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 Tue, 11 Mar 2014 11:20 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) 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 FDA Drug Safety Podcast: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products On January 31, 2014, FDA announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA approved testosterone products. Wed, 05 Feb 2014 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm384684.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm384684.htm stroke, heart attack, death, testosterone, Drug Safety FDA Drug Safety Podcast: FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation On January 8, 2014, FDA is warning the public that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. Fri, 10 Jan 2014 13:47 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm381228.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm381228.htm OTC, sodium phosphate, constipation, Drug Safety FDA Drug Safety Podcast: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing On December 20th, 2013, the FDA issued a drug safety communication informing the public that the Agency is requiring several new safety measures for the leukemia drug Iclusig (active ingredient ponatinib) to address the risk of life-threatening blood clots and severe narrowing of blood vessels. Thu, 26 Dec 2013 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm379840.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm379840.htm Iclusig, ponatinib, blood clots, narrowing of blood vessels, Drug Safety FDA Drug Safety Podcast: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes On December 17th, 2013, the FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (or ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. Thu, 19 Dec 2013 10:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm379162.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm379162.htm methyphenidate, ADHD medication, priapism, Drug Safety FDA Drug Safety Podcast: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes On December 3rd, 2013 the U.S. Food and Drug Administration is warning the public that the anti-seizure drug Onfi (active ingredient clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. Thu, 12 Dec 2013 03:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm378483.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm378483.htm Onfi, clobazam, skin reactions, Drug Safety FDA Drug Safety Podcast: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines On November 25th, 2013 the U.S. Food and Drug Administration issued a DSC notifying the public it has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. Tue, 26 Nov 2013 11:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm376805.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm376805.htm rosiglitazone-containing drugs, Avandia, Avandamet, Avandaryl, heart attack risk, Drug Safety FDA Drug Safety Podcast: FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine) On November 20th, 2013 the U.S. Food and Drug Administration (or FDA) is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (active ingredient regadenoson) and Adenoscan (active ingredient adenosine). Fri, 22 Nov 2013 06:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm376187.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm376187.htm heart attack, death, cardiac nuclear stress test, Drug Safety FDA Drug Safety Podcast: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection On November 13, 2013, the FDA issued a Drug Safety Communication requesting label and packaging changes to enhance the safe use of certain over-the-counter (or OTC) topical antiseptic products. Mon, 18 Nov 2013 11:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm375279.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm375279.htm over-the-counter antiseptic products, infection, labeling, packaging, Drug Safety FDA Drug Safety Podcast: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins On November 6th, 2013 the FDA issued a Drug Safety Communication recommending health care professionals to carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. Fri, 08 Nov 2013 02:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm374344.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm374344.htm heparin, spinal column bleeding, paralysis, Drug Safety FDA Drug Safety Podcast: FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration On October 31, 2013, the FDA issued a drug safety communication informing the public that the Agency has approved changes to the drug label of the anti-seizure drug Potiga (active ingredient ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent. Fri, 01 Nov 2013 11:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm373245.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm373245.htm Potiga, ezogabine, retinal abnormalities, vision loss, skin discoloration, Drug Safety FDA Drug Safety Podcast: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales On October 31st, 2013 the FDA issued a Drug Safety Communication notifying the public it has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Fri, 01 Nov 2013 11:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm373240.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm373240.htm Iclusig, ponatinib, blood clots, Drug Safety FDA Drug Safety Podcast: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins On October 11, 2013, On October 11th, 2013, the U.S. Food and Drug Administration announced it is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig. Thu, 17 Oct 2013 03:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm371193.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm371193.htm Iclusig, ponatinib, blood clots, Drug Safety FDA Drug Safety Podcast: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning On September 27, 2013, the FDA issued a Drug Safety Communication (or DSC) warning that an additional analysis shows an increased risk of death when intravenous (or IV) Tygacil (or tigecycline) is used for FDA-approved uses as well as for non-approved uses. Tue, 01 Oct 2013 02:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm370626.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm370626.htm Tygacil, tigecycline, boxed warning, Drug Safety FDA Drug Safety Podcast: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) On September 25, 2013, the FDA issued a Drug Safety Communication announcing that the FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (or ofatumumab) and Rituxan (or rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (or HBV) infection. Thu, 26 Sep 2013 01:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm370070.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm370070.htm Arzerra, ofatumumab, Rituxan, rituximab, Drug Safety FDA Drug Safety Podcast: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety?emphasizing that accidental exposure to used patches can cause death On September 23, 2013, the FDA issued a Drug Safety Communication announcing that the Agency is requiring color changes to the writing on Duragesic (or fentanyl) pain patches so they can be seen more easily. This is part of an effort to prevent accidental exposure to the patches, which can cause serious harm and death in children, pets, and others. Tue, 24 Sep 2013 10:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm369597.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm369597.htm Fentanyl, Duragesic, pain patches, Drug Safety FDA Drug Safety Podcast: FDA investigating rare brain infection in patient taking Gilenya (fingolimod) On August 29, 2013, the FDA issued a Drug Safety Communication alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (or MS) has developed a rare and serious brain infection after taking the drug Gilenya. Fri, 30 Aug 2013 12:33 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm366933.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm366933.htm Gilenya, multiple sclerosis, MS, Drug Safety FDA Drug Safety Podcast: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection On August 15th, 2013 the FDA issued a Drug Safety Communication notifying the public it has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. Fri, 16 Aug 2013 12:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm365346.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm365346.htm fluoroquinolone, periphera neuropathy, nerve damage, Drug Safety FDA Drug Safety Podcast: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen On August 1, 2013, the FDA issued a Drug Safety Communication informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. Thu, 01 Aug 2013 03:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm363918.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm363918.htm acetaminophen, skin reactions, Drug Safety FDA Drug Safety Podcast: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects On July 29, 2013, the FDA issued a Drug Safety Communication advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. Mon, 29 Jul 2013 01:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm362919.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm362919.htm mefloquine hydrochloride, antimalarial, psychiatric side effects, nerve side effects, Drug Safety FDA Drug Safety Podcast: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems On July 26th, 2013 the Food and Drug Administration issued a Drug Safety Communication notifying the public of several actions it is taking related to Nizoral (or ketoconazole) oral tablets, including limiting the drug's use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications. Mon, 29 Jul 2013 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm362820.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm362820.htm Nizoral, ketoconazole, liver injury, drug interactions, adrenal gland problems, Drug Safety FDA Drug Safety Podcast: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil On July 3rd, 2013, the FDA issued a Drug Safety Communication warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. FDA has approved changes to the labels of these drugs to include this concern. Fri, 05 Jul 2013 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm359623.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm359623.htm olmesartan medoxomil, Benicar, Benicar HCT, Azor, Tribenzor, intestinal problems, Drug Safety FDA Drug Safety Podcast: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) On June 18, 2013, the FDA issued a Drug Safety Communication informing the public that the Agency is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv, active ingredient olanzapine pamoate. Tue, 18 Jun 2013 03:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm357659.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm357659.htm Zyprexa Relprevv, olanzapine pamoate, death, Drug Safety FDA Drug Safety Podcast: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies On May 30, 2013 the FDA advised health care professionals against using magnesium sulfate injection for more than 5 to 7 days to stop pre-term labor in pregnant women. Fri, 31 May 2013 02:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm354762.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm354762.htm magnesium sulfate, pregnancy, Drug Safety FDA Drug Safety Podcast: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use 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 FDA Drug Podcast: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children 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 FDA Drug Safety Podcast: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) 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 FDA Drug Safety Podcast: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death 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 FDA Drug Safety Podcast: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration 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 FDA Drug Safety Podcast: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes 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 FDA Drug Safety Podcast: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms 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 FDA Drug Safety Podcast: FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death 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 FDA Drug Safety Podcast: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy 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 FDA Drug Safety Podcast: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem 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 FDA Drug Safety Podcast: Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin 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 FDA Drug Safety Podcast: Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression 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 FDA Drug Safety Podcast: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves 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 FDA Drug Safety Podcast: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events 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 FDA Drug Safety Podcast: Important change to heparin container labels to clearly state the total drug strength 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