en FDA Drug Safety Podcast Wed, 27 Jan 2021 15:18:41 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research false U.S. Food and Drug Administration, Center for Drug Evaluation and Research http://www.fda.gov/files/DrugSafetyPodcast-iTunesAlbumGraphic_3000x3000-min.pnghttp://www.fda.govFDA Drug Safety Podcast U.S. Food and Drug Administration, Center for Drug Evaluation and Research http://www.fda.gov/drugsafetypodcasts FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C Wed, 27 Jan 2021 15:18:41 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/371291 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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, 27 Jan 2021 15:16:30 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/372265 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/406503 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/406154 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class Tue, 29 Sep 2020 09:23:32 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/406149 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) Tue, 08 Sep 2020 13:52:13 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/405833 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder Wed, 02 Sep 2020 11:54:54 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/405357 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/404055 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin Thu, 27 Feb 2020 08:48:36 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/370292 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/401150 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/400602 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/399586 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 node/398466 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Fri, 20 Dec 2019 21:15:22 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/392610 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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) Fri, 20 Dec 2019 21:05:52 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/390297 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines Fri, 20 Dec 2019 20:44:51 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/388929 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering Fri, 20 Dec 2019 20:35:24 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/387933 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Fri, 20 Dec 2019 20:21:49 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/387005 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) Fri, 20 Dec 2019 20:21:48 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/387004 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) Fri, 20 Dec 2019 20:21:46 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/387002 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 U.S. Food and Drug Administration, Center for Drug Evaluation and Research