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FDA panel slams Endologix response to stent-graft safety issues
The Food and Drug Administration has long kept a watchful eye over successive iterations of endovascular stent graphs in the Endologix AFX line, designed for repair of abdominal aortic aneurysms (AAA). For years, the devices, first approved in 2011, have drawn safety alerts and recalls , stemming from what the agency says was a “higher than expected” risk for potentially injurious or fatal type III endoleaks.
As part of the latest review process, Endologix recently showed regulators data from a rare randomized trial of the AAA endovascular aneurysm repair (EVAR) technique. The company said the recent postmarket study LEOPARD suggested the type III endoleaks – blood seeping around or through the device into the aneurysm – are no more common with the current AFX2 system than with other available AAA stent-grafts.
Technical upgrades to its AFX line of EVAR devices in recent years have largely resolved the safety issues identified in previous models, the company argued.
But the company’s case was unconvincing for a majority of the FDA Circulatory System Devices Advisory Panel that assembled virtually on Nov. 2. A number of panelists questioned the earnestness with which Endologix worked to rectify the safety alert and recall issues. Many also decried the real-world relevance of the randomized trial presented as evidence, with its follow-up time of only a few years.
The panel that included more than a dozen clinicians – mostly surgeons or interventional cardiologists or radiologists – were not instructed to formally vote on the issues. But it ultimately advised the FDA that more exacting studies with longer follow-ups appear needed to show that the device’s benefits in routine use outweigh its risks, especially for type III endoleaks.
“There isn’t a tremendous amount of confidence” that Endologix had enacted sufficient risk-mitigation measures in the wake of the safety alerts and recalls, chair Richard A. Lange, MD, MBA, Foster School of Medicine and Texas Tech University Health Sciences Center, El Paso, said when summarizing the panel’s take on the day’s proceedings.
Although the stent-graft’s safety seemed improved with recent design changes, the panel wasn’t convinced the upgrades could take the credit, or even that they were aimed specifically at preventing endoleaks, Dr. Lange said. “Nobody feels assurance that the problem has been solved.”
“I believe that the type-three endoleaks pose a challenge to patients, and I have not seen enough data to assure me with a degree of certainty that that problem no longer persists,” said panelist Joaquin E. Cigarroa, MD, a cardiologist at Oregon Health & Science University, Portland. His take on the LEOPARD trial, moreover, is that it “does not refute that there is an issue, given the duration of follow-up.”
On the other hand, a majority of the panel agreed that, currently, the AFX2’s benefits would likely outweigh risks for patients in narrowly defined high-risk anatomic or clinical scenarios and those with no other endovascular or surgical option.
“I do believe that there are patient subsets where the Endologix graft can play an important and vital role,” surgeon Keith B. Allen, MD, St. Luke’s Mid America Heart & Vascular Institute, Kansas City, Missouri, offered from the panel.
“In patients that don’t have aneurysmal disease but have distal bifurcation proximal iliac disease, it can be a very nice graft to use and solves a problem,” he said. “To remove that graft completely from the market, I believe, would deny a subset of patients.”
But for aortic aneurysms in routine practice, Dr. Allen said, “I think there are some red flags with it.”
Joining the day’s proceedings as a public commenter, surgeon Mark Conrad, MD, St. Elizabeth’s Hospital, Boston, agreed that “there’s not one commercial device out there that is able to handle every anatomy.”
Having options for patients is important, he said, because “the biggest problems we run into are when somebody only uses one graft, and they try to make that fit everything.”
Another public commenter offered a similar take. “I think we haven’t done a great job in the vascular surgery community really honing in on the detailed nuances that separate one device from another,” said Naiem Nassiri, MD, Yale New Haven Hospital Heart & Vascular Center, Connecticut.
The Endologix device, he said, “serves a very specific role under certain anatomic configurations and limitations, and really, truly fills a gap” left by other available grafts. It suits a very specific niche, “and I think it needs to be explored further for that.”
Endologix representatives who advise clinicians could play a better role in familiarizing operators with the EVAR system’s strengths and limitations, proposed several panelists, including Minhaj S. Khaja, MD, MBA, interventional radiologist at UVA Health and the University of Virginia, Charlottesville.
“There definitely needs to be more education of the clinical reps as well as the physicians implanting these devices,” he said, regarding the type III leaks, patient selection issues, appropriate imaging follow-up, “and the potential for increased reintervention.”
All public commenters, Dr. Lange observed, had been invited to disclose potential conflicts of interest, but it was not mandatory and none did so during the public forum. Disclosures of potential conflicts for the panelists are available on the FDA site.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has long kept a watchful eye over successive iterations of endovascular stent graphs in the Endologix AFX line, designed for repair of abdominal aortic aneurysms (AAA). For years, the devices, first approved in 2011, have drawn safety alerts and recalls , stemming from what the agency says was a “higher than expected” risk for potentially injurious or fatal type III endoleaks.
As part of the latest review process, Endologix recently showed regulators data from a rare randomized trial of the AAA endovascular aneurysm repair (EVAR) technique. The company said the recent postmarket study LEOPARD suggested the type III endoleaks – blood seeping around or through the device into the aneurysm – are no more common with the current AFX2 system than with other available AAA stent-grafts.
Technical upgrades to its AFX line of EVAR devices in recent years have largely resolved the safety issues identified in previous models, the company argued.
But the company’s case was unconvincing for a majority of the FDA Circulatory System Devices Advisory Panel that assembled virtually on Nov. 2. A number of panelists questioned the earnestness with which Endologix worked to rectify the safety alert and recall issues. Many also decried the real-world relevance of the randomized trial presented as evidence, with its follow-up time of only a few years.
The panel that included more than a dozen clinicians – mostly surgeons or interventional cardiologists or radiologists – were not instructed to formally vote on the issues. But it ultimately advised the FDA that more exacting studies with longer follow-ups appear needed to show that the device’s benefits in routine use outweigh its risks, especially for type III endoleaks.
“There isn’t a tremendous amount of confidence” that Endologix had enacted sufficient risk-mitigation measures in the wake of the safety alerts and recalls, chair Richard A. Lange, MD, MBA, Foster School of Medicine and Texas Tech University Health Sciences Center, El Paso, said when summarizing the panel’s take on the day’s proceedings.
Although the stent-graft’s safety seemed improved with recent design changes, the panel wasn’t convinced the upgrades could take the credit, or even that they were aimed specifically at preventing endoleaks, Dr. Lange said. “Nobody feels assurance that the problem has been solved.”
“I believe that the type-three endoleaks pose a challenge to patients, and I have not seen enough data to assure me with a degree of certainty that that problem no longer persists,” said panelist Joaquin E. Cigarroa, MD, a cardiologist at Oregon Health & Science University, Portland. His take on the LEOPARD trial, moreover, is that it “does not refute that there is an issue, given the duration of follow-up.”
On the other hand, a majority of the panel agreed that, currently, the AFX2’s benefits would likely outweigh risks for patients in narrowly defined high-risk anatomic or clinical scenarios and those with no other endovascular or surgical option.
“I do believe that there are patient subsets where the Endologix graft can play an important and vital role,” surgeon Keith B. Allen, MD, St. Luke’s Mid America Heart & Vascular Institute, Kansas City, Missouri, offered from the panel.
“In patients that don’t have aneurysmal disease but have distal bifurcation proximal iliac disease, it can be a very nice graft to use and solves a problem,” he said. “To remove that graft completely from the market, I believe, would deny a subset of patients.”
But for aortic aneurysms in routine practice, Dr. Allen said, “I think there are some red flags with it.”
Joining the day’s proceedings as a public commenter, surgeon Mark Conrad, MD, St. Elizabeth’s Hospital, Boston, agreed that “there’s not one commercial device out there that is able to handle every anatomy.”
Having options for patients is important, he said, because “the biggest problems we run into are when somebody only uses one graft, and they try to make that fit everything.”
Another public commenter offered a similar take. “I think we haven’t done a great job in the vascular surgery community really honing in on the detailed nuances that separate one device from another,” said Naiem Nassiri, MD, Yale New Haven Hospital Heart & Vascular Center, Connecticut.
The Endologix device, he said, “serves a very specific role under certain anatomic configurations and limitations, and really, truly fills a gap” left by other available grafts. It suits a very specific niche, “and I think it needs to be explored further for that.”
Endologix representatives who advise clinicians could play a better role in familiarizing operators with the EVAR system’s strengths and limitations, proposed several panelists, including Minhaj S. Khaja, MD, MBA, interventional radiologist at UVA Health and the University of Virginia, Charlottesville.
“There definitely needs to be more education of the clinical reps as well as the physicians implanting these devices,” he said, regarding the type III leaks, patient selection issues, appropriate imaging follow-up, “and the potential for increased reintervention.”
All public commenters, Dr. Lange observed, had been invited to disclose potential conflicts of interest, but it was not mandatory and none did so during the public forum. Disclosures of potential conflicts for the panelists are available on the FDA site.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has long kept a watchful eye over successive iterations of endovascular stent graphs in the Endologix AFX line, designed for repair of abdominal aortic aneurysms (AAA). For years, the devices, first approved in 2011, have drawn safety alerts and recalls , stemming from what the agency says was a “higher than expected” risk for potentially injurious or fatal type III endoleaks.
As part of the latest review process, Endologix recently showed regulators data from a rare randomized trial of the AAA endovascular aneurysm repair (EVAR) technique. The company said the recent postmarket study LEOPARD suggested the type III endoleaks – blood seeping around or through the device into the aneurysm – are no more common with the current AFX2 system than with other available AAA stent-grafts.
Technical upgrades to its AFX line of EVAR devices in recent years have largely resolved the safety issues identified in previous models, the company argued.
But the company’s case was unconvincing for a majority of the FDA Circulatory System Devices Advisory Panel that assembled virtually on Nov. 2. A number of panelists questioned the earnestness with which Endologix worked to rectify the safety alert and recall issues. Many also decried the real-world relevance of the randomized trial presented as evidence, with its follow-up time of only a few years.
The panel that included more than a dozen clinicians – mostly surgeons or interventional cardiologists or radiologists – were not instructed to formally vote on the issues. But it ultimately advised the FDA that more exacting studies with longer follow-ups appear needed to show that the device’s benefits in routine use outweigh its risks, especially for type III endoleaks.
“There isn’t a tremendous amount of confidence” that Endologix had enacted sufficient risk-mitigation measures in the wake of the safety alerts and recalls, chair Richard A. Lange, MD, MBA, Foster School of Medicine and Texas Tech University Health Sciences Center, El Paso, said when summarizing the panel’s take on the day’s proceedings.
Although the stent-graft’s safety seemed improved with recent design changes, the panel wasn’t convinced the upgrades could take the credit, or even that they were aimed specifically at preventing endoleaks, Dr. Lange said. “Nobody feels assurance that the problem has been solved.”
“I believe that the type-three endoleaks pose a challenge to patients, and I have not seen enough data to assure me with a degree of certainty that that problem no longer persists,” said panelist Joaquin E. Cigarroa, MD, a cardiologist at Oregon Health & Science University, Portland. His take on the LEOPARD trial, moreover, is that it “does not refute that there is an issue, given the duration of follow-up.”
On the other hand, a majority of the panel agreed that, currently, the AFX2’s benefits would likely outweigh risks for patients in narrowly defined high-risk anatomic or clinical scenarios and those with no other endovascular or surgical option.
“I do believe that there are patient subsets where the Endologix graft can play an important and vital role,” surgeon Keith B. Allen, MD, St. Luke’s Mid America Heart & Vascular Institute, Kansas City, Missouri, offered from the panel.
“In patients that don’t have aneurysmal disease but have distal bifurcation proximal iliac disease, it can be a very nice graft to use and solves a problem,” he said. “To remove that graft completely from the market, I believe, would deny a subset of patients.”
But for aortic aneurysms in routine practice, Dr. Allen said, “I think there are some red flags with it.”
Joining the day’s proceedings as a public commenter, surgeon Mark Conrad, MD, St. Elizabeth’s Hospital, Boston, agreed that “there’s not one commercial device out there that is able to handle every anatomy.”
Having options for patients is important, he said, because “the biggest problems we run into are when somebody only uses one graft, and they try to make that fit everything.”
Another public commenter offered a similar take. “I think we haven’t done a great job in the vascular surgery community really honing in on the detailed nuances that separate one device from another,” said Naiem Nassiri, MD, Yale New Haven Hospital Heart & Vascular Center, Connecticut.
The Endologix device, he said, “serves a very specific role under certain anatomic configurations and limitations, and really, truly fills a gap” left by other available grafts. It suits a very specific niche, “and I think it needs to be explored further for that.”
Endologix representatives who advise clinicians could play a better role in familiarizing operators with the EVAR system’s strengths and limitations, proposed several panelists, including Minhaj S. Khaja, MD, MBA, interventional radiologist at UVA Health and the University of Virginia, Charlottesville.
“There definitely needs to be more education of the clinical reps as well as the physicians implanting these devices,” he said, regarding the type III leaks, patient selection issues, appropriate imaging follow-up, “and the potential for increased reintervention.”
All public commenters, Dr. Lange observed, had been invited to disclose potential conflicts of interest, but it was not mandatory and none did so during the public forum. Disclosures of potential conflicts for the panelists are available on the FDA site.
A version of this article first appeared on Medscape.com.
Expected spike in acute flaccid myelitis did not occur in 2020
suggested researchers at the Centers for Disease Control and Prevention.
Acute flaccid myelitis (AFM) is an uncommon but serious complication of some viral infections, including West Nile virus and nonpolio enteroviruses. It is “characterized by sudden onset of limb weakness and lesions in the gray matter of the spinal cord,” they said, and more than 90% of cases occur in young children.
Cases of AFM, which can lead to respiratory insufficiency and permanent paralysis, spiked during the late summer and early fall in 2014, 2016, and 2018 and were expected to do so again in 2020, Sarah Kidd, MD, and associates at the division of viral diseases at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said in the Morbidity and Mortality Weekly Report.
Monthly peaks in those previous years – each occurring in September – reached 51 cases in 2014, 43 cases in 2016, and 88 cases in 2018, but in 2020 there was only 1 case reported in September, with a high of 4 coming in May, CDC data show. The total number of cases for 2020 (32) was, in fact, lower than in 2019, when 47 were reported.
The investigators’ main objective was to see if there were any differences between the 2018 and 2019-2020 cases. Reports from state health departments to the CDC showed that, in 2019-2020, “patients were older; more likely to have lower limb involvement; and less likely to have upper limb involvement, prodromal illness, [cerebrospinal fluid] pleocytosis, or specimens that tested positive for EV [enterovirus]-D68” than patients from 2018, Dr. Kidd and associates said.
Mask wearing and reduced in-school attendance may have decreased circulation of EV-D68 – the enterovirus type most often detected in the stool and respiratory specimens of AFM patients – as was seen with other respiratory viruses, such as influenza and respiratory syncytial virus, in 2020. Previous studies have suggested that EV-D68 drives the increases in cases during peak years, the researchers noted.
The absence of such an increase “in 2020 reflects a deviation from the previously observed biennial pattern, and it is unclear when the next increase in AFM should be expected. Clinicians should continue to maintain vigilance and suspect AFM in any child with acute flaccid limb weakness, particularly in the setting of recent febrile or respiratory illness,” they wrote.
suggested researchers at the Centers for Disease Control and Prevention.
Acute flaccid myelitis (AFM) is an uncommon but serious complication of some viral infections, including West Nile virus and nonpolio enteroviruses. It is “characterized by sudden onset of limb weakness and lesions in the gray matter of the spinal cord,” they said, and more than 90% of cases occur in young children.
Cases of AFM, which can lead to respiratory insufficiency and permanent paralysis, spiked during the late summer and early fall in 2014, 2016, and 2018 and were expected to do so again in 2020, Sarah Kidd, MD, and associates at the division of viral diseases at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said in the Morbidity and Mortality Weekly Report.
Monthly peaks in those previous years – each occurring in September – reached 51 cases in 2014, 43 cases in 2016, and 88 cases in 2018, but in 2020 there was only 1 case reported in September, with a high of 4 coming in May, CDC data show. The total number of cases for 2020 (32) was, in fact, lower than in 2019, when 47 were reported.
The investigators’ main objective was to see if there were any differences between the 2018 and 2019-2020 cases. Reports from state health departments to the CDC showed that, in 2019-2020, “patients were older; more likely to have lower limb involvement; and less likely to have upper limb involvement, prodromal illness, [cerebrospinal fluid] pleocytosis, or specimens that tested positive for EV [enterovirus]-D68” than patients from 2018, Dr. Kidd and associates said.
Mask wearing and reduced in-school attendance may have decreased circulation of EV-D68 – the enterovirus type most often detected in the stool and respiratory specimens of AFM patients – as was seen with other respiratory viruses, such as influenza and respiratory syncytial virus, in 2020. Previous studies have suggested that EV-D68 drives the increases in cases during peak years, the researchers noted.
The absence of such an increase “in 2020 reflects a deviation from the previously observed biennial pattern, and it is unclear when the next increase in AFM should be expected. Clinicians should continue to maintain vigilance and suspect AFM in any child with acute flaccid limb weakness, particularly in the setting of recent febrile or respiratory illness,” they wrote.
suggested researchers at the Centers for Disease Control and Prevention.
Acute flaccid myelitis (AFM) is an uncommon but serious complication of some viral infections, including West Nile virus and nonpolio enteroviruses. It is “characterized by sudden onset of limb weakness and lesions in the gray matter of the spinal cord,” they said, and more than 90% of cases occur in young children.
Cases of AFM, which can lead to respiratory insufficiency and permanent paralysis, spiked during the late summer and early fall in 2014, 2016, and 2018 and were expected to do so again in 2020, Sarah Kidd, MD, and associates at the division of viral diseases at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said in the Morbidity and Mortality Weekly Report.
Monthly peaks in those previous years – each occurring in September – reached 51 cases in 2014, 43 cases in 2016, and 88 cases in 2018, but in 2020 there was only 1 case reported in September, with a high of 4 coming in May, CDC data show. The total number of cases for 2020 (32) was, in fact, lower than in 2019, when 47 were reported.
The investigators’ main objective was to see if there were any differences between the 2018 and 2019-2020 cases. Reports from state health departments to the CDC showed that, in 2019-2020, “patients were older; more likely to have lower limb involvement; and less likely to have upper limb involvement, prodromal illness, [cerebrospinal fluid] pleocytosis, or specimens that tested positive for EV [enterovirus]-D68” than patients from 2018, Dr. Kidd and associates said.
Mask wearing and reduced in-school attendance may have decreased circulation of EV-D68 – the enterovirus type most often detected in the stool and respiratory specimens of AFM patients – as was seen with other respiratory viruses, such as influenza and respiratory syncytial virus, in 2020. Previous studies have suggested that EV-D68 drives the increases in cases during peak years, the researchers noted.
The absence of such an increase “in 2020 reflects a deviation from the previously observed biennial pattern, and it is unclear when the next increase in AFM should be expected. Clinicians should continue to maintain vigilance and suspect AFM in any child with acute flaccid limb weakness, particularly in the setting of recent febrile or respiratory illness,” they wrote.
FROM MMWR
New single-button blood glucose monitor available in U.S.
The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.
It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.
An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.
“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.
“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
How does POGO compare with CGM?
Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.
Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”
“Patients also need to obtain a prescription in order to use CGM.”
“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.
The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.
The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.
The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.
A version of this article first appeared on Medscape.com.
The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.
It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.
An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.
“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.
“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
How does POGO compare with CGM?
Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.
Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”
“Patients also need to obtain a prescription in order to use CGM.”
“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.
The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.
The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.
The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.
A version of this article first appeared on Medscape.com.
The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.
It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.
An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.
“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.
“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
How does POGO compare with CGM?
Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.
Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”
“Patients also need to obtain a prescription in order to use CGM.”
“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.
The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.
The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.
The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.
A version of this article first appeared on Medscape.com.
CDC endorses Pfizer’s COVID-19 vaccine for young kids
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
FDA class I recall of CardioSave hybrid/rescue IABPs
Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.
The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.
If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.
Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.
Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.
“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.
The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.
The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.
Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.
The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.
Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.
All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.
Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.
Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article first appeared on Medscape.com.
Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.
The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.
If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.
Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.
Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.
“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.
The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.
The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.
Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.
The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.
Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.
All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.
Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.
Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article first appeared on Medscape.com.
Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.
The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.
If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.
Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.
Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.
“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.
The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.
The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.
Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.
The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.
Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.
All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.
Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.
Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article first appeared on Medscape.com.
COVID-19 vaccines provide 5 times the protection of natural immunity, CDC study says
, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
FDA authorizes Pfizer’s COVID-19 vaccine for kids
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.
States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.
As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the United States between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.
A version of this article first appeared on WebMD.com.
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.
States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.
As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the United States between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.
A version of this article first appeared on WebMD.com.
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.
States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.
As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the United States between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.
A version of this article first appeared on WebMD.com.
FDA posts new websites on accelerated approvals for cancer drugs
, including a public list detailing cases where accelerated approvals have been rescinded for lack of evidence.
On Oct. 29, the Food and Drug Administration posted new websites detailing the status of oncology medicines given these special clearances:
- Ongoing | Cancer Accelerated Approvals
- Verified Clinical Benefit | Cancer Accelerated Approvals
- Withdrawn | Cancer Accelerated Approvals
The FDA’s cancer center also has created a web page called Project Confirm to provide more information on the way it uses accelerated approvals.
There has been increased concern about medicines cleared by accelerated approvals in recent years, culminating in an uproar over the controversial June approval of aducanumab (Aduhelm) for Alzheimer’s disease. This drew more attention to a debate already underway about how much data supports some of the indications for some cancer drugs.
Federal and state officials and advisers are putting more pressure on pharmaceutical companies to prove that medicines that are put on the market through accelerated approval do deliver meaningful benefits for patients.
In addition, earlier this month two of the top health advisers in Barack Obama’s administration proposed a new model through which Medicare could reduce payments for certain cancer drugs cleared through accelerated approvals – and even cut off reimbursements in cases where companies fail to deliver confirmatory evidence for expected benefits.
This “Pay for Drugs That Work Model” was proposed by Richard Frank, PhD, and Ezekiel Emanuel, MD, PhD, in a recent JAMA article. In their view, the FDA’s accelerated drug approval process allows for too many delays in obtaining answers as to whether medicines cleared this way provide expected benefits.
“The proposed Pay for Drugs That Work model could test a modified approach for incentivizing rapid completion of confirmatory trials to inform clinicians and patients about the true risks and benefits of new drugs and improve the value for money of cancer drugs that receive accelerated approval,” they wrote.
Excel files, regular updates
For the FDA, accelerated approvals require balancing an estimated potential benefit for people facing serious diseases (for example, cancer) against serious risks, including potentially exposing patients to costly, toxic drugs that will later be shown not to work for their conditions.
For many years, there has been significant pressure on the FDA to lean toward speedier approvals, with members of Congress, advocacy groups, and drugmakers advocating for broad use of surrogate data in deciding on clearances. The FDA posts biannual reports on its website that highlight how quickly approvals have been granted. But these biannual reports don’t provide much information on the status of accelerated-approval drugs, other than to say if they have been given full approval or withdrawn.
The newly created websites from the FDA’s oncology division appear to reflect growing public interest in knowing what standards the agency sets for confirmatory trials and what deadlines companies face to deliver evidence of significant benefit for their drugs.
The new sortable websites also include details on trials and have links to Excel files which will help researchers and others seeking to track patterns with accelerated approvals. The FDA said in an interview that it intends to update these sites when there are developments with accelerated approvals for cancer drugs, such as new clearances of this type, conversions to regular approvals, and withdrawn approvals.
Julia Beaver, MD, chief of medical oncology at the FDA’s Oncology Center of Excellence, and acting deputy director of the Office of Oncologic Diseases of the FDA’s Center for Drug Evaluation and Research, described the new websites as part of a “commitment to preserve the integrity” of the accelerated approval program.
“These new web pages will make information on our accelerated approvals more transparent,” Dr. Beaver said in an email to this news organization.
The FDA has been able to speed many medicines to market and clear additional uses for drugs already sold through the program, giving people earlier access in many cases to critical medicines, Dr. Beaver said.
More than 165 oncology indications have received accelerated approval, with almost half converted to regular approval in a median of 3 years. Less than 10% of these indications were withdrawn, Dr. Beaver said.
“Of those accelerated approvals that were converted to regular approval, many demonstrated survival advantages to patients with several types of cancer or provided meaningful therapeutic options where none previously existed,” she said.
However, Dr. Beaver also has made public the FDA’s concerns with what she and Richard Pazdur, MD, director of the Oncology Center of Excellence, have described as “dangling” accelerated approvals.
These are cases where the required trials did not end up confirming benefit for a medicine, yet the manufacturer did not move to withdraw an accelerated approval. The FDA’s cancer center has already announced that it is doing an “industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials did not confirm clinical benefit.”
This stems in part from what can be called the FDA’s “growing pains” in its efforts to manage the rapidly changing landscape for these immunotherapy checkpoint inhibitors. This field of medicine has experienced an “unprecedented level of drug development” in recent years, FDA officials said in briefing materials for an Oncologic Drugs Advisory Committee (ODAC) meeting last April on dangling accelerated approvals.
A newly posted chart on withdrawn oncology accelerated approvals, posted by the FDA’s cancer division, makes it clear that the pace of these rescinded clearances has picked up. The chart lists a total 14 withdrawn indications of oncology accelerated approvals.
Six of these withdrawals happened this year.
There were two withdrawals in 2020, including the December withdrawal of nivolumab, (Opdivo) for a form of metastatic lung cancer.
Then there was a significant gap, with no withdrawals going back to 2013 (when there was one). There were two withdrawals in 2012 and three in 2011.
A version of this article first appeared on Medscape.com.
, including a public list detailing cases where accelerated approvals have been rescinded for lack of evidence.
On Oct. 29, the Food and Drug Administration posted new websites detailing the status of oncology medicines given these special clearances:
- Ongoing | Cancer Accelerated Approvals
- Verified Clinical Benefit | Cancer Accelerated Approvals
- Withdrawn | Cancer Accelerated Approvals
The FDA’s cancer center also has created a web page called Project Confirm to provide more information on the way it uses accelerated approvals.
There has been increased concern about medicines cleared by accelerated approvals in recent years, culminating in an uproar over the controversial June approval of aducanumab (Aduhelm) for Alzheimer’s disease. This drew more attention to a debate already underway about how much data supports some of the indications for some cancer drugs.
Federal and state officials and advisers are putting more pressure on pharmaceutical companies to prove that medicines that are put on the market through accelerated approval do deliver meaningful benefits for patients.
In addition, earlier this month two of the top health advisers in Barack Obama’s administration proposed a new model through which Medicare could reduce payments for certain cancer drugs cleared through accelerated approvals – and even cut off reimbursements in cases where companies fail to deliver confirmatory evidence for expected benefits.
This “Pay for Drugs That Work Model” was proposed by Richard Frank, PhD, and Ezekiel Emanuel, MD, PhD, in a recent JAMA article. In their view, the FDA’s accelerated drug approval process allows for too many delays in obtaining answers as to whether medicines cleared this way provide expected benefits.
“The proposed Pay for Drugs That Work model could test a modified approach for incentivizing rapid completion of confirmatory trials to inform clinicians and patients about the true risks and benefits of new drugs and improve the value for money of cancer drugs that receive accelerated approval,” they wrote.
Excel files, regular updates
For the FDA, accelerated approvals require balancing an estimated potential benefit for people facing serious diseases (for example, cancer) against serious risks, including potentially exposing patients to costly, toxic drugs that will later be shown not to work for their conditions.
For many years, there has been significant pressure on the FDA to lean toward speedier approvals, with members of Congress, advocacy groups, and drugmakers advocating for broad use of surrogate data in deciding on clearances. The FDA posts biannual reports on its website that highlight how quickly approvals have been granted. But these biannual reports don’t provide much information on the status of accelerated-approval drugs, other than to say if they have been given full approval or withdrawn.
The newly created websites from the FDA’s oncology division appear to reflect growing public interest in knowing what standards the agency sets for confirmatory trials and what deadlines companies face to deliver evidence of significant benefit for their drugs.
The new sortable websites also include details on trials and have links to Excel files which will help researchers and others seeking to track patterns with accelerated approvals. The FDA said in an interview that it intends to update these sites when there are developments with accelerated approvals for cancer drugs, such as new clearances of this type, conversions to regular approvals, and withdrawn approvals.
Julia Beaver, MD, chief of medical oncology at the FDA’s Oncology Center of Excellence, and acting deputy director of the Office of Oncologic Diseases of the FDA’s Center for Drug Evaluation and Research, described the new websites as part of a “commitment to preserve the integrity” of the accelerated approval program.
“These new web pages will make information on our accelerated approvals more transparent,” Dr. Beaver said in an email to this news organization.
The FDA has been able to speed many medicines to market and clear additional uses for drugs already sold through the program, giving people earlier access in many cases to critical medicines, Dr. Beaver said.
More than 165 oncology indications have received accelerated approval, with almost half converted to regular approval in a median of 3 years. Less than 10% of these indications were withdrawn, Dr. Beaver said.
“Of those accelerated approvals that were converted to regular approval, many demonstrated survival advantages to patients with several types of cancer or provided meaningful therapeutic options where none previously existed,” she said.
However, Dr. Beaver also has made public the FDA’s concerns with what she and Richard Pazdur, MD, director of the Oncology Center of Excellence, have described as “dangling” accelerated approvals.
These are cases where the required trials did not end up confirming benefit for a medicine, yet the manufacturer did not move to withdraw an accelerated approval. The FDA’s cancer center has already announced that it is doing an “industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials did not confirm clinical benefit.”
This stems in part from what can be called the FDA’s “growing pains” in its efforts to manage the rapidly changing landscape for these immunotherapy checkpoint inhibitors. This field of medicine has experienced an “unprecedented level of drug development” in recent years, FDA officials said in briefing materials for an Oncologic Drugs Advisory Committee (ODAC) meeting last April on dangling accelerated approvals.
A newly posted chart on withdrawn oncology accelerated approvals, posted by the FDA’s cancer division, makes it clear that the pace of these rescinded clearances has picked up. The chart lists a total 14 withdrawn indications of oncology accelerated approvals.
Six of these withdrawals happened this year.
There were two withdrawals in 2020, including the December withdrawal of nivolumab, (Opdivo) for a form of metastatic lung cancer.
Then there was a significant gap, with no withdrawals going back to 2013 (when there was one). There were two withdrawals in 2012 and three in 2011.
A version of this article first appeared on Medscape.com.
, including a public list detailing cases where accelerated approvals have been rescinded for lack of evidence.
On Oct. 29, the Food and Drug Administration posted new websites detailing the status of oncology medicines given these special clearances:
- Ongoing | Cancer Accelerated Approvals
- Verified Clinical Benefit | Cancer Accelerated Approvals
- Withdrawn | Cancer Accelerated Approvals
The FDA’s cancer center also has created a web page called Project Confirm to provide more information on the way it uses accelerated approvals.
There has been increased concern about medicines cleared by accelerated approvals in recent years, culminating in an uproar over the controversial June approval of aducanumab (Aduhelm) for Alzheimer’s disease. This drew more attention to a debate already underway about how much data supports some of the indications for some cancer drugs.
Federal and state officials and advisers are putting more pressure on pharmaceutical companies to prove that medicines that are put on the market through accelerated approval do deliver meaningful benefits for patients.
In addition, earlier this month two of the top health advisers in Barack Obama’s administration proposed a new model through which Medicare could reduce payments for certain cancer drugs cleared through accelerated approvals – and even cut off reimbursements in cases where companies fail to deliver confirmatory evidence for expected benefits.
This “Pay for Drugs That Work Model” was proposed by Richard Frank, PhD, and Ezekiel Emanuel, MD, PhD, in a recent JAMA article. In their view, the FDA’s accelerated drug approval process allows for too many delays in obtaining answers as to whether medicines cleared this way provide expected benefits.
“The proposed Pay for Drugs That Work model could test a modified approach for incentivizing rapid completion of confirmatory trials to inform clinicians and patients about the true risks and benefits of new drugs and improve the value for money of cancer drugs that receive accelerated approval,” they wrote.
Excel files, regular updates
For the FDA, accelerated approvals require balancing an estimated potential benefit for people facing serious diseases (for example, cancer) against serious risks, including potentially exposing patients to costly, toxic drugs that will later be shown not to work for their conditions.
For many years, there has been significant pressure on the FDA to lean toward speedier approvals, with members of Congress, advocacy groups, and drugmakers advocating for broad use of surrogate data in deciding on clearances. The FDA posts biannual reports on its website that highlight how quickly approvals have been granted. But these biannual reports don’t provide much information on the status of accelerated-approval drugs, other than to say if they have been given full approval or withdrawn.
The newly created websites from the FDA’s oncology division appear to reflect growing public interest in knowing what standards the agency sets for confirmatory trials and what deadlines companies face to deliver evidence of significant benefit for their drugs.
The new sortable websites also include details on trials and have links to Excel files which will help researchers and others seeking to track patterns with accelerated approvals. The FDA said in an interview that it intends to update these sites when there are developments with accelerated approvals for cancer drugs, such as new clearances of this type, conversions to regular approvals, and withdrawn approvals.
Julia Beaver, MD, chief of medical oncology at the FDA’s Oncology Center of Excellence, and acting deputy director of the Office of Oncologic Diseases of the FDA’s Center for Drug Evaluation and Research, described the new websites as part of a “commitment to preserve the integrity” of the accelerated approval program.
“These new web pages will make information on our accelerated approvals more transparent,” Dr. Beaver said in an email to this news organization.
The FDA has been able to speed many medicines to market and clear additional uses for drugs already sold through the program, giving people earlier access in many cases to critical medicines, Dr. Beaver said.
More than 165 oncology indications have received accelerated approval, with almost half converted to regular approval in a median of 3 years. Less than 10% of these indications were withdrawn, Dr. Beaver said.
“Of those accelerated approvals that were converted to regular approval, many demonstrated survival advantages to patients with several types of cancer or provided meaningful therapeutic options where none previously existed,” she said.
However, Dr. Beaver also has made public the FDA’s concerns with what she and Richard Pazdur, MD, director of the Oncology Center of Excellence, have described as “dangling” accelerated approvals.
These are cases where the required trials did not end up confirming benefit for a medicine, yet the manufacturer did not move to withdraw an accelerated approval. The FDA’s cancer center has already announced that it is doing an “industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials did not confirm clinical benefit.”
This stems in part from what can be called the FDA’s “growing pains” in its efforts to manage the rapidly changing landscape for these immunotherapy checkpoint inhibitors. This field of medicine has experienced an “unprecedented level of drug development” in recent years, FDA officials said in briefing materials for an Oncologic Drugs Advisory Committee (ODAC) meeting last April on dangling accelerated approvals.
A newly posted chart on withdrawn oncology accelerated approvals, posted by the FDA’s cancer division, makes it clear that the pace of these rescinded clearances has picked up. The chart lists a total 14 withdrawn indications of oncology accelerated approvals.
Six of these withdrawals happened this year.
There were two withdrawals in 2020, including the December withdrawal of nivolumab, (Opdivo) for a form of metastatic lung cancer.
Then there was a significant gap, with no withdrawals going back to 2013 (when there was one). There were two withdrawals in 2012 and three in 2011.
A version of this article first appeared on Medscape.com.
FDA issues stronger safety requirements for breast implants
The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.
“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”
This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).
Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.
In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:
- A patient-decision checklist
- Updated silicone gel–filled breast implant rupture screening recommendations
- A device description including materials used in the device
- Patient device ID cards
The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.
The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”
Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.
To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.
But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.
“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”
This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).
Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.
In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:
- A patient-decision checklist
- Updated silicone gel–filled breast implant rupture screening recommendations
- A device description including materials used in the device
- Patient device ID cards
The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.
The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”
Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.
To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.
But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Oct. 27 announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning – the strongest warning that the FDA requires – on all legally marketed breast implants.
“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”
This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel–filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel–filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).
Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery, with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.
In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. The Oct. 27 FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:
- A patient-decision checklist
- Updated silicone gel–filled breast implant rupture screening recommendations
- A device description including materials used in the device
- Patient device ID cards
The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.
The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to this news organization, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said that “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”
Maria Gmitro, president and cofounder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, S.C., said that some of the language in the patient checklist could be stronger, especially when referring to breast implant–associated ALCL.
To inform patients of risks more clearly, “it’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.
But overall, the nonprofit was “thrilled” with the announcement, Ms. Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts. This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”
A version of this article first appeared on Medscape.com.
CDC: Urgency remains to vaccinate children
The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.
On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.
“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”
CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.
As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.
But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.
“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.
Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.
In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.
A version of this article first appeared on WebMD.com.
The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.
On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.
“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”
CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.
As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.
But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.
“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.
Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.
In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.
A version of this article first appeared on WebMD.com.
The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.
On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.
“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”
CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.
As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.
But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.
“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.
Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.
In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.
A version of this article first appeared on WebMD.com.