enfalseU.S. Food and Drug Administration, Center for Drug Evaluation and Researchhttps://www.fda.gov/files/DrugSafetyPodcast-iTunesAlbumGraphic_3000x3000-min.pnghttps://www.fda.govU.S. Food and Drug Administration, Center for Drug Evaluation and ResearchCDERPodcasts@fda.hhs.govhttps://www.fda.gov/drugsafetypodcastsTue, 06 Feb 2024 13:22:36 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240206-132236FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-diseasefalse4:00Fri, 26 Jan 2024 09:32:03 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240126-093203Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesityhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-typefalse3:30Fri, 08 Dec 2023 09:07:15 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20231208-090715FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-rare-serious-drug-reaction-antiseizure-medicines-levetiracetam-keppra-keppra-xr-elepsia-xrfalse5:05Wed, 31 May 2023 09:57:27 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230531-095727FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditionshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditionsfalse5:30Wed, 10 May 2023 06:43:28 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230510-064328FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe usehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-usefalse7:30Fri, 16 Dec 2022 16:07:19 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221216-160719FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-investigating-risk-severe-hypocalcemia-patients-dialysis-receiving-osteoporosis-medicine-proliafalse4:00Wed, 27 Jul 2022 11:18:46 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220727-111846FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-possible-increased-risk-death-and-serious-side-effects-cancer-drug-copiktrafalseThu, 07 Jul 2022 12:35:06 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220707-123506FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concernshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-withdrew-its-approval-cancer-medicine-ukoniq-umbralisib-due-safety-concernsfalse2:00Wed, 13 Apr 2022 12:17:47 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220413-121747FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaginghttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-recommends-thyroid-monitoring-babies-and-young-children-who-receive-injections-iodine-containingfalse4:30Wed, 09 Feb 2022 14:08:04 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220209-140804FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-investigating-possible-increased-risk-death-lymphoma-medicine-ukoniq-umbralisibfalse3:30Mon, 24 Jan 2022 12:42:49 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220124-124249 FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and painhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorderfalse5:59Tue, 09 Nov 2021 09:06:01 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211109-090601FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injuryhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-getting-alcohol-based-hand-sanitizer-eyes-can-cause-serious-injuryfalse4:00Wed, 08 Sep 2021 09:03:22 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210908-090322FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditionshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-deathfalse4:00Thu, 22 Jul 2021 15:44:31 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210722-154431FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statinshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancyfalse3:00Mon, 21 Jun 2021 06:02:41 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210621-060241FDA warns that vapors from alcohol-based hand sanitizers can have side effectshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-vapors-alcohol-based-hand-sanitizers-can-have-side-effectsfalse4:29Thu, 03 Jun 2021 08:40:04 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210603-084004Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosishttp://www.fda.gov/drugs/fda-drug-safety-podcasts/due-risk-serious-liver-injury-fda-restricts-use-obeticholic-acid-ocaliva-primary-biliary-cholangitisfalse3:00Fri, 02 Apr 2021 11:01:22 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210402-110122Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseasehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/studies-show-increased-risk-heart-rhythm-problems-seizure-and-mental-health-medicine-lamotriginefalse3:00Mon, 29 Mar 2021 09:48:47 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210329-094847FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harmhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-abuse-and-misuse-otc-nasal-decongestant-propylhexedrine-can-lead-serious-harm ]]>false3:00Mon, 08 Feb 2021 09:27:17 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210208-092717Initial 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-arthritisfalse3:00Thu, 22 Oct 2020 14:11:29 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20201022-141129FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluidhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amnioticfalse3:00Tue, 29 Sep 2020 09:27:35 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200929-092735FDA 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-benadrylfalse3:00Tue, 29 Sep 2020 09:15:36 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200929-091536FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug classhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-classfalse3:00Tue, 01 Sep 2020 16:17:50 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200901-161750FDA 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-canagliflozinfalse3:00Wed, 29 Jul 2020 10:41:09 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200729-104109FDA 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-painfalse3:00Fri, 24 Apr 2020 16:47:57 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200424-164757FDA 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 problemshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-orfalse3:32Wed, 19 Feb 2020 12:31:30 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200219-123130FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the markethttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-marketfalse3:00Mon, 10 Feb 2020 09:10:49 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200210-091049FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problemshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-strengthens-warning-untreated-constipation-caused-schizophrenia-medicine-clozapine-clozaril-canfalse3:00Thu, 23 Jan 2020 12:19:33 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200123-121933Safety 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-xrfalse2:00Thu, 02 Jan 2020 12:20:33 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20200102-122033FDA 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-neurontinfalse3:00Wed, 11 Sep 2019 12:15:20 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190911-121520FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver diseasehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-andfalse3:00Mon, 05 Aug 2019 11:01:42 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190805-110142FDA 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-andfalse3:00Fri, 10 May 2019 10:56:59 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190510-105659FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicineshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomniafalseWed, 17 Apr 2019 08:29:32 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190417-082932FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized taperinghttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changesfalse3:00Tue, 05 Mar 2019 13:47:02 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190305-134702Safety 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 investigatehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xrfalse3:00Tue, 05 Mar 2019 13:35:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190305-133500FDA 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-leukemiafalse3:00Tue, 05 Mar 2019 13:16:51 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190305-131651FDA 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-drugfalse3:00Tue, 05 Mar 2019 12:54:13 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190305-125413FDA 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-febuxostatfalseWed, 05 Sep 2018 12:01:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180905-120100FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabeteshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2falseMon, 06 Aug 2018 15:15:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180806-151500FDA Drug Safety Podcast: FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplanthttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-increased-risk-cancer-relapse-long-term-use-azithromycinfalseThu, 12 Jul 2018 09:32:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180712-093200FDA Drug Safety Podcast: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changeshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-andfalseFri, 01 Jun 2018 12:59:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180601-125900FDA 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 anestheticshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-risk-serious-and-potentially-fatal-blood-disorder-prompts-fda-action-oralfalseThu, 24 May 2018 08:35:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180524-083500FDA 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-medicinefalseMon, 30 Apr 2018 14:15:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180430-141500FDA 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-medicinefalseTue, 27 Feb 2018 09:35:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180227-093500FDA Drug Safety Podcast: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart diseasehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-finds-additional-data-supports-potential-increased-long-termfalseWed, 07 Feb 2018 14:44:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180207-144400FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver diseasehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-adds-boxed-warning-highlight-correct-dosing-ocaliva-obeticholic-acidfalseTue, 06 Feb 2018 15:08:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180206-150800FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe usehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-limits-packaging-anti-diarrhea-medicine-loperamide-imodium-encouragefalseTue, 16 Jan 2018 11:11:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180116-111100FDA Drug Safety Podcast: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and olderhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-requires-labeling-changes-prescription-opioid-cough-and-cold-medicinesfalseTue, 02 Jan 2018 10:26:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180102-102600FDA 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-longfalseThu, 21 Dec 2017 10:35:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20171221-103500FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warningshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-gadolinium-based-contrast-agents-gbcas-are-retained-body-requiresfalseMon, 20 Nov 2017 14:19:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20171120-141900FDA 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-goutfalseWed, 04 Oct 2017 16:50:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20171004-165000FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver diseasehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare-chronicfalseMon, 02 Oct 2017 11:48:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20171002-114800FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce riskshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-urges-caution-about-withholding-opioid-addiction-medications-patientsfalseThu, 14 Sep 2017 11:18:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170914-111800FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-recommends-separating-dosing-potassium-lowering-drug-sodium-polystyrenefalseFri, 26 May 2017 08:54:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170526-085400FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continuehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-identifies-no-harmful-effects-date-brain-retention-gadolinium-basedfalseThu, 25 May 2017 10:48:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170525-104800FDA 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-medicinefalseMon, 01 May 2017 13:07:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170501-130700FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young childrenhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-approves-label-changes-use-general-anesthetic-and-sedation-drugs-youngfalseThu, 27 Apr 2017 08:55:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170427-085500FDA Drug Safety Podcast: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding womenhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-restricts-use-prescription-codeine-pain-and-cough-medicines-and-tramadolfalseWed, 22 Mar 2017 08:19:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170322-081900FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladderhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-increased-risk-serious-pancreatitis-irritable-bowel-drugfalseWed, 08 Feb 2017 14:57:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170208-145700FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconatehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-rare-serious-allergic-reactions-skin-antisepticfalseWed, 28 Dec 2016 15:20:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20161228-152000FDA Drug Safety Podcast: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant womenhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-results-new-warnings-about-using-general-anesthetics-and-sedationfalseWed, 28 Dec 2016 15:20:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20161228-152000FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancerhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-updated-fda-review-concludes-use-pioglitazone-may-be-linked-increased-riskfalseWed, 28 Dec 2016 15:20:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20161228-152000FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findingshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-revises-description-mental-health-side-effects-stop-smoking-medicinesfalseFri, 07 Oct 2016 13:33:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20161007-133300FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis Chttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-risk-hepatitis-b-reactivating-some-patients-treated-directfalseWed, 07 Sep 2016 08:21:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160907-082100FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warninghttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-risks-and-death-when-combining-opioid-pain-or-coughfalseTue, 02 Aug 2016 11:19:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160802-111900FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effectshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-updates-warnings-oral-and-injectable-fluoroquinolone-antibiotics-duefalseTue, 21 Jun 2016 09:22:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160621-092200Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patchhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/update-fda-evaluating-risk-burns-and-scars-zecuity-sumatriptan-migraine-patchfalseTue, 21 Jun 2016 09:22:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160621-092200FDA 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-andfalseThu, 16 Jun 2016 09:01:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160616-090100FDA Drug Safety Podcast: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misusehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-heart-problems-high-doses-antidiarrheal-medicinefalseWed, 08 Jun 2016 10:05:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160608-100500FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patchhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-evaluating-risk-burns-and-scars-zecuity-sumatriptan-migraine-patchfalseWed, 08 Jun 2016 10:05:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160608-100500FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirinhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-bleeding-risk-over-counter-antacid-productsfalseFri, 03 Jun 2016 06:02:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160603-060200FDA Drug Safety Podcast: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient deathhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-prescribing-nizoral-ketoconazole-oral-tablets-unapproved-usesfalseThu, 26 May 2016 08:46:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160526-084600FDA 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 investigatehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-interim-clinical-trial-results-find-increased-risk-leg-and-foot-amputationsfalseWed, 25 May 2016 13:42:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160525-134200FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur togetherhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-advises-restricting-fluoroquinolone-antibiotic-use-certain-uncomplicatedfalseTue, 17 May 2016 14:58:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160517-145800FDA 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-olanzapinefalseFri, 06 May 2016 12:32:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160506-123200FDA 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-drugfalseFri, 06 May 2016 08:26:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160506-082600FDA 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-vortioxetinefalseTue, 03 May 2016 10:24:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160503-102400FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancyhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-study-examining-use-oral-fluconazole-diflucan-pregnancyfalseWed, 27 Apr 2016 15:09:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160427-150900FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failurehttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-announced-safety-review-has-found-type-2-diabetes-medicines-containing-saxagliptin-andfalseThu, 14 Apr 2016 12:07:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160414-120700FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney functionhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-revises-warnings-regarding-use-diabetes-medicine-metformin-certainfalseThu, 31 Mar 2016 08:49:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160331-084900FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changeshttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-several-safety-issues-opioid-pain-medicines-requires-labelfalseTue, 12 Jan 2016 08:23:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20160112-082300FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approvedhttp://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-cautions-about-dosing-errors-when-switching-between-different-oralfalse