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FDA approves first IV migraine prevention drug
As previously reported by Medscape Medical News, the drug’s approval is based on results from two clinical studies – PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
The recommended dose is 100 mg every 3 months although some patients may benefit from a dose of 300 mg, the company notes. Lundbeck reports that the drug will likely be available in early April.
Roger Cady, MD, vice-president of neurology at Lundbeck, told Medscape Medical News the drug has almost immediate efficacy.
“Because it’s an IV [medication], it has very rapid benefit. In fact, we were able to demonstrate benefit on Day 1. Truly, it is going to impact on the unmet need for patients because of its profile, the way it’s delivered, and its uniqueness,” Cady said.
“Having preventive activity the day following an infusion is really important. We have in our data, if you take that time between the first day and the 28th day, whether they have episodic migraine or chronic migraine, that about 30% of the population had a 75% or more reduction in migraine days through that first month,” he added.
The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days, the company reports.
The safety of Vyepti was evaluated in 2076 patients with migraine who received at least one dose of the drug. The most common adverse reactions were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment as a result of adverse reactions.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter Goadsby, MD, professor of neurology at King’s College, London, UK, and the University of California, San Francisco, in a press release. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
This article first appeared on Medscape.com.
As previously reported by Medscape Medical News, the drug’s approval is based on results from two clinical studies – PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
The recommended dose is 100 mg every 3 months although some patients may benefit from a dose of 300 mg, the company notes. Lundbeck reports that the drug will likely be available in early April.
Roger Cady, MD, vice-president of neurology at Lundbeck, told Medscape Medical News the drug has almost immediate efficacy.
“Because it’s an IV [medication], it has very rapid benefit. In fact, we were able to demonstrate benefit on Day 1. Truly, it is going to impact on the unmet need for patients because of its profile, the way it’s delivered, and its uniqueness,” Cady said.
“Having preventive activity the day following an infusion is really important. We have in our data, if you take that time between the first day and the 28th day, whether they have episodic migraine or chronic migraine, that about 30% of the population had a 75% or more reduction in migraine days through that first month,” he added.
The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days, the company reports.
The safety of Vyepti was evaluated in 2076 patients with migraine who received at least one dose of the drug. The most common adverse reactions were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment as a result of adverse reactions.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter Goadsby, MD, professor of neurology at King’s College, London, UK, and the University of California, San Francisco, in a press release. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
This article first appeared on Medscape.com.
As previously reported by Medscape Medical News, the drug’s approval is based on results from two clinical studies – PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine.
The recommended dose is 100 mg every 3 months although some patients may benefit from a dose of 300 mg, the company notes. Lundbeck reports that the drug will likely be available in early April.
Roger Cady, MD, vice-president of neurology at Lundbeck, told Medscape Medical News the drug has almost immediate efficacy.
“Because it’s an IV [medication], it has very rapid benefit. In fact, we were able to demonstrate benefit on Day 1. Truly, it is going to impact on the unmet need for patients because of its profile, the way it’s delivered, and its uniqueness,” Cady said.
“Having preventive activity the day following an infusion is really important. We have in our data, if you take that time between the first day and the 28th day, whether they have episodic migraine or chronic migraine, that about 30% of the population had a 75% or more reduction in migraine days through that first month,” he added.
The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days, the company reports.
The safety of Vyepti was evaluated in 2076 patients with migraine who received at least one dose of the drug. The most common adverse reactions were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment as a result of adverse reactions.
“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Peter Goadsby, MD, professor of neurology at King’s College, London, UK, and the University of California, San Francisco, in a press release. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
This article first appeared on Medscape.com.
FROM MEDSCAPE.COM
FDA opens the door to biosimilar insulin
The Food and Drug Administration published Feb. 21 in the Federal Register a final rule that transitions insulin and other products from regulation as a drug to a biologic. This will provide manufacturers access to the biosimilars approval pathway and is expected to bring more competition to the insulin market. The move comes as insulin manufacturers continue to get increased scrutiny over the significantly increased pricing of their products in recent years.
The transition was required under a provision of the Biologics Price Competition and Innovation Act of 2009.
The move is expected to have no impact on the distribution of insulin and other products affected by the transition.
“In general, prescribers should continue to prescribe and order insulin and other biological products the same way they did before the transition,” the FDA said in an FAQ on the transition for physicians and other health care workers. “In general, pharmacists should continue to dispense and counsel about insulin and other biological products the same way they did before the transition. Prescribers and pharmacists should ensure their patients understand there are no changes to the product and they should continue to use the product the same way as before the transition.”
Other products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins. Information on all the transitioning products will move from the Orange Book (which lists FDA-approved drug products with therapeutic equivalent evaluations) to the Purple Book (which lists FDA-licensed biological products with reference product exclusivity data and biosimilar/interchangeability evaluations).
The FDA in the FAQ reiterated its commitment to reviewing any applications for these transition products within 12 months of submission.
The Food and Drug Administration published Feb. 21 in the Federal Register a final rule that transitions insulin and other products from regulation as a drug to a biologic. This will provide manufacturers access to the biosimilars approval pathway and is expected to bring more competition to the insulin market. The move comes as insulin manufacturers continue to get increased scrutiny over the significantly increased pricing of their products in recent years.
The transition was required under a provision of the Biologics Price Competition and Innovation Act of 2009.
The move is expected to have no impact on the distribution of insulin and other products affected by the transition.
“In general, prescribers should continue to prescribe and order insulin and other biological products the same way they did before the transition,” the FDA said in an FAQ on the transition for physicians and other health care workers. “In general, pharmacists should continue to dispense and counsel about insulin and other biological products the same way they did before the transition. Prescribers and pharmacists should ensure their patients understand there are no changes to the product and they should continue to use the product the same way as before the transition.”
Other products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins. Information on all the transitioning products will move from the Orange Book (which lists FDA-approved drug products with therapeutic equivalent evaluations) to the Purple Book (which lists FDA-licensed biological products with reference product exclusivity data and biosimilar/interchangeability evaluations).
The FDA in the FAQ reiterated its commitment to reviewing any applications for these transition products within 12 months of submission.
The Food and Drug Administration published Feb. 21 in the Federal Register a final rule that transitions insulin and other products from regulation as a drug to a biologic. This will provide manufacturers access to the biosimilars approval pathway and is expected to bring more competition to the insulin market. The move comes as insulin manufacturers continue to get increased scrutiny over the significantly increased pricing of their products in recent years.
The transition was required under a provision of the Biologics Price Competition and Innovation Act of 2009.
The move is expected to have no impact on the distribution of insulin and other products affected by the transition.
“In general, prescribers should continue to prescribe and order insulin and other biological products the same way they did before the transition,” the FDA said in an FAQ on the transition for physicians and other health care workers. “In general, pharmacists should continue to dispense and counsel about insulin and other biological products the same way they did before the transition. Prescribers and pharmacists should ensure their patients understand there are no changes to the product and they should continue to use the product the same way as before the transition.”
Other products affected by the transition include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins. Information on all the transitioning products will move from the Orange Book (which lists FDA-approved drug products with therapeutic equivalent evaluations) to the Purple Book (which lists FDA-licensed biological products with reference product exclusivity data and biosimilar/interchangeability evaluations).
The FDA in the FAQ reiterated its commitment to reviewing any applications for these transition products within 12 months of submission.
New lipid-lowering drug earns FDA approval
The Food and Drug Administration has approved bempedoic acid (Nexletol) for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL cholesterol lowering.
The oral adenosine triphosphate–citrate lyase (ACL) inhibitor is indicated as an adjunct to diet and maximally tolerated statin therapy in these patients, and approved at the 180 mg once daily dose, the agency announced today.
The safety and efficacy of bempedoic acid were demonstrated over 52 weeks in two multicenter randomized, clinical trials involving 3,009 adults with HeFH or established ASCVD on maximally tolerated statin therapy.
The difference between bempedoic acid and placebo for the primary outcome of change in LDL cholesterol from baseline to week 12 was –18% in the first trial, CLEAR Harmony (95% confidence interval, –20% to –16%; P less than .001), and –17% in the second trial, CLEAR Wisdom (95% CI, –21% to –14%; P less than .001).
The label notes that the effect on cardiovascular morbidity and mortality has not been determined. The label also includes warnings stating that bempedoic acid may increase blood uric acid levels and is associated with an increased risk of tendon rupture or injury.
In clinical trials, 26% of bempedoic acid–treated patients with normal baseline uric acid values versus 9.5% of placebo-treated patients experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction versus 1.1% with placebo, according to the label. Gout was reported in 1.5% of patients treated with bempedoic acid and 0.4% of those treated with placebo.
Also in clinical trials, the risk of tendon rupture was 0.5% with bempedoic acid and 0% with placebo. Tendon rupture involved the rotator cuff, biceps tendon, or Achilles tendon, and occurred within weeks to months of starting the drug. Rupture may “occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders,” the label states.
The label also advises that patients avoid concomitant use of bempedoic acid with simvastatin greater than 20 mg or pravastatin greater than 40 mg because it causes an increase in statin concentrations and may increase the risk of related myopathy.
A decision is expected shortly on a new drug application submitted by Esperion for an LDL cholesterol–lowering indication for bempedoic acid 180 mg/ezetimibe 10 mg combination tablet.
Full prescribing information is available online.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved bempedoic acid (Nexletol) for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL cholesterol lowering.
The oral adenosine triphosphate–citrate lyase (ACL) inhibitor is indicated as an adjunct to diet and maximally tolerated statin therapy in these patients, and approved at the 180 mg once daily dose, the agency announced today.
The safety and efficacy of bempedoic acid were demonstrated over 52 weeks in two multicenter randomized, clinical trials involving 3,009 adults with HeFH or established ASCVD on maximally tolerated statin therapy.
The difference between bempedoic acid and placebo for the primary outcome of change in LDL cholesterol from baseline to week 12 was –18% in the first trial, CLEAR Harmony (95% confidence interval, –20% to –16%; P less than .001), and –17% in the second trial, CLEAR Wisdom (95% CI, –21% to –14%; P less than .001).
The label notes that the effect on cardiovascular morbidity and mortality has not been determined. The label also includes warnings stating that bempedoic acid may increase blood uric acid levels and is associated with an increased risk of tendon rupture or injury.
In clinical trials, 26% of bempedoic acid–treated patients with normal baseline uric acid values versus 9.5% of placebo-treated patients experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction versus 1.1% with placebo, according to the label. Gout was reported in 1.5% of patients treated with bempedoic acid and 0.4% of those treated with placebo.
Also in clinical trials, the risk of tendon rupture was 0.5% with bempedoic acid and 0% with placebo. Tendon rupture involved the rotator cuff, biceps tendon, or Achilles tendon, and occurred within weeks to months of starting the drug. Rupture may “occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders,” the label states.
The label also advises that patients avoid concomitant use of bempedoic acid with simvastatin greater than 20 mg or pravastatin greater than 40 mg because it causes an increase in statin concentrations and may increase the risk of related myopathy.
A decision is expected shortly on a new drug application submitted by Esperion for an LDL cholesterol–lowering indication for bempedoic acid 180 mg/ezetimibe 10 mg combination tablet.
Full prescribing information is available online.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved bempedoic acid (Nexletol) for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional LDL cholesterol lowering.
The oral adenosine triphosphate–citrate lyase (ACL) inhibitor is indicated as an adjunct to diet and maximally tolerated statin therapy in these patients, and approved at the 180 mg once daily dose, the agency announced today.
The safety and efficacy of bempedoic acid were demonstrated over 52 weeks in two multicenter randomized, clinical trials involving 3,009 adults with HeFH or established ASCVD on maximally tolerated statin therapy.
The difference between bempedoic acid and placebo for the primary outcome of change in LDL cholesterol from baseline to week 12 was –18% in the first trial, CLEAR Harmony (95% confidence interval, –20% to –16%; P less than .001), and –17% in the second trial, CLEAR Wisdom (95% CI, –21% to –14%; P less than .001).
The label notes that the effect on cardiovascular morbidity and mortality has not been determined. The label also includes warnings stating that bempedoic acid may increase blood uric acid levels and is associated with an increased risk of tendon rupture or injury.
In clinical trials, 26% of bempedoic acid–treated patients with normal baseline uric acid values versus 9.5% of placebo-treated patients experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction versus 1.1% with placebo, according to the label. Gout was reported in 1.5% of patients treated with bempedoic acid and 0.4% of those treated with placebo.
Also in clinical trials, the risk of tendon rupture was 0.5% with bempedoic acid and 0% with placebo. Tendon rupture involved the rotator cuff, biceps tendon, or Achilles tendon, and occurred within weeks to months of starting the drug. Rupture may “occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders,” the label states.
The label also advises that patients avoid concomitant use of bempedoic acid with simvastatin greater than 20 mg or pravastatin greater than 40 mg because it causes an increase in statin concentrations and may increase the risk of related myopathy.
A decision is expected shortly on a new drug application submitted by Esperion for an LDL cholesterol–lowering indication for bempedoic acid 180 mg/ezetimibe 10 mg combination tablet.
Full prescribing information is available online.
This article first appeared on Medscape.com.
Prescription osteoarthritis relief gets OTC approval
The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.
The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.
The Food and Drug Administration has approved formerly prescription-only Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription use via a process known as a prescription to over-the-counter (Rx-to-OTC) switch, according to a news release from the agency.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
This switch to nonprescription status is usually initiated by the manufacturer, who must provide data that demonstrates the drug in question is both safe and effective as self-medication in accordance with the proposed labeling and that consumers can use it safely and effectively without the supervision of a health care professional.
This particular therapy is a topical NSAID gel and was first approved by the FDA in 2007 with the indication for relief of osteoarthritis pain. It can take 7 days to have an effect, but if patients find it takes longer than that or they need to use it for more than 21 days, they should seek medical attention. The gel can cause severe allergic reactions, especially in people allergic to aspirin; patients who experience such reactions are advised to stop use and seek immediate medical care. Other concerns include potential for liver damage with extended use; the possibility of severe stomach bleeds; and risk of heart attack, heart failure, and stroke.
The gel will no longer be available in prescription form.
Full prescribing information can be found on the FDA website, as can the full news release regarding this approval.
Lorcaserin withdrawn from U.S. market due to cancer risk
The Food and Drug Administration asked Eisai to voluntary withdraw the weight-loss drug lorcaserin (Belviq and Belviq XR) on Feb. 13 after a post-marketing trial with more than 12,000 subjects revealed an increased occurrence of cancer.
In a Drug Safety Communication, the agency said “health care professionals should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. Discuss alternative weight-loss medicines or strategies with your patients.”
Eisai is complying with the withdrawal request.
The decision is based on the agency’s review of the 5-year trial, which was designed to evaluate cardiac risk with the drug and ended in June 2018. In total, 7.7% of patients randomized to 10 mg lorcaserin twice daily were diagnosed with 520 primary cancers, compared with 7.1% of placebo subjects diagnosed with 470 cancers, over a median follow-up of 3 years and 3 months. There was one additional cancer observed for every 470 patients treated for 1 year.
“There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin,” FDA said. Pancreatic, colorectal, and lung cancers were among those diagnosed.
In short, “we believe that the risks of lorcaserin outweigh its benefits based on our completed review of” the data, the agency said. The FDA is not recommending special cancer screenings for patients who have taken lorcaserin.
The action follows an FDA alert in January about a possible elevated cancer risk based on its preliminary analysis of the study.
Patients were also advised Feb. 13 to stop taking the drug and talk to their providers about alternative weight-loss medications and weight-management programs.
They were also told to dispose of the pills at a drug take-back location if available, but if not, to mix them with an “unappealing substance” such as dirt, cat litter, or used coffee grounds; seal them in plastic bag; and put them in the trash.
The Food and Drug Administration asked Eisai to voluntary withdraw the weight-loss drug lorcaserin (Belviq and Belviq XR) on Feb. 13 after a post-marketing trial with more than 12,000 subjects revealed an increased occurrence of cancer.
In a Drug Safety Communication, the agency said “health care professionals should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. Discuss alternative weight-loss medicines or strategies with your patients.”
Eisai is complying with the withdrawal request.
The decision is based on the agency’s review of the 5-year trial, which was designed to evaluate cardiac risk with the drug and ended in June 2018. In total, 7.7% of patients randomized to 10 mg lorcaserin twice daily were diagnosed with 520 primary cancers, compared with 7.1% of placebo subjects diagnosed with 470 cancers, over a median follow-up of 3 years and 3 months. There was one additional cancer observed for every 470 patients treated for 1 year.
“There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin,” FDA said. Pancreatic, colorectal, and lung cancers were among those diagnosed.
In short, “we believe that the risks of lorcaserin outweigh its benefits based on our completed review of” the data, the agency said. The FDA is not recommending special cancer screenings for patients who have taken lorcaserin.
The action follows an FDA alert in January about a possible elevated cancer risk based on its preliminary analysis of the study.
Patients were also advised Feb. 13 to stop taking the drug and talk to their providers about alternative weight-loss medications and weight-management programs.
They were also told to dispose of the pills at a drug take-back location if available, but if not, to mix them with an “unappealing substance” such as dirt, cat litter, or used coffee grounds; seal them in plastic bag; and put them in the trash.
The Food and Drug Administration asked Eisai to voluntary withdraw the weight-loss drug lorcaserin (Belviq and Belviq XR) on Feb. 13 after a post-marketing trial with more than 12,000 subjects revealed an increased occurrence of cancer.
In a Drug Safety Communication, the agency said “health care professionals should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. Discuss alternative weight-loss medicines or strategies with your patients.”
Eisai is complying with the withdrawal request.
The decision is based on the agency’s review of the 5-year trial, which was designed to evaluate cardiac risk with the drug and ended in June 2018. In total, 7.7% of patients randomized to 10 mg lorcaserin twice daily were diagnosed with 520 primary cancers, compared with 7.1% of placebo subjects diagnosed with 470 cancers, over a median follow-up of 3 years and 3 months. There was one additional cancer observed for every 470 patients treated for 1 year.
“There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin,” FDA said. Pancreatic, colorectal, and lung cancers were among those diagnosed.
In short, “we believe that the risks of lorcaserin outweigh its benefits based on our completed review of” the data, the agency said. The FDA is not recommending special cancer screenings for patients who have taken lorcaserin.
The action follows an FDA alert in January about a possible elevated cancer risk based on its preliminary analysis of the study.
Patients were also advised Feb. 13 to stop taking the drug and talk to their providers about alternative weight-loss medications and weight-management programs.
They were also told to dispose of the pills at a drug take-back location if available, but if not, to mix them with an “unappealing substance” such as dirt, cat litter, or used coffee grounds; seal them in plastic bag; and put them in the trash.
Two new Novel Coronavirus cases confirmed among quarantined U.S. patients
The Centers for Disease Control and Prevention announced two new patients now have the 2019 Novel Coronavirus (2019-nCoV), bringing the case total in the United States to 15.
The 14th case was discovered in California among a group of people under federal quarantine after returning from the Hubei Province in China. That patient was on a U.S. State Department–chartered flight that arrived in the United States on Feb. 7.
The 15th case was discovered in Texas among a group of people who also are under federal quarantine. That patient arrived on a State Department–chartered flight that arrived on Feb. 7. It is the first person in Texas that has tested positive for 2019-nCoV.
CDC said in a statement announcing the Texas case that there “will likely be additional cases in the coming days and weeks, including among other people recently returned from Wuhan.” Officials noted that more than 600 people who have returned as part of State Department–chartered flights are currently under that 14-day quarantine.
The agency is preparing for more widespread cases of 2019-nCoV.
Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, said that containment has been the early focus for the agency.
“The goal of the measures we have taken to date are to slow the introduction and impact of this disease in the United States, but at some point, we are likely to see community spread in the U.S.,” Dr. Messonnier said during a Feb. 12 teleconference with reporters. She added that the federal response will change over time as the virus spreads.
Dr. Messonnier noted that public health officials are planning for the increased demands that a wider outbreak of 2019-nCov would place on the health care delivery system, including ensuring an adequate supply of medical equipment.
The Centers for Disease Control and Prevention announced two new patients now have the 2019 Novel Coronavirus (2019-nCoV), bringing the case total in the United States to 15.
The 14th case was discovered in California among a group of people under federal quarantine after returning from the Hubei Province in China. That patient was on a U.S. State Department–chartered flight that arrived in the United States on Feb. 7.
The 15th case was discovered in Texas among a group of people who also are under federal quarantine. That patient arrived on a State Department–chartered flight that arrived on Feb. 7. It is the first person in Texas that has tested positive for 2019-nCoV.
CDC said in a statement announcing the Texas case that there “will likely be additional cases in the coming days and weeks, including among other people recently returned from Wuhan.” Officials noted that more than 600 people who have returned as part of State Department–chartered flights are currently under that 14-day quarantine.
The agency is preparing for more widespread cases of 2019-nCoV.
Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, said that containment has been the early focus for the agency.
“The goal of the measures we have taken to date are to slow the introduction and impact of this disease in the United States, but at some point, we are likely to see community spread in the U.S.,” Dr. Messonnier said during a Feb. 12 teleconference with reporters. She added that the federal response will change over time as the virus spreads.
Dr. Messonnier noted that public health officials are planning for the increased demands that a wider outbreak of 2019-nCov would place on the health care delivery system, including ensuring an adequate supply of medical equipment.
The Centers for Disease Control and Prevention announced two new patients now have the 2019 Novel Coronavirus (2019-nCoV), bringing the case total in the United States to 15.
The 14th case was discovered in California among a group of people under federal quarantine after returning from the Hubei Province in China. That patient was on a U.S. State Department–chartered flight that arrived in the United States on Feb. 7.
The 15th case was discovered in Texas among a group of people who also are under federal quarantine. That patient arrived on a State Department–chartered flight that arrived on Feb. 7. It is the first person in Texas that has tested positive for 2019-nCoV.
CDC said in a statement announcing the Texas case that there “will likely be additional cases in the coming days and weeks, including among other people recently returned from Wuhan.” Officials noted that more than 600 people who have returned as part of State Department–chartered flights are currently under that 14-day quarantine.
The agency is preparing for more widespread cases of 2019-nCoV.
Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, said that containment has been the early focus for the agency.
“The goal of the measures we have taken to date are to slow the introduction and impact of this disease in the United States, but at some point, we are likely to see community spread in the U.S.,” Dr. Messonnier said during a Feb. 12 teleconference with reporters. She added that the federal response will change over time as the virus spreads.
Dr. Messonnier noted that public health officials are planning for the increased demands that a wider outbreak of 2019-nCov would place on the health care delivery system, including ensuring an adequate supply of medical equipment.
FDA issues MiniMed600 insulin pump recall
according to a Food and Drug Administration MedWatch release.
A class I recall such as this indicates that there is reasonable probability that using a defective pump will cause serious adverse health consequences or death, the agency said in the recall notice. It said the company has received more than 26,000 complaints regarding this problem and is aware of 2,175 injuries and 1 death so far. In all, 322,005 devices have been recalled.
If the pumps in question – Model 630G (distributed September 2016 to October 2019) and 670G (June 2017 to August 2019) – have broken or missing retainer rings, the insulin cartridge can end up loose in the reservoir compartment, which can lead to incorrect dosing and therefore potentially to hyperglycemia or hypoglycemia, according to the statement.
Model 630G was approved by the FDA in August 2016, and the 670G in September that same year.
On Nov. 21, 2019, Medtronic advised patients with type 1 diabetes who use the pumps to:
- Examine the retainer ring to see if it is loose, broken, or missing.
- Stop using the pump if the reservoir does not lock correctly or if the retainer ring is loose, damaged, or missing. Patients should contact Medtronic for a replacement pump and follow their doctor’s recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- Check pump and retainer ring if the pump is dropped by accident, and stop use if it is damaged.
- Check the pump and retainer ring every set change to verify the reservoir is locked correctly.
More information regarding this recall, including how to contact Medtronic Technical Support, can be found on the FDA website.
according to a Food and Drug Administration MedWatch release.
A class I recall such as this indicates that there is reasonable probability that using a defective pump will cause serious adverse health consequences or death, the agency said in the recall notice. It said the company has received more than 26,000 complaints regarding this problem and is aware of 2,175 injuries and 1 death so far. In all, 322,005 devices have been recalled.
If the pumps in question – Model 630G (distributed September 2016 to October 2019) and 670G (June 2017 to August 2019) – have broken or missing retainer rings, the insulin cartridge can end up loose in the reservoir compartment, which can lead to incorrect dosing and therefore potentially to hyperglycemia or hypoglycemia, according to the statement.
Model 630G was approved by the FDA in August 2016, and the 670G in September that same year.
On Nov. 21, 2019, Medtronic advised patients with type 1 diabetes who use the pumps to:
- Examine the retainer ring to see if it is loose, broken, or missing.
- Stop using the pump if the reservoir does not lock correctly or if the retainer ring is loose, damaged, or missing. Patients should contact Medtronic for a replacement pump and follow their doctor’s recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- Check pump and retainer ring if the pump is dropped by accident, and stop use if it is damaged.
- Check the pump and retainer ring every set change to verify the reservoir is locked correctly.
More information regarding this recall, including how to contact Medtronic Technical Support, can be found on the FDA website.
according to a Food and Drug Administration MedWatch release.
A class I recall such as this indicates that there is reasonable probability that using a defective pump will cause serious adverse health consequences or death, the agency said in the recall notice. It said the company has received more than 26,000 complaints regarding this problem and is aware of 2,175 injuries and 1 death so far. In all, 322,005 devices have been recalled.
If the pumps in question – Model 630G (distributed September 2016 to October 2019) and 670G (June 2017 to August 2019) – have broken or missing retainer rings, the insulin cartridge can end up loose in the reservoir compartment, which can lead to incorrect dosing and therefore potentially to hyperglycemia or hypoglycemia, according to the statement.
Model 630G was approved by the FDA in August 2016, and the 670G in September that same year.
On Nov. 21, 2019, Medtronic advised patients with type 1 diabetes who use the pumps to:
- Examine the retainer ring to see if it is loose, broken, or missing.
- Stop using the pump if the reservoir does not lock correctly or if the retainer ring is loose, damaged, or missing. Patients should contact Medtronic for a replacement pump and follow their doctor’s recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- Check pump and retainer ring if the pump is dropped by accident, and stop use if it is damaged.
- Check the pump and retainer ring every set change to verify the reservoir is locked correctly.
More information regarding this recall, including how to contact Medtronic Technical Support, can be found on the FDA website.
CDC confirms 13th case of coronavirus in U.S.
The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.
The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.
The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.
“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.
Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.
“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.
She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.
With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.
In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.
Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.
She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.
“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.
Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.
The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.
The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.
The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.
“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.
Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.
“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.
She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.
With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.
In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.
Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.
She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.
“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.
Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.
The Centers for Disease Control and Prevention announced the number of confirmed cases of the 2019 Novel Coronavirus (2019-nCoV) in the United States has reached 13.
The latest case, announced Feb. 11, 2020, by the CDC, was in a person in California who was previously under federal quarantine because the patient had traveled to Wuhan, China.
The CDC is currently looking into who the patient may have come in contact with to understand the potential for further spread of the coronavirus.
“The contact investigation is ongoing,” CDC principal deputy director Anne Schuchat, MD, said during a Feb. 11 press conference to provide an update on coronavirus containment activities being taken by the CDC.
Dr. Schuchat also addressed issues related to the laboratory test, as the patient in California was initially thought to be negative for the coronavirus.
“With other cases around the country that we are evaluating, we have been doing serial tests to understand whether they are still infectious” and to gather other information about how results change over time, Dr. Schuchat said.
She noted that the CDC does not “have as much information as we would like on the severity of the virus,” noting that there are many cases in China with severe reactions, while the 13 cases in the United States represent a much more mild reaction to the virus so far.
With the latest case in California, she noted that there was “probably a mix-up and the original test wasn’t negative,” although she did not elaborate on what the nature of the mix-up was, stating that was all the information that she had.
In general, Dr. Schuchat touted the actions taken by the CDC and the federal government focused primarily on containing the spread of the virus in the United States, including the implementation of travel advisories, quarantining passengers returning from China, as well as the new test kits that are being distributed by the agency across the nation and around the world. She also mentioned CDC staff are being deployed around the world to monitor the spreading of the disease and highlighted the outreach efforts to keep the public informed.
Dr. Schuchat highlighted the fact that, of the 13 cases in the United States, 11 were with patients that were in Wuhan, and only 2 were because of close contact with a patient, something that she attributed to the actions being taken.
She also noted that cases in the United States have not been as severe as they have been in China, where deaths have been attributed to the coronavirus outbreak. She added that there have been only two deaths outside of mainland China attributed to the coronavirus.
“Some of the steps the CDC has taken have really put us in better shape should widespread transmission occur in the United States,” she said.
Dr. Schuchat also highlighted that the first charter flight of people quarantined after returning from Wuhan have reached the 14-day milestone and should be on their way home beginning today.
FDA: Cell phones still look safe
according to a review by the Food and Drug Administration.
The FDA reviewed the published literature from 2008 to 2018 and concluded that the data don’t support any quantifiable adverse health risks from RFR. However, the evidence is not without limitations.
The FDA’s evaluation included evidence from in vivo animal studies from Jan. 1, 2008, to Aug. 1, 2018, and epidemiologic studies in humans from Jan. 1, 2008, to May 8, 2018. Both kinds of evidence had limitations, but neither produced strong indications of any causal risks from cell phone use.
The FDA noted that in vivo animal studies are limited by variability of methods and RFR exposure, which make comparisons of results difficult. These studies are also impacted by the indirect effects of temperature increases (the only currently established biological effect of RFR) and stress experienced by the animals, which make teasing out the direct effects of RFR difficult.
The FDA noted that strong epidemiologic studies can provide more relevant and accurate information than in vivo studies, but epidemiologic studies are not without limitations. For example, most have participants track and self-report their cell phone use. There’s also no way to directly track certain factors of RFR exposure, such as frequency, duration, or intensity.
Even with those caveats in mind, the FDA wrote that, “based on the studies that are described in detail in this report, there is insufficient evidence to support a causal association between RFR exposure and tumorigenesis. There is a lack of clear dose-response relationship, a lack of consistent findings or specificity, and a lack of biological mechanistic plausibility.”
The full review is available on the FDA website.
according to a review by the Food and Drug Administration.
The FDA reviewed the published literature from 2008 to 2018 and concluded that the data don’t support any quantifiable adverse health risks from RFR. However, the evidence is not without limitations.
The FDA’s evaluation included evidence from in vivo animal studies from Jan. 1, 2008, to Aug. 1, 2018, and epidemiologic studies in humans from Jan. 1, 2008, to May 8, 2018. Both kinds of evidence had limitations, but neither produced strong indications of any causal risks from cell phone use.
The FDA noted that in vivo animal studies are limited by variability of methods and RFR exposure, which make comparisons of results difficult. These studies are also impacted by the indirect effects of temperature increases (the only currently established biological effect of RFR) and stress experienced by the animals, which make teasing out the direct effects of RFR difficult.
The FDA noted that strong epidemiologic studies can provide more relevant and accurate information than in vivo studies, but epidemiologic studies are not without limitations. For example, most have participants track and self-report their cell phone use. There’s also no way to directly track certain factors of RFR exposure, such as frequency, duration, or intensity.
Even with those caveats in mind, the FDA wrote that, “based on the studies that are described in detail in this report, there is insufficient evidence to support a causal association between RFR exposure and tumorigenesis. There is a lack of clear dose-response relationship, a lack of consistent findings or specificity, and a lack of biological mechanistic plausibility.”
The full review is available on the FDA website.
according to a review by the Food and Drug Administration.
The FDA reviewed the published literature from 2008 to 2018 and concluded that the data don’t support any quantifiable adverse health risks from RFR. However, the evidence is not without limitations.
The FDA’s evaluation included evidence from in vivo animal studies from Jan. 1, 2008, to Aug. 1, 2018, and epidemiologic studies in humans from Jan. 1, 2008, to May 8, 2018. Both kinds of evidence had limitations, but neither produced strong indications of any causal risks from cell phone use.
The FDA noted that in vivo animal studies are limited by variability of methods and RFR exposure, which make comparisons of results difficult. These studies are also impacted by the indirect effects of temperature increases (the only currently established biological effect of RFR) and stress experienced by the animals, which make teasing out the direct effects of RFR difficult.
The FDA noted that strong epidemiologic studies can provide more relevant and accurate information than in vivo studies, but epidemiologic studies are not without limitations. For example, most have participants track and self-report their cell phone use. There’s also no way to directly track certain factors of RFR exposure, such as frequency, duration, or intensity.
Even with those caveats in mind, the FDA wrote that, “based on the studies that are described in detail in this report, there is insufficient evidence to support a causal association between RFR exposure and tumorigenesis. There is a lack of clear dose-response relationship, a lack of consistent findings or specificity, and a lack of biological mechanistic plausibility.”
The full review is available on the FDA website.
FDA not recommending recalls of diabetes drug metformin
The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.
The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.
That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.
This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”
“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.
More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.
“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”
The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.
For more information about NDMA, visit the FDA’s nitrosamines webpage.
The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
This article first appeared on Medscape.com.
The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.
The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.
That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.
This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”
“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.
More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.
“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”
The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.
For more information about NDMA, visit the FDA’s nitrosamines webpage.
The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
This article first appeared on Medscape.com.
The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.
The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.
That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.
This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”
“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.
More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.
“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”
The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.
For more information about NDMA, visit the FDA’s nitrosamines webpage.
The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
This article first appeared on Medscape.com.