en FDA Drug Safety Podcasts false U.S. Food and Drug Administration, Center for Drug Evaluation and Research https://www.fda.gov/files/DrugSafetyPodcast-iTunesAlbumGraphic_3000x3000-min.pnghttps://www.fda.govFDA Drug Safety Podcasts U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchCDERPodcasts@fda.hhs.gov https://www.fda.gov/drugsafetypodcasts FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins Thu, 22 Jul 2021 15:44:31 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210722-154431 FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy false 3:00 FDA warns that vapors from alcohol-based hand sanitizers can have side effects Mon, 21 Jun 2021 06:02:41 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210621-060241 FDA warns that vapors from alcohol-based hand sanitizers can have side effects http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-vapors-alcohol-based-hand-sanitizers-can-have-side-effects false Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis Thu, 03 Jun 2021 08:40:04 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210603-084004 Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis http://www.fda.gov/drugs/fda-drug-safety-podcasts/due-risk-serious-liver-injury-fda-restricts-use-obeticholic-acid-ocaliva-primary-biliary-cholangitis false 3:00 Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease Fri, 02 Apr 2021 11:01:22 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210402-110122 Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease http://www.fda.gov/drugs/fda-drug-safety-podcasts/studies-show-increased-risk-heart-rhythm-problems-seizure-and-mental-health-medicine-lamotrigine false 3:00 FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm Mon, 29 Mar 2021 09:48:47 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210329-094847 FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-abuse-and-misuse-otc-nasal-decongestant-propylhexedrine-can-lead-serious-harm ]]> false 3:00 Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) Mon, 08 Feb 2021 09:27:17 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210208-092717 Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) http://www.fda.gov/drugs/fda-drug-safety-podcasts/initial-safety-trial-results-find-increased-risk-serious-heart-related-problems-and-cancer-arthritis false 3:00 FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid Thu, 22 Oct 2020 14:11:29 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20201022-141129 FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic false 3:00 FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl) Tue, 29 Sep 2020 09:27:35 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200929-092735 FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-serious-problems-high-doses-allergy-medicine-diphenhydramine-benadryl false 3:00 FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class Tue, 29 Sep 2020 09:15:36 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200929-091536 FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class false 3:00 FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) Tue, 01 Sep 2020 16:17:50 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200901-161750 FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin false 3:00 FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder Wed, 29 Jul 2020 10:41:09 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200729-104109 FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain false 3:00 FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems Fri, 24 Apr 2020 16:47:57 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200424-164757 FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or false 3:32 FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market Wed, 19 Feb 2020 12:31:30 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200219-123130 FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market false 3:00 FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems Mon, 10 Feb 2020 09:10:49 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200210-091049 FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-strengthens-warning-untreated-constipation-caused-schizophrenia-medicine-clozapine-clozaril-can false 3:00 Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin) Thu, 23 Jan 2020 12:19:33 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200123-121933 Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin) http://www.fda.gov/drugs/fda-drug-safety-podcasts/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr false 2:00 FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) Thu, 02 Jan 2020 12:20:33 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20200102-122033 FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin false 3:00 FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease Wed, 11 Sep 2019 12:15:20 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190911-121520 FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and false 3:00 FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) Mon, 05 Aug 2019 11:01:42 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190805-110142 FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and false 3:00 FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines Fri, 10 May 2019 10:56:59 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190510-105659 FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia false FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering Wed, 17 Apr 2019 08:29:32 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190417-082932 FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes false 3:00 Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate Tue, 05 Mar 2019 13:47:02 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190305-134702 Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate http://www.fda.gov/drugs/fda-drug-safety-podcasts/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr false 3:00 FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) Tue, 05 Mar 2019 13:35:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190305-133500 FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-symptoms-serious-condition-affecting-blood-cells-are-not-being-recognized-leukemia false 3:00 FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) Tue, 05 Mar 2019 13:16:51 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190305-131651 FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug false 3:00 FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) Tue, 05 Mar 2019 12:54:13 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190305-125413 FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat false FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes Wed, 05 Sep 2018 12:01:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180905-120100 FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2 false FDA Drug Safety Podcast: FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant Mon, 06 Aug 2018 15:15:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180806-151500 FDA Drug Safety Podcast: FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-increased-risk-cancer-relapse-long-term-use-azithromycin false FDA Drug Safety Podcast: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes Thu, 12 Jul 2018 09:32:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180712-093200 FDA Drug Safety Podcast: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-and false FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics Fri, 01 Jun 2018 12:59:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180601-125900 FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-risk-serious-and-potentially-fatal-blood-disorder-prompts-fda-action-oral false FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) Thu, 24 May 2018 08:35:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180524-083500 FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-evaluate-potential-risk-neural-tube-birth-defects-hiv-medicine false FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) Mon, 30 Apr 2018 14:15:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180430-141500 FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-serious-immune-system-reaction-seizure-and-mental-health-medicine false FDA Drug Safety Podcast: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease Tue, 27 Feb 2018 09:35:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180227-093500 FDA Drug Safety Podcast: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-finds-additional-data-supports-potential-increased-long-term false FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease Wed, 07 Feb 2018 14:44:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180207-144400 FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-adds-boxed-warning-highlight-correct-dosing-ocaliva-obeticholic-acid false FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use Tue, 06 Feb 2018 15:08:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180206-150800 FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-limits-packaging-anti-diarrhea-medicine-loperamide-imodium-encourage false FDA Drug Safety Podcast: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older Tue, 16 Jan 2018 11:11:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180116-111100 FDA Drug Safety Podcast: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-requires-labeling-changes-prescription-opioid-cough-and-cold-medicines false FDA Drug Safety Podcast: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS) Tue, 02 Jan 2018 10:26:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180102-102600 FDA Drug Safety Podcast: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes-long false FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings Thu, 21 Dec 2017 10:35:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20171221-103500 FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-gadolinium-based-contrast-agents-gbcas-are-retained-body-requires false FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric) Mon, 20 Nov 2017 14:19:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20171120-141900 FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-evaluate-increased-risk-heart-related-death-and-death-all-causes-gout false FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease Wed, 04 Oct 2017 16:50:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20171004-165000 FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare-chronic false FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks Mon, 02 Oct 2017 11:48:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20171002-114800 FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-urges-caution-about-withholding-opioid-addiction-medications-patients false FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs Thu, 14 Sep 2017 11:18:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170914-111800 FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-recommends-separating-dosing-potassium-lowering-drug-sodium-polystyrene false FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue Fri, 26 May 2017 08:54:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170526-085400 FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-identifies-no-harmful-effects-date-brain-retention-gadolinium-based false FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) Thu, 25 May 2017 10:48:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170525-104800 FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-confirms-increased-risk-leg-and-foot-amputations-diabetes-medicine false FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children Mon, 01 May 2017 13:07:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170501-130700 FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-approves-label-changes-use-general-anesthetic-and-sedation-drugs-young false 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 Thu, 27 Apr 2017 08:55:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170427-085500 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 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-restricts-use-prescription-codeine-pain-and-cough-medicines-and-tramadol false FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder Wed, 22 Mar 2017 08:19:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170322-081900 FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-increased-risk-serious-pancreatitis-irritable-bowel-drug false FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate Wed, 08 Feb 2017 14:57:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170208-145700 FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-rare-serious-allergic-reactions-skin-antiseptic false FDA Drug Safety Podcast: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women Wed, 28 Dec 2016 15:20:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20161228-152000 FDA Drug Safety Podcast: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-results-new-warnings-about-using-general-anesthetics-and-sedation false FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer Wed, 28 Dec 2016 15:20:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20161228-152000 FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-updated-fda-review-concludes-use-pioglitazone-may-be-linked-increased-risk false FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings Wed, 28 Dec 2016 15:20:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20161228-152000 FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-revises-description-mental-health-side-effects-stop-smoking-medicines false FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C Fri, 07 Oct 2016 13:33:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20161007-133300 FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-risk-hepatitis-b-reactivating-some-patients-treated-direct false FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning Wed, 07 Sep 2016 08:21:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160907-082100 FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-risks-and-death-when-combining-opioid-pain-or-cough false FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects Tue, 02 Aug 2016 11:19:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160802-111900 FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-updates-warnings-oral-and-injectable-fluoroquinolone-antibiotics-due false Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch Tue, 21 Jun 2016 09:22:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160621-092200 Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch http://www.fda.gov/drugs/fda-drug-safety-podcasts/update-fda-evaluating-risk-burns-and-scars-zecuity-sumatriptan-migraine-patch false FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) Tue, 21 Jun 2016 09:22:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160621-092200 FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-strengthens-kidney-warnings-diabetes-medicines-canagliflozin-invokana-invokamet-and false FDA Drug Safety Podcast: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse Thu, 16 Jun 2016 09:01:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160616-090100 FDA Drug Safety Podcast: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-heart-problems-high-doses-antidiarrheal-medicine false FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch Wed, 08 Jun 2016 10:05:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160608-100500 FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-evaluating-risk-burns-and-scars-zecuity-sumatriptan-migraine-patch false FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin Wed, 08 Jun 2016 10:05:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160608-100500 FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-bleeding-risk-over-counter-antacid-products false 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 Fri, 03 Jun 2016 06:02:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160603-060200 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 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-prescribing-nizoral-ketoconazole-oral-tablets-unapproved-uses false 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 Thu, 26 May 2016 08:46:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160526-084600 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 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-interim-clinical-trial-results-find-increased-risk-leg-and-foot-amputations false FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together Wed, 25 May 2016 13:42:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160525-134200 FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-advises-restricting-fluoroquinolone-antibiotic-use-certain-uncomplicated false FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) Tue, 17 May 2016 14:58:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160517-145800 FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-rare-serious-skin-reactions-mental-health-drug-olanzapine false FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada) Fri, 06 May 2016 12:32:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160506-123200 FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-new-impulse-control-problems-associated-mental-health-drug false FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) Fri, 06 May 2016 08:26:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160506-082600 FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-approves-brand-name-change-antidepressant-drug-brintellix-vortioxetine false FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy Tue, 03 May 2016 10:24:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160503-102400 FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-study-examining-use-oral-fluconazole-diflucan-pregnancy false FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure Wed, 27 Apr 2016 15:09:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160427-150900 FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-announced-safety-review-has-found-type-2-diabetes-medicines-containing-saxagliptin-and false FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function Thu, 14 Apr 2016 12:07:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160414-120700 FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-revises-warnings-regarding-use-diabetes-medicine-metformin-certain false FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes Thu, 31 Mar 2016 08:49:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160331-084900 FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-several-safety-issues-opioid-pain-medicines-requires-label false FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved Tue, 12 Jan 2016 08:23:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20160112-082300 FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-cautions-about-dosing-errors-when-switching-between-different-oral false