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, 26 Nov 2014 10:00 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) FDA Drug Safety Podcast: FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate) Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug information. On November 25, 2014, FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (active ingredient dimethyl fumarate), developed a rare and serious brain infection called PML or progressive multifocal leukoencephalopathy, and later died. Wed, 26 Nov 2014 10:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm424874.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm424874.htm death, brain infection, weakness, eyeslight, Drug Safety FDA Drug Safety Podcast: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug information. On November 16, 2014, FDA announced it is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. Fri, 21 Nov 2014 07:57 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm424193.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm424193.htm death, heart attacks, strokes, clot-related diseases, Drug Safety FDA Drug Safety Podcast: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug information. On June 26, 2014, FDA warned that prescription oral viscous lidocaine 2 percent solution should not be used to treat infants and children with teething pain. Fri, 27 Jun 2014 14:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm403125.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm403125.htm seizures, severe brain injury, heart problems, Drug Safety FDA Drug Safety Podcast: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products On June 25, 2014, FDA issued a warning that certain over-the-counter (or OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Fri, 27 Jun 2014 10:12 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm403033.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm403033.htm throat tightness, difficulty breathing, burning, dryness, itching, peeling, Drug Safety FDA Drug Safety Podcast: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required On June 24, 2014, FDA issued a Drug Safety Communication announcing that it has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with the use of the blood pressure medication olmesartan in diabetic patients. Fri, 27 Jun 2014 09:17 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm403003.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm403003.htm blood pressure, heart disease, stroke, kidney failure, Drug Safety FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots On June 19, 2014, FDA announced it is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins, also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism. Thu, 26 Jun 2014 14:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm402860.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm402860.htm blood clots, stroke, heart attack, death, Drug Safety FDA Drug Safety Podcast: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment On June 20, 2014, FDA issued a Drug Safety Communication warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. We are revising the labels of all docetaxel drug products to warn about this risk. Tue, 24 Jun 2014 10:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm402446.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm402446.htm alcohol intoxication, Drug Safety FDA Drug Safety Podcast: FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose On May 15, 2014, FDA issued a Drug Safety Communication warning that the insomnia drug Lunesta can cause next-day impairment of driving and other activities that require alertness. Fri, 16 May 2014 14:46 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm397733.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm397733.htm driving skills, memory, alertness, Drug Safety FDA Drug Safety Podcast: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin On May 13, 2014, FDA announced that in its ongoing review of the blood thinner Pradaxa (generic name dabigatran). Wed, 14 May 2014 14:56 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm397327.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm397327.htm gastrointestinal bleeding, stroke, death, Drug Safety FDA Drug Safety Podcast: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain On April 23, 2014, the FDA issued a statement warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. Fri, 25 Apr 2014 11:27 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm394852.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm394852.htm corticosteroids, injection, loss of vision, stroke, paralysis, death, Drug Safety FDA Drug Safety Podcast: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia On March 6, 2014, the FDA issued a statement concluding that Doribax (generic name doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to imipenem and cilastatin for injection (brand name Primaxin). Tue, 11 Mar 2014 11:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm388769.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm388769.htm antibacterial drug, pneumonia, label, death, Drug Safety FDA Drug Safety Podcast: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR) On February 11, 2014, the FDA announced that it requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the drug and heart failure. Wed, 12 Feb 2014 14:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm385776.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm385776.htm heart faliure, diabetes, Drug Safety