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CDC awards $1.2 million to learn about people with sickle cell disease
The Centers for Disease Control and Prevention will be awarding $1.2 million in funding to help states collect data on issues faced by people with sickle cell disease.
Currently, only Georgia and California work with the CDC on the Sickle Cell Data Collection program to gather population-based, comprehensive health information about people with sickle cell disease. The new funding will expand that base to nine states. The money will go toward a 1-year project that will build infrastructure for recipient sites to gather unique data and conduct in-depth analyses in people with sickle cell disease, the CDC noted.
The sites that were awarded funding are Duke University, Durham, N.C.; Georgia State University, Atlanta; the Indiana Hemophilia and Thrombosis Center in Indianapolis; the Michigan Department of Health & Human Services; the Minnesota Department of Health; the Public Health Institute in Oakland, Calif.; the University of Alabama at Birmingham; the University of Tennessee Health Science Center in Memphis; and the Virginia Department of Health.
“Data is vital to informing new treatments and clinical care that will improve the lives of people affected by sickle cell disease. This new funding expands CDC’s partner network across the country which will accelerate efforts to ensure sickle cell patients live longer and healthier lives,” said CDC Director Robert R. Redfield, MD.
Find the full press release on the CDC website.
The Centers for Disease Control and Prevention will be awarding $1.2 million in funding to help states collect data on issues faced by people with sickle cell disease.
Currently, only Georgia and California work with the CDC on the Sickle Cell Data Collection program to gather population-based, comprehensive health information about people with sickle cell disease. The new funding will expand that base to nine states. The money will go toward a 1-year project that will build infrastructure for recipient sites to gather unique data and conduct in-depth analyses in people with sickle cell disease, the CDC noted.
The sites that were awarded funding are Duke University, Durham, N.C.; Georgia State University, Atlanta; the Indiana Hemophilia and Thrombosis Center in Indianapolis; the Michigan Department of Health & Human Services; the Minnesota Department of Health; the Public Health Institute in Oakland, Calif.; the University of Alabama at Birmingham; the University of Tennessee Health Science Center in Memphis; and the Virginia Department of Health.
“Data is vital to informing new treatments and clinical care that will improve the lives of people affected by sickle cell disease. This new funding expands CDC’s partner network across the country which will accelerate efforts to ensure sickle cell patients live longer and healthier lives,” said CDC Director Robert R. Redfield, MD.
Find the full press release on the CDC website.
The Centers for Disease Control and Prevention will be awarding $1.2 million in funding to help states collect data on issues faced by people with sickle cell disease.
Currently, only Georgia and California work with the CDC on the Sickle Cell Data Collection program to gather population-based, comprehensive health information about people with sickle cell disease. The new funding will expand that base to nine states. The money will go toward a 1-year project that will build infrastructure for recipient sites to gather unique data and conduct in-depth analyses in people with sickle cell disease, the CDC noted.
The sites that were awarded funding are Duke University, Durham, N.C.; Georgia State University, Atlanta; the Indiana Hemophilia and Thrombosis Center in Indianapolis; the Michigan Department of Health & Human Services; the Minnesota Department of Health; the Public Health Institute in Oakland, Calif.; the University of Alabama at Birmingham; the University of Tennessee Health Science Center in Memphis; and the Virginia Department of Health.
“Data is vital to informing new treatments and clinical care that will improve the lives of people affected by sickle cell disease. This new funding expands CDC’s partner network across the country which will accelerate efforts to ensure sickle cell patients live longer and healthier lives,” said CDC Director Robert R. Redfield, MD.
Find the full press release on the CDC website.
Acting FDA commissioner issues remarks on ENDS, vaping illnesses
Norman E. Sharpless, MD, acting commissioner of the Food and Drug Administration, has issued remarks that were prepared for a testimony before a U.S. House Energy and Commerce subcommittee on FDA regulation of electronic nicotine delivery systems and investigation of vaping illnesses.
Dr. Sharpless’s statement focuses on two priorities: the continuing investigation into the cause of lung injury associated with the use of vaping products and the FDA’s ongoing efforts to address an epidemic of youth use of electronic nicotine delivery systems (ENDS). In regards to lung injuries associated with vaping, Dr. Sharpless said that the FDA and Centers for Disease Control and Prevention, in conjunction with state partners, have been investigating the outbreak and noted that, while most cases have involved tetrahydrocannabinol, there is as of yet no common cause or product linked to all cases.
The FDA is not currently pursuing any legal action against personal usage of vaping products, but “if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” Dr. Sharpless said.
Research from the 2018 and 2019 National Youth Tobacco Surveys has indicated that ENDS usage among youth has risen dramatically in recent years, Dr. Sharpless continued in the statement. The FDA has pursued several courses of action, including the issue of a warning letter to Juul for marketing unauthorized modified-risk tobacco products to children.
However, he noted, youth e-cigarette use continues to rise, which is the reason for the FDA’s intention to finalize a compliance policy related to flavored ENDS, a policy supported by President TRump.
“FDA is not ‘banning’ flavors, as has been described in some news reports. Rather, FDA intends to enforce existing law that limits the marketing of such products,” Dr. Sharpless said. “This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.”
Find the full statement on the FDA website.
Norman E. Sharpless, MD, acting commissioner of the Food and Drug Administration, has issued remarks that were prepared for a testimony before a U.S. House Energy and Commerce subcommittee on FDA regulation of electronic nicotine delivery systems and investigation of vaping illnesses.
Dr. Sharpless’s statement focuses on two priorities: the continuing investigation into the cause of lung injury associated with the use of vaping products and the FDA’s ongoing efforts to address an epidemic of youth use of electronic nicotine delivery systems (ENDS). In regards to lung injuries associated with vaping, Dr. Sharpless said that the FDA and Centers for Disease Control and Prevention, in conjunction with state partners, have been investigating the outbreak and noted that, while most cases have involved tetrahydrocannabinol, there is as of yet no common cause or product linked to all cases.
The FDA is not currently pursuing any legal action against personal usage of vaping products, but “if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” Dr. Sharpless said.
Research from the 2018 and 2019 National Youth Tobacco Surveys has indicated that ENDS usage among youth has risen dramatically in recent years, Dr. Sharpless continued in the statement. The FDA has pursued several courses of action, including the issue of a warning letter to Juul for marketing unauthorized modified-risk tobacco products to children.
However, he noted, youth e-cigarette use continues to rise, which is the reason for the FDA’s intention to finalize a compliance policy related to flavored ENDS, a policy supported by President TRump.
“FDA is not ‘banning’ flavors, as has been described in some news reports. Rather, FDA intends to enforce existing law that limits the marketing of such products,” Dr. Sharpless said. “This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.”
Find the full statement on the FDA website.
Norman E. Sharpless, MD, acting commissioner of the Food and Drug Administration, has issued remarks that were prepared for a testimony before a U.S. House Energy and Commerce subcommittee on FDA regulation of electronic nicotine delivery systems and investigation of vaping illnesses.
Dr. Sharpless’s statement focuses on two priorities: the continuing investigation into the cause of lung injury associated with the use of vaping products and the FDA’s ongoing efforts to address an epidemic of youth use of electronic nicotine delivery systems (ENDS). In regards to lung injuries associated with vaping, Dr. Sharpless said that the FDA and Centers for Disease Control and Prevention, in conjunction with state partners, have been investigating the outbreak and noted that, while most cases have involved tetrahydrocannabinol, there is as of yet no common cause or product linked to all cases.
The FDA is not currently pursuing any legal action against personal usage of vaping products, but “if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” Dr. Sharpless said.
Research from the 2018 and 2019 National Youth Tobacco Surveys has indicated that ENDS usage among youth has risen dramatically in recent years, Dr. Sharpless continued in the statement. The FDA has pursued several courses of action, including the issue of a warning letter to Juul for marketing unauthorized modified-risk tobacco products to children.
However, he noted, youth e-cigarette use continues to rise, which is the reason for the FDA’s intention to finalize a compliance policy related to flavored ENDS, a policy supported by President TRump.
“FDA is not ‘banning’ flavors, as has been described in some news reports. Rather, FDA intends to enforce existing law that limits the marketing of such products,” Dr. Sharpless said. “This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale.”
Find the full statement on the FDA website.
FDA approves oral semaglutide for HbA1c management in type 2 diabetes
The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.
The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.
The Food and Drug Administration has approved semaglutide (Rybelsus) tablets for the treatment of type 2 diabetes in adults who have not met their hemoglobin A1c goal. It is the first glucagonlike peptide–1 (GLP-1) analogue to be approved in pill form in the United States.
The approval was based on results from the PIONEER trials, a series of 10 studies that assessed semaglutide against sitagliptin, empagliflozin, and liraglutide in a total of 9,543 patients with type 2 diabetes. Patients who received semaglutide had reduced hemoglobin A1c levels as well as reduced body weight.
The most common adverse events reported during the PIONEER trials were nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. The rate of adverse events were similar across trials.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized, in part because until now, they have been available only as an injectable treatment. The availability of an oral GLP-1 receptor agonist represents a significant development, and primary care providers, specialists, and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals,” said Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women’s Hospital in Boston and PIONEER clinical trial researcher.
Semaglutide is approved for once-daily use, at doses of 7 mg and 14 mg. Find the full press release on the Novo Nordisk website.
FDA grants sirolimus-eluting balloon breakthrough device designation for PAD
The Food and Drug Administration has granted the Breakthrough Device Designation to the Virtue sirolimus-eluting balloon (SEB) for below-the-knee peripheral arterial disease, according to a statement from Orchestra BioMed.
According to the FDA, this designation indicates that the Virtue SEB could provide a “more effective treatment option ... for a life-threatening or irreversibly debilitating disease”; as the release notes, below-the-knee atherosclerosis presents a high rate of amputation and poor survival outcomes but has limited treatment options. The designation leads to expedited development, assessment, and review.
Darren R. Sherman, president, CEO, and cofounder of Orchestra BioMed, noted that the Virtue SEB “has the potential to improve long-term outcomes and reduce periprocedural complications” that can “extend hospital stay and increase cost of treatment.” The system had previously received this designation for coronary in-stent restenosis based upon the 3-year results of the European SABRE trial.
The Food and Drug Administration has granted the Breakthrough Device Designation to the Virtue sirolimus-eluting balloon (SEB) for below-the-knee peripheral arterial disease, according to a statement from Orchestra BioMed.
According to the FDA, this designation indicates that the Virtue SEB could provide a “more effective treatment option ... for a life-threatening or irreversibly debilitating disease”; as the release notes, below-the-knee atherosclerosis presents a high rate of amputation and poor survival outcomes but has limited treatment options. The designation leads to expedited development, assessment, and review.
Darren R. Sherman, president, CEO, and cofounder of Orchestra BioMed, noted that the Virtue SEB “has the potential to improve long-term outcomes and reduce periprocedural complications” that can “extend hospital stay and increase cost of treatment.” The system had previously received this designation for coronary in-stent restenosis based upon the 3-year results of the European SABRE trial.
The Food and Drug Administration has granted the Breakthrough Device Designation to the Virtue sirolimus-eluting balloon (SEB) for below-the-knee peripheral arterial disease, according to a statement from Orchestra BioMed.
According to the FDA, this designation indicates that the Virtue SEB could provide a “more effective treatment option ... for a life-threatening or irreversibly debilitating disease”; as the release notes, below-the-knee atherosclerosis presents a high rate of amputation and poor survival outcomes but has limited treatment options. The designation leads to expedited development, assessment, and review.
Darren R. Sherman, president, CEO, and cofounder of Orchestra BioMed, noted that the Virtue SEB “has the potential to improve long-term outcomes and reduce periprocedural complications” that can “extend hospital stay and increase cost of treatment.” The system had previously received this designation for coronary in-stent restenosis based upon the 3-year results of the European SABRE trial.
FDA approves pembrolizumab/lenvatinib combo for advanced endometrial carcinoma
The Food and Drug Administration has granted accelerated approval to a pembrolizumab (Keytruda) plus lenvatinib (Lenvima) combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
The approval was based on results of KEYNOTE-146, a single-arm, multicenter, open-label, multicohort trial with 108 patients with metastatic endometrial carcinoma; 94 of these were not microsatellite instability high or mismatch repair deficient. The objective response rate in those 94 patients was 38.3% (95% confidence interval, 29%-49%), with 10 complete responses and 26 partial responses. The median duration of response was not reached over the trial period, and 69% of those who responded had a response duration of at least 6 months.
The most common adverse events reported during the trial were fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
The recommended dosage is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.
The Food and Drug Administration has granted accelerated approval to a pembrolizumab (Keytruda) plus lenvatinib (Lenvima) combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
The approval was based on results of KEYNOTE-146, a single-arm, multicenter, open-label, multicohort trial with 108 patients with metastatic endometrial carcinoma; 94 of these were not microsatellite instability high or mismatch repair deficient. The objective response rate in those 94 patients was 38.3% (95% confidence interval, 29%-49%), with 10 complete responses and 26 partial responses. The median duration of response was not reached over the trial period, and 69% of those who responded had a response duration of at least 6 months.
The most common adverse events reported during the trial were fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
The recommended dosage is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.
The Food and Drug Administration has granted accelerated approval to a pembrolizumab (Keytruda) plus lenvatinib (Lenvima) combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
The approval was based on results of KEYNOTE-146, a single-arm, multicenter, open-label, multicohort trial with 108 patients with metastatic endometrial carcinoma; 94 of these were not microsatellite instability high or mismatch repair deficient. The objective response rate in those 94 patients was 38.3% (95% confidence interval, 29%-49%), with 10 complete responses and 26 partial responses. The median duration of response was not reached over the trial period, and 69% of those who responded had a response duration of at least 6 months.
The most common adverse events reported during the trial were fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
The recommended dosage is lenvatinib 20 mg orally once daily with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks, according to the FDA.
NDMA found in samples of ranitidine, FDA says
According to the Food and Drug Administration,
“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”
Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”
She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.
Visit the AGA GI Patient Center for education to share with your patients about GERD, including symptoms, testing, lifestyle modifications and drug treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.
According to the Food and Drug Administration,
“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”
Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”
She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.
Visit the AGA GI Patient Center for education to share with your patients about GERD, including symptoms, testing, lifestyle modifications and drug treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.
According to the Food and Drug Administration,
“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”
Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”
She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.
Visit the AGA GI Patient Center for education to share with your patients about GERD, including symptoms, testing, lifestyle modifications and drug treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.
FDA issues warning for CDK 4/6 inhibitors
The Food and Drug Administration is warning that the entire class of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used to treat advanced breast cancer may cause rare but severe inflammation of the lungs.
“We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities,” the FDA said in a press statement.
The overall benefit of CDK 4/6 inhibitors, however, is still greater than the risks when used as prescribed, the agency said.
CDK 4/6 inhibitors are used in combination with hormone therapies to treat adults with hormone receptor–positive, human epidermal growth factor 2–negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA approved the CDK 4/6 inhibitors palbociclib (Ibrance) in 2015 and ribociclib (Kisqali) and abemaciclib (Verzenio) in 2017, based on improvements in progression-free survival.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis, the FDA said.
The Food and Drug Administration is warning that the entire class of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used to treat advanced breast cancer may cause rare but severe inflammation of the lungs.
“We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities,” the FDA said in a press statement.
The overall benefit of CDK 4/6 inhibitors, however, is still greater than the risks when used as prescribed, the agency said.
CDK 4/6 inhibitors are used in combination with hormone therapies to treat adults with hormone receptor–positive, human epidermal growth factor 2–negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA approved the CDK 4/6 inhibitors palbociclib (Ibrance) in 2015 and ribociclib (Kisqali) and abemaciclib (Verzenio) in 2017, based on improvements in progression-free survival.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis, the FDA said.
The Food and Drug Administration is warning that the entire class of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used to treat advanced breast cancer may cause rare but severe inflammation of the lungs.
“We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities,” the FDA said in a press statement.
The overall benefit of CDK 4/6 inhibitors, however, is still greater than the risks when used as prescribed, the agency said.
CDK 4/6 inhibitors are used in combination with hormone therapies to treat adults with hormone receptor–positive, human epidermal growth factor 2–negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA approved the CDK 4/6 inhibitors palbociclib (Ibrance) in 2015 and ribociclib (Kisqali) and abemaciclib (Verzenio) in 2017, based on improvements in progression-free survival.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis, the FDA said.
Measles cases continue to decline
according to the Centers for Disease Control and Prevention.
A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.
With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.
The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.
according to the Centers for Disease Control and Prevention.
A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.
With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.
The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.
according to the Centers for Disease Control and Prevention.
A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.
With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.
The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.
FDA issues warning to JUUL on illegal marketing of e-cigarettes
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
FDA approves nintedanib for scleroderma interstitial lung disease
The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.
Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.
The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.
The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.
The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.
Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.
The full release is available on the FDA website.
The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.
Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.
The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.
The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.
The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.
Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.
The full release is available on the FDA website.
The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.
Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.
The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.
The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.
The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.
Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.
The full release is available on the FDA website.