Food and Drug Administration Drug Safety Podcast FDA Drug Safety Podcasts http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/default.htm en-us 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. Center for Drug Evaluation and Research druginfo@fda.hhs.gov (CDER Division of Drug Information) no Thu, 26 May 2016 11:00 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) 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 On May 18, 2016, FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (brand names Invokana, Invokamet). Thu, 26 May 2016 11:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503452.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503452.htm leg, foot, amputations, toes, diabetes, Drug Safety FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together On May 12, 2016 FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. Tue, 17 May 2016 15:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503021.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm503021.htm tendons, muscles, joints, nerves, and central nervous system, Drug Safety FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) On May 10, 2016, the U.S. Food and Drug Administration (FDA) announced it is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. Tue, 17 May 2016 15:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm501372.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm501372.htm new warning, DRESS, Drug Safety FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) On May 2, 2016, FDA announced it has approved a brand name change for the antidepressant Brintellix (active ingredient vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (active ingredient ticagrelor). Fri, 06 May 2016 08:35 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm499576.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm499576.htm antidepressant, brand name change, Drug Safety FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy On April 26, 2016 FDA announced that it is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (brand name Diflucan) for yeast infections. Tue, 03 May 2016 10:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm498830.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm498830.htm pregnancy, miscarriage, yeast infections, Drug Safety FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function On April 8, 2016 FDA announced it is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. Thu, 14 Apr 2016 12:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm496092.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm496092.htm diabetes, medicine, kidney function, Drug Safety FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes On March 22, 2016, FDA announced warnings about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks. Wed, 30 Mar 2016 13:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm493062.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm493062.htm opioids, Drug Safety FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved On January 4, 2016 FDA cautioned that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (active ingredient posaconazole) have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct milligram for milligram substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. Wed, 30 Mar 2016 13:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm481266.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm481266.htm fungal infections, dosing errors, posaconazole, Drug Safety