FDA Drug Safety Podcast http://www.fda.gov/about-fda/contact-fda/stay-informed/rss-feeds/drug-safety-podcast/rss.xml en 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 FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes 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 FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-bleeding-risk-over-counter-antacid-products 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 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr 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 FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-warns-symptoms-serious-condition-affecting-blood-cells-are-not-being-recognized-leukemia 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 FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) FDA 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 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 FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat 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 FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes FDA 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 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 FDA Drug Safety podcast on azithromycin (Zithromax, Zmax) antibiotic FDA 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: 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-reinforces-safety-information-about-serious-low-blood-sugar-levels-and 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-risk-serious-and-potentially-fatal-blood-disorder-prompts-fda-action-oral 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 FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) FDA 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 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-serious-immune-system-reaction-seizure-and-mental-health-medicine 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 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-finds-additional-data-supports-potential-increased-long-term 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 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. FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-adds-boxed-warning-highlight-correct-dosing-ocaliva-obeticholic-acid 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 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. FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-limits-packaging-anti-diarrhea-medicine-loperamide-imodium-encourage 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 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. FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-requires-labeling-changes-prescription-opioid-cough-and-cold-medicines 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 FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes-long 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 Listen to an audio podcast of the December 19, 2017 FDA Drug Safety Communication "FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings". This is an update to the FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue, issued May 22, 2017. FDA http://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-gadolinium-based-contrast-agents-gbcas-are-retained-body-requires 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 FDA 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