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 Wed, 27 Apr 2016 03:45:00 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) 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 announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure. Wed, 27 Apr 2016 03:45:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm497914.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm497914.htm saxagliptin, diabetes, heart failure, alogliptin 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 FDA Drug Safety Podcast: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines On December 16, 2015, the FDA announced it is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. Wed, 30 Mar 2016 13:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm478280.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm478280.htm type 2 diabetes, Risk Evaluation and Mitigation Strategy, rosiglitazone, Drug Safety FDA Drug Safety Podcast: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections On December 4, 2015, FDA announced a safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of ketoacidosis and of serious urinary tract infections (UTIs). Both conditions can result in hospitalization. Wed, 30 Mar 2016 13:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm477234.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm477234.htm type 2 diabetes, SGLT2 inhibitors, risks of ketoacidosis, risks of serious urinary tract infections, Drug Safety FDA Drug Safety Podcast: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging On November 17, 2015, FDA announced it is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. Mon, 30 Nov 2015 16:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm474759.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm474759.htm cancer, risk of death, heart disease, Drug Safety FDA Drug Safety Podcast: FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death On November 6, 2015 FDA announced that a review has determined that long-term use of the blood-thinning drug Plavix (active ingredient clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. Tue, 10 Nov 2015 10:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm471976.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm471976.htm cancer, risk of death, heart disease, Drug Safety FDA Drug Safety Podcast: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone On October 26, 2015 FDA announced an FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. Fri, 06 Nov 2015 11:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm471147.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm471147.htm cardiovascular events, death, Drug Safety FDA Drug Safety Podcast: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie On October 22, 2015 FDA announced it is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. Fri, 30 Oct 2015 11:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm469702.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm469702.htm liver injury, ascites, hepatic encephalopathy, variceal hemorrhage, direct bilirubin, Drug Safety FDA Drug Safety Podcast: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate) On October 22, 2015, the FDA announced it is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work. Fri, 30 Oct 2015 11:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm469701.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm469701.htm lowering drug, drug interactions, Drug Safety