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, 15 May 2013 09:00 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) On May 14, 2013 the FDA notified the public that the Agency has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs. Wed, 15 May 2013 09:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm352351.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm352351.htm zolpidem, Ambien, Ambien CR, Edluar, sleep medication, Drug Safety On May 6, 2013 the FDA issued a Drug Safety Communication advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Tue, 07 May 2013 03:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm351109.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm351109.htm Valproate, anti-seizure, migraine, pregnancy, Drug Safety On May 6, 2013 the FDA alerted health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin, active ingredient trastuzumab, and may result in medication errors. Tue, 07 May 2013 03:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm351075.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm351075.htm Kadcyla, medication errors, Drug Safety On April 30, 2013 the FDA determined that the drug Samsca should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death. Wed, 01 May 2013 07:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm350282.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm350282.htm Samsca, tolvaptan, liver injury, Drug Safety On April 26, 2013 the FDA issued a drug safety communication warning the public that the anti-seizure medication Potiga can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. Tue, 30 Apr 2013 11:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm350120.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm350120.htm Potiga, ezogabine, retinal abnormalities, blue skin discoloration, Drug Safety On March 14, 2013 the FDA issued a Drug Safety Communication informing the public that it is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. Mon, 18 Mar 2013 05:51 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm344232.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm344232.htm incretin mimetic drugs, type 2 diabetes, pancreatitis, Drug Safety On March 12, 2013 the FDA issued a Drug Safety Communication warning the public that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Thu, 14 Mar 2013 08:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm343678.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm343678.htm Azithromycin, Zithromax, Zmax, fatal heart rhythms, Drug Safety On February 26, 2013, the FDA issued a Drug Safety Communication informing the public it has stopped all pediatric clinical trials of Sensipar after the recent death of a 14-year-old patient in a trial. FDA continues to gather information on the circumstances surrounding the patient's death. Wed, 27 Feb 2013 02:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm341518.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm341518.htm Sensipar, death, pediatrics, Drug Safety On February 20, 2013, the FDA issued an update to the public concerning new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy. Thu, 21 Feb 2013 12:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm340524.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm340524.htm codeine, pediatrics, Drug Safety On January 10, 2013, the Food and Drug Administration issued a Drug Safety Communication notifying the public of new information about zolpidem. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough, the morning after use, to impair activities that require alertness including driving. Fri, 11 Jan 2013 01:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm335262.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm335262.htm Zolpidem, impaired driving, Drug Safety On December 19, 2012, the FDA issued a Drug Safety Communication informing the public that the Agency has received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek in combination with the drugs peginterferon alfa and ribavirin, known as Incivek combination treatment. Wed, 26 Dec 2012 16:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333384.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333384.htm Incivek, skin reaction, telaprevir, peginterferon alfa, ribavarin, Drug Safety On December 17, 2012, the FDA issued a Drug Safety Communication reminding healthcare professionals and patients that the combined use of Xyrem with alcohol or CNS depressant drugs can markedly impair consciousness and may lead to respiratory depression. Fri, 21 Dec 2012 03:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333239.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333239.htm Xyrem, respiratory depression, Drug Safety On December 19, 2012, the FDA issued a Drug Safety Communication informing healthcare professionals and the public that the anticoagulant Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves. Fri, 21 Dec 2012 01:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333209.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm333209.htm Pradaxa, cardiovascular events, drug labeling, mechanical heart valves, Drug Safety On December, 12, 2012, the FDA issued a Drug Safety Communication informing the public about the results of a large, combined analysis of clinical trials that compared patients who received the smoking cessation drug Chantix to patients who received a placebo. Thu, 13 Dec 2012 02:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm332120.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm332120.htm Chantix, cardiovascular events, drug labeling, Drug Safety On December 6, 2012, the FDA issued a Drug Safety Communication notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products, which are blood-thinning agents that prevent the formation of blood clots. Thu, 13 Dec 2012 02:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm331264.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm331264.htm heparin, blood clots, drug labeling, Drug Safety