dietary supplements containing cesium salts to their patients, the FDA said, and if a patient experiences an adverse event while taking a supplement containing cesium salt, the event should be reported to the agency.
While there are few dietary supplements on the market that contain cesium salt, consumers should be aware of the risks and avoid these products. The FDA noted that “if claims sound too good to be true, they probably are.”
The Food and Drug Administration has issued a public health alert warning consumers to avoid the use of dietary supplements that contain cesium chloride or any other cesium salt because of significant safety risks.
Cesium salts are sometimes advertised as an alternative treatment for cancer, the FDA said in the announcement, but these salts have never proved to be safe or effective at treating cancer or any other disease. Clinical case reports and nonclinical trials have shown that cesium salts are associated with a variety of adverse events, including cardiac arrhythmias, hypokalemia, seizures, syncope, and death.
The FDA warned health care providers that cesium salts presented a significant safety risk in compounding drugs in July 2018.
Health care providers should not recommend dietary supplements containing cesium salts to their patients, the FDA said, and if a patient experiences an adverse event while taking a supplement containing cesium salt, the event should be reported to the agency.
While there are few dietary supplements on the market that contain cesium salt, consumers should be aware of the risks and avoid these products. The FDA noted that “if claims sound too good to be true, they probably are.”
FDA approves novel pandemic influenza vaccine
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
Expanded indication for leadless pacemaker triples eligible patients
The U.S. Food and Drug Administration’s approval of an expanded indication for a leadless pacemaker for patients “who may benefit from maintenance of atrioventricular synchrony” will make this technology potentially available to nearly half of the Americans who need a pacemaker, roughly triple the number of patients who have been candidates for a leadless pacemaker up to now.
“This approval was huge. The complication rate with leadless pacemakers has been 63% less than the rate using pacemakers with transvenous leads,” said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication. By expanding the types of patients suitable for leadless pacing “we’ll achieve AV [atrioventricular] synchrony in more patients with fewer complications,” said Dr. Chinitz, professor of medicine and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health in New York.
Because the device is both leadless and requires no pocket owing to its small size and placement in a patient’s right ventricle, it has implications for potentially broadening the population that could benefit from the device, he said in an interview. “When we started with this pacemaker, it was limited to elderly patients with persistent atrial fibrillation who needed only ventricular pacing, a very small group,” just under 15% of the universe of patients who need pacemakers. The broadened indication, for patients with high-grade AV block who also have atrial function, makes it possible to think of using this safer and easier-to-place device in patients who need infrequent pacing, and in patients with multiple comorbidities that give them an increased complication risk, he said. The new indication means “you’re treating a much broader patient population, doing it more safely, and creating the foundation for expanding this technology.”
The Micra AV pacemaker uses the same basic design as the previously approved Micra Transcatheter Pacing System, which came onto the U.S. market in 2016 and provides single-chamber pacing. An accelerometer on the device allows it to detect atrial motion and thereby synchronize ventricular and atrial contractions, which led to the new indication. Although the Micra AV device looks similar to the original single-chamber model, it has an entirely new circuitry that prolongs battery life during dual-chamber pacing as well as new software that incorporates the accelerometer data, explained Robert Kowal, MD, a cardiac electrophysiologist, and vice president of medical affairs and chief medical officer of cardiac rhythm and heart failure at Medtronic in Minneapolis. The battery of the Micra AV is designed to last about 15 years, Dr. Chinitz noted.
Results from two studies that Dr. Chinitz helped run established the safety and efficacy of the device for dual-chamber pacing. The MARVEL (Micra Atrial Tracking Using a Ventricular Accelerometer) study included 64 patients who completed the study at 12 worldwide centers, which produced an average 80% AV synchrony in 33 patients with high-degree AV block (The other patients in the study had predominantly intrinsic AV conduction; Heart Rhythm. 2018 Sep;15[9]:1363-71). The MARVEL 2 study included 75 patients with either second- or third-degree AV block at 12 worldwide centers and showed that AV synchrony increased from an average of 27% without two-chamber pacing to 89% with the dual-chamber function turned on, and with 95% of patients achieving at least 70% AV synchrony (JACC Clin Electrophysiol. 2020 Jan;6[1]:94-106).
The 2016 indication for single-chamber pacing included patients with “high-grade” AV bloc with or without atrial fibrillation, typically patients for whom dual-chamber pacemaker was not a great option because of the risks for complication but with the downside of limited AV synchrony, a limitation now mitigated by the option of mechanical synchronization, Dr. Kowal said. The AV device remains intended for patients with high-grade AV node block, which means patients with second- or third-degree block, he added in an interview. The estimated prevalence of third-degree AV block among U.S. adults is about 0.02%, which translates into about 50,000 people; the estimated prevalence of second-degree AV block is much less, about 10% of the third-degree prevalence.
Despite the substantial cut in complications by a leadless and pocketless pacemaker, “some patients may still benefit from a traditional dual-chamber pacemaker,” specifically active patients who might sometimes get their heart rates up with exercise to levels of about 150 beats/min or higher, Dr. Kowal said. That’s because currently the programing algorithms used to synchronize the ventricle and atrium become less reliable at heart rates above 105 beats/min, he explained. However, the ability for mechanical synchronization to keep up at higher heart rates should improve as additional data are collected that can refine the algorithms. It’s also unusual for most patients who are pacemaker candidates to reach heart rates this high, he said.
The MARVEL and MARVEL 2 studies were sponsored by Medtronic, the company that markets Micra pacemakers. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer, and he has also received fellowship support from Biotronik and Boston Scientific. Dr. Kowal is a Medtronic employee.
The U.S. Food and Drug Administration’s approval of an expanded indication for a leadless pacemaker for patients “who may benefit from maintenance of atrioventricular synchrony” will make this technology potentially available to nearly half of the Americans who need a pacemaker, roughly triple the number of patients who have been candidates for a leadless pacemaker up to now.
“This approval was huge. The complication rate with leadless pacemakers has been 63% less than the rate using pacemakers with transvenous leads,” said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication. By expanding the types of patients suitable for leadless pacing “we’ll achieve AV [atrioventricular] synchrony in more patients with fewer complications,” said Dr. Chinitz, professor of medicine and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health in New York.
Because the device is both leadless and requires no pocket owing to its small size and placement in a patient’s right ventricle, it has implications for potentially broadening the population that could benefit from the device, he said in an interview. “When we started with this pacemaker, it was limited to elderly patients with persistent atrial fibrillation who needed only ventricular pacing, a very small group,” just under 15% of the universe of patients who need pacemakers. The broadened indication, for patients with high-grade AV block who also have atrial function, makes it possible to think of using this safer and easier-to-place device in patients who need infrequent pacing, and in patients with multiple comorbidities that give them an increased complication risk, he said. The new indication means “you’re treating a much broader patient population, doing it more safely, and creating the foundation for expanding this technology.”
The Micra AV pacemaker uses the same basic design as the previously approved Micra Transcatheter Pacing System, which came onto the U.S. market in 2016 and provides single-chamber pacing. An accelerometer on the device allows it to detect atrial motion and thereby synchronize ventricular and atrial contractions, which led to the new indication. Although the Micra AV device looks similar to the original single-chamber model, it has an entirely new circuitry that prolongs battery life during dual-chamber pacing as well as new software that incorporates the accelerometer data, explained Robert Kowal, MD, a cardiac electrophysiologist, and vice president of medical affairs and chief medical officer of cardiac rhythm and heart failure at Medtronic in Minneapolis. The battery of the Micra AV is designed to last about 15 years, Dr. Chinitz noted.
Results from two studies that Dr. Chinitz helped run established the safety and efficacy of the device for dual-chamber pacing. The MARVEL (Micra Atrial Tracking Using a Ventricular Accelerometer) study included 64 patients who completed the study at 12 worldwide centers, which produced an average 80% AV synchrony in 33 patients with high-degree AV block (The other patients in the study had predominantly intrinsic AV conduction; Heart Rhythm. 2018 Sep;15[9]:1363-71). The MARVEL 2 study included 75 patients with either second- or third-degree AV block at 12 worldwide centers and showed that AV synchrony increased from an average of 27% without two-chamber pacing to 89% with the dual-chamber function turned on, and with 95% of patients achieving at least 70% AV synchrony (JACC Clin Electrophysiol. 2020 Jan;6[1]:94-106).
The 2016 indication for single-chamber pacing included patients with “high-grade” AV bloc with or without atrial fibrillation, typically patients for whom dual-chamber pacemaker was not a great option because of the risks for complication but with the downside of limited AV synchrony, a limitation now mitigated by the option of mechanical synchronization, Dr. Kowal said. The AV device remains intended for patients with high-grade AV node block, which means patients with second- or third-degree block, he added in an interview. The estimated prevalence of third-degree AV block among U.S. adults is about 0.02%, which translates into about 50,000 people; the estimated prevalence of second-degree AV block is much less, about 10% of the third-degree prevalence.
Despite the substantial cut in complications by a leadless and pocketless pacemaker, “some patients may still benefit from a traditional dual-chamber pacemaker,” specifically active patients who might sometimes get their heart rates up with exercise to levels of about 150 beats/min or higher, Dr. Kowal said. That’s because currently the programing algorithms used to synchronize the ventricle and atrium become less reliable at heart rates above 105 beats/min, he explained. However, the ability for mechanical synchronization to keep up at higher heart rates should improve as additional data are collected that can refine the algorithms. It’s also unusual for most patients who are pacemaker candidates to reach heart rates this high, he said.
The MARVEL and MARVEL 2 studies were sponsored by Medtronic, the company that markets Micra pacemakers. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer, and he has also received fellowship support from Biotronik and Boston Scientific. Dr. Kowal is a Medtronic employee.
The U.S. Food and Drug Administration’s approval of an expanded indication for a leadless pacemaker for patients “who may benefit from maintenance of atrioventricular synchrony” will make this technology potentially available to nearly half of the Americans who need a pacemaker, roughly triple the number of patients who have been candidates for a leadless pacemaker up to now.
“This approval was huge. The complication rate with leadless pacemakers has been 63% less than the rate using pacemakers with transvenous leads,” said Larry A. Chinitz, MD, a cardiac electrophysiologist and a coinvestigator on some of the studies that led to the new indication. By expanding the types of patients suitable for leadless pacing “we’ll achieve AV [atrioventricular] synchrony in more patients with fewer complications,” said Dr. Chinitz, professor of medicine and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health in New York.
Because the device is both leadless and requires no pocket owing to its small size and placement in a patient’s right ventricle, it has implications for potentially broadening the population that could benefit from the device, he said in an interview. “When we started with this pacemaker, it was limited to elderly patients with persistent atrial fibrillation who needed only ventricular pacing, a very small group,” just under 15% of the universe of patients who need pacemakers. The broadened indication, for patients with high-grade AV block who also have atrial function, makes it possible to think of using this safer and easier-to-place device in patients who need infrequent pacing, and in patients with multiple comorbidities that give them an increased complication risk, he said. The new indication means “you’re treating a much broader patient population, doing it more safely, and creating the foundation for expanding this technology.”
The Micra AV pacemaker uses the same basic design as the previously approved Micra Transcatheter Pacing System, which came onto the U.S. market in 2016 and provides single-chamber pacing. An accelerometer on the device allows it to detect atrial motion and thereby synchronize ventricular and atrial contractions, which led to the new indication. Although the Micra AV device looks similar to the original single-chamber model, it has an entirely new circuitry that prolongs battery life during dual-chamber pacing as well as new software that incorporates the accelerometer data, explained Robert Kowal, MD, a cardiac electrophysiologist, and vice president of medical affairs and chief medical officer of cardiac rhythm and heart failure at Medtronic in Minneapolis. The battery of the Micra AV is designed to last about 15 years, Dr. Chinitz noted.
Results from two studies that Dr. Chinitz helped run established the safety and efficacy of the device for dual-chamber pacing. The MARVEL (Micra Atrial Tracking Using a Ventricular Accelerometer) study included 64 patients who completed the study at 12 worldwide centers, which produced an average 80% AV synchrony in 33 patients with high-degree AV block (The other patients in the study had predominantly intrinsic AV conduction; Heart Rhythm. 2018 Sep;15[9]:1363-71). The MARVEL 2 study included 75 patients with either second- or third-degree AV block at 12 worldwide centers and showed that AV synchrony increased from an average of 27% without two-chamber pacing to 89% with the dual-chamber function turned on, and with 95% of patients achieving at least 70% AV synchrony (JACC Clin Electrophysiol. 2020 Jan;6[1]:94-106).
The 2016 indication for single-chamber pacing included patients with “high-grade” AV bloc with or without atrial fibrillation, typically patients for whom dual-chamber pacemaker was not a great option because of the risks for complication but with the downside of limited AV synchrony, a limitation now mitigated by the option of mechanical synchronization, Dr. Kowal said. The AV device remains intended for patients with high-grade AV node block, which means patients with second- or third-degree block, he added in an interview. The estimated prevalence of third-degree AV block among U.S. adults is about 0.02%, which translates into about 50,000 people; the estimated prevalence of second-degree AV block is much less, about 10% of the third-degree prevalence.
Despite the substantial cut in complications by a leadless and pocketless pacemaker, “some patients may still benefit from a traditional dual-chamber pacemaker,” specifically active patients who might sometimes get their heart rates up with exercise to levels of about 150 beats/min or higher, Dr. Kowal said. That’s because currently the programing algorithms used to synchronize the ventricle and atrium become less reliable at heart rates above 105 beats/min, he explained. However, the ability for mechanical synchronization to keep up at higher heart rates should improve as additional data are collected that can refine the algorithms. It’s also unusual for most patients who are pacemaker candidates to reach heart rates this high, he said.
The MARVEL and MARVEL 2 studies were sponsored by Medtronic, the company that markets Micra pacemakers. Dr. Chinitz has received fees and fellowship support from Medtronic, and has also received fees from Abbott, Biosense Webster, Biotronik, and Pfizer, and he has also received fellowship support from Biotronik and Boston Scientific. Dr. Kowal is a Medtronic employee.
FDA okays Palforzia, first drug for peanut allergy in children
The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.
The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.
Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.
An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.
The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.
Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.
The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.
‘Eagerly’ awaited
Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.
In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.
Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.
“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.
The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.
Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.
An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.
The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.
Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.
The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.
‘Eagerly’ awaited
Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.
In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.
Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.
“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.
The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.
Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.
An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.
The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.
Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.
The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.
‘Eagerly’ awaited
Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.
In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.
Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.
“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
This article first appeared on Medscape.com.
HHS declares coronavirus emergency, orders quarantine
The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.
"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*
2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.
“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”
These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”
The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”
* This story was updated on 01/31/2020.
The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.
"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*
2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.
“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”
These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”
The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”
* This story was updated on 01/31/2020.
The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.
"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*
2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.
“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”
These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”
The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”
* This story was updated on 01/31/2020.
FDA strengthens warning regarding clozapine, serious bowel complication risk
The Food and Drug Administration is strengthening a previous warning regarding the uncommon risk of serious bowel complications associated with the schizophrenia medication clozapine (Clozaril, FazaClo ODT, Versacloz).
According to the FDA press release, dated Jan. 28, clozapine affects bowel function in a majority of patients, and constipation is a common adverse event associated with clozapine use. This can uncommonly progress to serious bowel complications, including complete bowel blockage, and can result in hospitalization or even death if the constipation is not diagnosed and treated quickly.
Patients should contact their health care clinician if their bowel movements are less frequent, they have a bowel movement less than three times a week, they have hard or dry stool, or they have difficulty passing gas. Urgent care is needed if patients are experiencing nausea, vomiting, belly pain, or bloating, according to the FDA.
In addition, , avoid coprescribing with other anticholinergic medicines, advise and question patients about the risks of clozapine and their bowel movements, monitor patients for complications, and consider prophylactic laxative treatment in patients with a history of constipation or bowel obstruction, the FDA added.
The Food and Drug Administration is strengthening a previous warning regarding the uncommon risk of serious bowel complications associated with the schizophrenia medication clozapine (Clozaril, FazaClo ODT, Versacloz).
According to the FDA press release, dated Jan. 28, clozapine affects bowel function in a majority of patients, and constipation is a common adverse event associated with clozapine use. This can uncommonly progress to serious bowel complications, including complete bowel blockage, and can result in hospitalization or even death if the constipation is not diagnosed and treated quickly.
Patients should contact their health care clinician if their bowel movements are less frequent, they have a bowel movement less than three times a week, they have hard or dry stool, or they have difficulty passing gas. Urgent care is needed if patients are experiencing nausea, vomiting, belly pain, or bloating, according to the FDA.
In addition, , avoid coprescribing with other anticholinergic medicines, advise and question patients about the risks of clozapine and their bowel movements, monitor patients for complications, and consider prophylactic laxative treatment in patients with a history of constipation or bowel obstruction, the FDA added.
The Food and Drug Administration is strengthening a previous warning regarding the uncommon risk of serious bowel complications associated with the schizophrenia medication clozapine (Clozaril, FazaClo ODT, Versacloz).
According to the FDA press release, dated Jan. 28, clozapine affects bowel function in a majority of patients, and constipation is a common adverse event associated with clozapine use. This can uncommonly progress to serious bowel complications, including complete bowel blockage, and can result in hospitalization or even death if the constipation is not diagnosed and treated quickly.
Patients should contact their health care clinician if their bowel movements are less frequent, they have a bowel movement less than three times a week, they have hard or dry stool, or they have difficulty passing gas. Urgent care is needed if patients are experiencing nausea, vomiting, belly pain, or bloating, according to the FDA.
In addition, , avoid coprescribing with other anticholinergic medicines, advise and question patients about the risks of clozapine and their bowel movements, monitor patients for complications, and consider prophylactic laxative treatment in patients with a history of constipation or bowel obstruction, the FDA added.
FDA okays triple-combo pill for type 2 diabetes
Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.
“Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment,” Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.
All three drugs are separately well-established therapies for type 2 diabetes. Metformin is the most commonly prescribed treatment for type 2. Empagliflozin, a sodium-glucose transporter 2 inhibitor, and linagliptin, a single-dose dipeptidyl peptidase–4 inhibitor, are approved for the reduction of blood sugar in patients with type 2 disease, and empagliflozin is also approved for lowering the risk of cardiovascular death in adults with type 2 and established cardiovascular disease, according to the statement. (In 2015, the FDA approved a combination of empagliflozin and linagliptin, Glyxambi, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.)
The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.
Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.
As with empagliflozin and linagliptin alone, the combination therapy is not recommended for individuals with type 1 diabetes or diabetic ketoacidosis, and it has not been tested in patients with a history of pancreatitis. The combination also has a warning for lactic acidosis, a rare, but serious, condition that can arise with metformin accumulation.
The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.
Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.
“Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment,” Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.
All three drugs are separately well-established therapies for type 2 diabetes. Metformin is the most commonly prescribed treatment for type 2. Empagliflozin, a sodium-glucose transporter 2 inhibitor, and linagliptin, a single-dose dipeptidyl peptidase–4 inhibitor, are approved for the reduction of blood sugar in patients with type 2 disease, and empagliflozin is also approved for lowering the risk of cardiovascular death in adults with type 2 and established cardiovascular disease, according to the statement. (In 2015, the FDA approved a combination of empagliflozin and linagliptin, Glyxambi, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.)
The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.
Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.
As with empagliflozin and linagliptin alone, the combination therapy is not recommended for individuals with type 1 diabetes or diabetic ketoacidosis, and it has not been tested in patients with a history of pancreatitis. The combination also has a warning for lactic acidosis, a rare, but serious, condition that can arise with metformin accumulation.
The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.
Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.
“Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment,” Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.
All three drugs are separately well-established therapies for type 2 diabetes. Metformin is the most commonly prescribed treatment for type 2. Empagliflozin, a sodium-glucose transporter 2 inhibitor, and linagliptin, a single-dose dipeptidyl peptidase–4 inhibitor, are approved for the reduction of blood sugar in patients with type 2 disease, and empagliflozin is also approved for lowering the risk of cardiovascular death in adults with type 2 and established cardiovascular disease, according to the statement. (In 2015, the FDA approved a combination of empagliflozin and linagliptin, Glyxambi, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.)
The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.
Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.
As with empagliflozin and linagliptin alone, the combination therapy is not recommended for individuals with type 1 diabetes or diabetic ketoacidosis, and it has not been tested in patients with a history of pancreatitis. The combination also has a warning for lactic acidosis, a rare, but serious, condition that can arise with metformin accumulation.
The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.
FDA approves fidaxomicin for treatment of C. difficile–associated diarrhea
The Food and Drug Administration has approved fidaxomicin (Dificid) for the treatment of Clostridioides difficile–associated diarrhea in children aged 6 months and older.
Approval was based on results from SUNSHINE, a phase 3, multicenter, investigator-blind, randomized, parallel-group study in 142 pediatric patients aged between 6 months and 18 years with confirmed C. difficile infection who received either fidaxomicin or vancomycin for 10 days. Clinical response 2 days after the conclusion of treatment was similar in both groups (77.6% for fidaxomicin vs. 70.5% for vancomycin), and fidaxomicin had a superior sustained response 30 days after the conclusion of treatment (68.4% vs. 50.0%).
The safety of fidaxomicin was assessed in a pair of clinical trials involving 136 patients; the most common adverse events were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash. Four patients discontinued fidaxomicin treatment because of adverse events, and four patients died during the trials, though all deaths were in patients aged younger than 2 years and seemed to be related to other comorbidities.
“C. difficile is an important cause of health care– and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized, controlled trial of C. difficile infection treatment in children,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in the press release from Merck, manufacturer of fidaxomicin.
*This story was updated on 1/27/2020.
The Food and Drug Administration has approved fidaxomicin (Dificid) for the treatment of Clostridioides difficile–associated diarrhea in children aged 6 months and older.
Approval was based on results from SUNSHINE, a phase 3, multicenter, investigator-blind, randomized, parallel-group study in 142 pediatric patients aged between 6 months and 18 years with confirmed C. difficile infection who received either fidaxomicin or vancomycin for 10 days. Clinical response 2 days after the conclusion of treatment was similar in both groups (77.6% for fidaxomicin vs. 70.5% for vancomycin), and fidaxomicin had a superior sustained response 30 days after the conclusion of treatment (68.4% vs. 50.0%).
The safety of fidaxomicin was assessed in a pair of clinical trials involving 136 patients; the most common adverse events were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash. Four patients discontinued fidaxomicin treatment because of adverse events, and four patients died during the trials, though all deaths were in patients aged younger than 2 years and seemed to be related to other comorbidities.
“C. difficile is an important cause of health care– and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized, controlled trial of C. difficile infection treatment in children,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in the press release from Merck, manufacturer of fidaxomicin.
*This story was updated on 1/27/2020.
The Food and Drug Administration has approved fidaxomicin (Dificid) for the treatment of Clostridioides difficile–associated diarrhea in children aged 6 months and older.
Approval was based on results from SUNSHINE, a phase 3, multicenter, investigator-blind, randomized, parallel-group study in 142 pediatric patients aged between 6 months and 18 years with confirmed C. difficile infection who received either fidaxomicin or vancomycin for 10 days. Clinical response 2 days after the conclusion of treatment was similar in both groups (77.6% for fidaxomicin vs. 70.5% for vancomycin), and fidaxomicin had a superior sustained response 30 days after the conclusion of treatment (68.4% vs. 50.0%).
The safety of fidaxomicin was assessed in a pair of clinical trials involving 136 patients; the most common adverse events were pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash. Four patients discontinued fidaxomicin treatment because of adverse events, and four patients died during the trials, though all deaths were in patients aged younger than 2 years and seemed to be related to other comorbidities.
“C. difficile is an important cause of health care– and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized, controlled trial of C. difficile infection treatment in children,” Larry K. Kociolek, MD, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in the press release from Merck, manufacturer of fidaxomicin.
*This story was updated on 1/27/2020.
EVALI update warns of chemicals in vaping products
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
FROM MMWR