en FDA Drug Safety Podcast The FDA Drug Safety Podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. Thu, 02 Jan 2020 12:20:33 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 The FDA Drug Safety Podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. U.S. Food and Drug Administration, Center for Drug Evaluation and Research http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin 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/398907 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin Listen to an audio podcast of the December 19, 2019 FDA Drug Safety Communication warning that serious breathing difficulties may occur in patients using seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. 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/393151 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and Listen to an audio podcast of the August 28, 2019 FDA Drug Safety Communication: FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi with advanced liver disease. 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/390890 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and Listen to an audio podcast of the July 26, 2019 FDA Drug Safety Communication on FDA approval of Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR). 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/389685 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines 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/388692 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering 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/387766 http://www.fda.gov/drugs/fda-drug-safety-podcasts/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr 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 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/387765 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-symptoms-serious-condition-affecting-blood-cells-are-not-being-recognized-leukemia FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) 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/387764 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) Fri, 20 Dec 2019 20:21:06 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/387762 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) 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, 21 Mar 2019 21:54:28 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/370292 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 Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes Mon, 04 Mar 2019 09:55:22 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/378276 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2 FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Sat, 09 Feb 2019 03:38:29 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/378147 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-increased-risk-cancer-relapse-long-term-use-azithromycin FDA Drug Safety podcast on azithromycin (Zithromax, Zmax) antibiotic U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Sat, 09 Feb 2019 03:35:15 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/377928 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-and U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Sat, 09 Feb 2019 03:30:26 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/377599 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-risk-serious-and-potentially-fatal-blood-disorder-prompts-fda-action-oral U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) Sat, 09 Feb 2019 03:29:45 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/377400 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-evaluate-potential-risk-neural-tube-birth-defects-hiv-medicine FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) Sat, 09 Feb 2019 03:27:07 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/377044 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-serious-immune-system-reaction-seizure-and-mental-health-medicine U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Sat, 09 Feb 2019 03:18:46 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/376436 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-finds-additional-data-supports-potential-increased-long-term Listen to an audio podcast of the February 22, 2018 FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease. As a result, we have added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease Sat, 09 Feb 2019 03:16:08 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/376417 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-adds-boxed-warning-highlight-correct-dosing-ocaliva-obeticholic-acid Listen to an audio podcast of the February 1, 2018 FDA Drug Safety Communication warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, increasing the risk of serious liver injury. U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use Sat, 09 Feb 2019 03:15:46 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/376367 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-limits-packaging-anti-diarrhea-medicine-loperamide-imodium-encourage Listen to an audio podcast of the January 30, 2018 FDA Drug Safety Communication detailing serious heart problems with high doses of the antidiarrheal medicine loperamide, including from abuse and misuse. FDA announced it is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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 Sat, 09 Feb 2019 03:13:24 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research node/375940 http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-requires-labeling-changes-prescription-opioid-cough-and-cold-medicines Listen to an audio podcast of the January 11, 2018 FDA Drug Safety Communication requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. U.S. Food and Drug Administration, Center for Drug Evaluation and Research