FDA Drug Safety Podcast FDA Drug Safety Podcasts http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/default.htm en-us U.S. Food and Drug Administration, Center for Drug Evaluation and Research The FDA Drug Safety Podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. Center for Drug Evaluation and Research druginfo@fda.hhs.gov (CDER Division of Drug Information) no Fri, 02 Jun 2017 16:20 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue On May 22, 2017, FDA announced that to date a review has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Thu, 25 May 2017 12:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm560700.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm560700.htm unrelated, harmful, effects, brain retention, Drug Safety FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) On May 16, 2017, based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. Thu, 25 May 2017 12:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm560492.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm560492.htm patients, risk, leg, foot, amputations, Drug Safety FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children On April 27, 2017 FDA notified the public that we have approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. Mon, 01 May 2017 13:15 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm556028.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm556028.htm label changes, negatively affect brain development, loss of nerve cells, young children, Drug Safety FDA Drug Safety Podcast: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women On April 20, 2017, FDA announced it is restricting the use of codeine and tramadol medicines in children. Wed, 26 Apr 2017 14:15 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm555252.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm555252.htm restrictions, prescription, codeine, tramadol medicines, children, Drug Safety FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder On March 15, 2017, FDA announced it is warning that Viberzi (active ingredient eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. Wed, 22 Mar 2017 08:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm547907.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm547907.htm warning, rare, serious, allergic reactions, Drug Safety FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate On February 2, 2017, the FDA announced it is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Wed, 08 Feb 2017 12:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm540654.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm540654.htm warning, rare, serious, allergic reactions, Drug Safety FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings On December 16, 2016, the FDA announced that based on our review of a large clinical trial that we required the drug companies to conduct, we have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (active ingredient varenicline) and Zyban (active ingredient bupropion) is lower than previously suspected. Wed, 28 Dec 2016 12:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm534857.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm534857.htm serious side effects, mood, behavior, thinking, Drug Safety FDA Drug Safety Podcast: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women On December 14, 2016, FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. Wed, 28 Dec 2016 11:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm534870.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm534870.htm warning, young children, negative effects, behavior or learning, Drug Safety FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer On December 12, 2016, FDA announced as a result of an updated review, that it has concluded that use of the type 2 diabetes medicine pioglitazone (brand names Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. Wed, 28 Dec 2016 11:00 EDT https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm534865.htm https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm534865.htm risk, bladder cancer, Drug Safety FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C On October 4, 2016, FDA announced it is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. Fri, 07 Oct 2016 13:35 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm524589.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm524589.htm warning, hepatitis B virus, serious liver problems or death, Drug Safety FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning On August 31, 2016, FDA announced that a review has found that the growing use of combining opioid medicines with benzodiazepines and other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Wed, 07 Sep 2016 08:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm519406.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm519406.htm serious side effects, slowed or difficult breathing, deaths, Drug Safety FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects On July 26, 2016, FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). Tue, 02 Aug 2016 11:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm514482.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm514482.htm disabling side effects, cardiac, dermatologic, hypersensitivity reactions, Drug Safety FDA Drug Safety Podcast: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) On June 14, 2016, FDA strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (brand names Invokana, Invokamet) and dapagliflozin (brand names Farxiga, Xigduo XR). Tue, 21 Jun 2016 08:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm507785.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm507785.htm risk, acute kidney injury, Drug Safety FDA Drug Safety Podcast: Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch On June 10, 2016, Zecuity manufacturer, Teva Pharmaceuticals, announced it has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Tue, 21 Jun 2016 08:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm507770.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm507770.htm discontinue, sales, marketing, distribution, burns, scars, Drug Safety FDA Drug Safety Podcast: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse On June 7, 2016, FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (brand name Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. Wed, 15 Jun 2016 07:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm506835.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm506835.htm heart problems, abnormal heart rhythm, death, Drug Safety FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin On June 6, 2016, FDA warned consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Wed, 08 Jun 2016 07:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm505554.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm505554.htm risk of serious bleeding, over-the-counter, OTC, aspirin products, Drug Safety FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch On June 2, 2016, FDA announced it is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Wed, 08 Jun 2016 07:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm505621.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm505621.htm risk of serious burns, potential permanent scarring, patch, Drug Safety FDA Drug Safety Podcast: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death On May 19, 2016, FDA announced it is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Fri, 03 Jun 2016 06:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm504300.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm504300.htm liver damage, adrenal gland problems, harmful interactions, Drug Safety FDA Drug Safety Podcast: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate On May 18, 2016, FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (brand names Invokana, Invokamet). Thu, 26 May 2016 11:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503452.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503452.htm leg, foot, amputations, toes, diabetes, Drug Safety FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together On May 12, 2016 FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. Tue, 17 May 2016 15:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503021.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503021.htm tendons, muscles, joints, nerves, and central nervous system, Drug Safety FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) On May 10, 2016, the U.S. Food and Drug Administration (FDA) announced it is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. Tue, 17 May 2016 15:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm501372.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm501372.htm new warning, DRESS, Drug Safety FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) On May 2, 2016, FDA announced it has approved a brand name change for the antidepressant Brintellix (active ingredient vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (active ingredient ticagrelor). Fri, 06 May 2016 08:35 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm499576.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm499576.htm antidepressant, brand name change, Drug Safety FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy On April 26, 2016 FDA announced that it is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (brand name Diflucan) for yeast infections. Tue, 03 May 2016 10:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm498830.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm498830.htm pregnancy, miscarriage, yeast infections, Drug Safety FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function On April 8, 2016 FDA announced it is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. Thu, 14 Apr 2016 12:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm496092.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm496092.htm diabetes, medicine, kidney function, Drug Safety