Food and Drug Administration Safety Podcast FDA Drug Safety Podcasts http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/default.htm en-us http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyPodcasts/UCM166826.xml 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, 13 Oct 2011 12:00 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) FDA Drug Safety Podcast for Healthcare Professionals: Sprycel (dasatinib) and risk of pulmonary arterial hypertension On October 11, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that the leukemia drug Sprycel, active ingredient dasatinib, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, known as pulmonary arterial hypertension, or PAH. Thu, 13 Oct 2011 12:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm275517.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm275517.htm Sprycel, dasatinib, pulmonary arterial hypertension, PAH, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone On September 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. Fri, 30 Sep 2011 12:17 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm274005.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm274005.htm Drosperinone, birth control, blood clots, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms may be associated with use of Zofran (ondansetron) On September 15, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of an ongoing safety review of the anti-nausea drug Zofran, active ingredient ondansetron, ondansetron hydrochloride and their generics. Fri, 16 Sep 2011 12:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm272160.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm272160.htm Zofran, ondansetron, heart rhythms, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Drug labels for the Tumor Necrosis Factor-alpha (TNFa) blockers now include warnings about infection with Legionella and Listeria bacteria On September 7, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha, or TNFa, blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. Thu, 08 Sep 2011 08:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm271154.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm271154.htm Tumor Necrosis Factor-alpha, TNFa, Legionella, listeria, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Serious allergic reactions reported with the use of Saphris (asenapine maleate) On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris, active ingredient asenapine maleate. Fri, 02 Sep 2011 11:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm270673.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm270673.htm Saphris, asenapine maleate, allergic reactions, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid) On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA has approved an update to the drug label for Reclast, active ingredient zoledronic acid, to better inform healthcare professionals and patients of the risk of renal failure. Fri, 02 Sep 2011 09:38 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm270654.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm270654.htm Reclast, zoledronic acid, renal failure, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Updated drug labels for pioglitazone-containing medicines On August 4, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. Tue, 09 Aug 2011 11:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm267287.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm2672875.htm Actos, pioglitazone, bladder cancer, podcast, Drug Safety FDA Drug Safety Podcast: Long-term, high dosage use of Diflucan during pregnancy may lead to rare birth defects On August 3, 2011 the Food and Drug Administration issued a Drug Safety Communication that explains how long-term, high dosage use of diflucan during pregnancy may be associated with rare birth defects. Tue, 09 Aug 2011 07:35 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm267095.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm267095.htm Diflucan, fluconazole, birth defects, podcast, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death On August 4, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of recombinant human growth hormone, or somatropin, and possible increased risk of death. Fri, 05 Aug 2011 13:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266905.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266905.htm Somatropin, Recombinant Human Growth Hormone, podcast, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants On August 3, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan, active ingredient fluconazole, may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy. Fri, 05 Aug 2011 13:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266879.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266879.htm Diflucan, fluconazole, birth defects, podcast, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography, or PET, scans. The manufacturer, Bracco Diagnostics, Inc. has decided to voluntarily recall CardioGen-82. Tue, 02 Aug 2011 16:18 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266403.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266403.htm podcast, CardioGen-82, radiation exposure, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) drug label now contains updated efficacy and safety information On July 22, 2011, the Food and Drug Administration issued a Drug Safety Communication informing that public that FDA has approved an updated drug label for the smoking cessation aid Chantix, active ingredient varenicline, to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking -- those with cardiovascular disease and those with chronic obstructive pulmonary disease, or COPD. Tue, 02 Aug 2011 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266365.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266365.htm podcast, Chantix, varenicline, labeling, cardiovascular disease, COPD, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: FDA Drug Safety Podcast for Healthcare Professionals: Serious CNS reactions possible when linezolid (Zyvox.) is given to patients taking certain psychiatric medications On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of reports of serious central nervous system reactions when the drug methylene blue is given to patients taking serotonergic psychiatric medications. Tue, 02 Aug 2011 11:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266292.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266292.htm podcast, linezolid, Zyvox, CNS, Central Nervervous system, psychiatric, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of reports of serious central nervous system reactions when the drug methylene blue is given to patients taking serotonergic psychiatric medications. Mon, 01 Aug 2011 04:41 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266219.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266219.htm podcast, methaline blue, CNS, Central Nervervous system, psychiatric, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer On July 21, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. There have been conflicting findings from studies evaluating this risk. Thu, 21 Jul 2011 01:41 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm264096.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm264096.htm podcast, bisphosphonates, esophageal cancer, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans On July 15, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting the public; in particular, the medical imaging community; about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography, or PET, scans with rubidium (Rb)-82 chloride injection from CardioGen-82 (manufactured by Bracco Diagnostics, Inc.). Tue, 19 Jul 2011 10:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm263484.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm263484.htm podcast, CardioGen-82, PET scans, radiation exposure, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension On July 11, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of important product safety changes to the influenza drug Tamiflu, active ingredient oseltamivir phosphate, for oral suspension. Tue, 12 Jul 2011 10:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm262605.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm262605.htm podcast, tamiflu, oseltamivir, flu, influenza, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development On June 30, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products, such as valproic acid and divalproex sodium, during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. Fri, 01 Jul 2011 11:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm261653.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm261653.htm podcast, valproate, pregnancy, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease On June 24, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals of modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease, or CKD, to improve the safe use of these drugs. Mon, 27 Jun 2011 14:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm260913.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm260913.htm podcast, ESAs, Aranesp, Epogen, Procrit, chronic kidney disease, Drug Safety Bad Ad Looks Good in Year One A year ago, the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) launched the Bad Ad program. The goal of Bad Ad is to encourage health care professionals to recognize and report suspected untruthful or misleading drug promotion. Thu, 23 Jun 2011 14:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm260556.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm260556.htm Bad Ad, Ethic Ad, Drug Safety FDA Drug Safety Podcast: Chantix may increase cardiovascular risk in certain patients On June 16, 2011 the Food and Drug Administration issued a drug safety communication informing the public that the prescription smoking cessation aid Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease Fri, 17 Jun 2011 16:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm259791.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm259791.htm Chantix, varenicline, cardio vascular disease, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease On June 16, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. Thu, 16 Jun 2011 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm259513.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm259513.htm Chantix, varenicline, cardio vascular disease, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer) On June 15, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Thu, 16 Jun 2011 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm259489.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm259489.htm Actos, pioglitazone, bladder cancer, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip) On June 13, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting the public to medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized. Tue, 14 Jun 2011 09:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm258973.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm258973.htm risperidone, Risperdal, ropinirole, Requip, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer On June 9, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor, or 5-ARI, class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer, or high-grade prostate cancer. Fri, 10 Jun 2011 14:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm258703.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm258703.htm 5-ARI, 5-alpha redutctase inhibitors, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury On June 8, 2011, the Food and Drug Administration issued a Drug Safety Communication recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage. Thu, 09 Jun 2011 09:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm258399.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm258399.htm Zocor, Simvastatin, muscle injury, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs) On June 2, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public it has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers, also known as ARBs. Fri, 03 Jun 2011 11:57 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm257719.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm257719.htm Angiotensin Receptor Blockers, ARBs, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone On May 31, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public about new information that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. Wed, 01 Jun 2011 03:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm257567.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm257567.htm drospirenone, birth control, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl On May 18, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. Fri, 20 May 2011 09:55 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm256039.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm256039.htm rosiglitazone, Avandia, Avandamet, Avandaryl, REMS, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone On May 6, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the cardiac drugs adenosine and amiodarone are used with particular types of intravenous access systems. Wed, 11 May 2011 08:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm254936.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm254936.htm adenosine, amiodarone, needleless pre-filled glass syringes, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab) On April 22, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA continues to evaluate the risk of progressive multifocal leukoencephalopathy, or PML, a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis, or MS, and Crohn's disease. Tue, 26 Apr 2011 11:55 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm252677.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm252677.htm Tysabri, PML, Progressive Multifocal Leukoencephalopathy, Drug Safety FDA Drug Safety Podcast: Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of an international agreement to stop the use of substances that damage the environment. Wed, 20 Apr 2011 15:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm252120.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm252120.htm primatene mist, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine On April, 14, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL). Mon, 18 Apr 2011 14:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm251809.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm251809.htm TNF Blocker, tumor necrosis factor, azathioprine,mercaptopurine, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies On April 8, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid, active ingredient lenalidomide, may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. Fri, 15 Apr 2011 08:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm251421.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm251421.htm revlimid, lenalidomide, cancer risk, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures On April 7, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting healthcare professionals that the Agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine sprays. Mon, 11 Apr 2011 08:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm250623.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm250623.htm benzocaine, methemboglobinemia, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth On April 7, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that the use of benzocaine, the main ingredient in over-the-counter, or OTC, gels and liquids applied to the gums or mouth to reduce pain, is associated with a rare, but serious condition. Mon, 11 Apr 2011 08:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm250614.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm250614.htm benzocaine, methemboglobinemia, Drug Safety FDA Drug Safety Podcast: Risk of Low Magnesium Levels Associated with Long-Term Use of Proton Pump Inhibitors On March 2, 2011 the Food and Drug Administration issued a drug safety communication that states that prolonged use of prescription proton pump inhibitors may cause low magnesium levels. Mon, 14 Mar 2011 13:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm246866.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm246866.htm proton pump inhibitors, PPDs, low magnesium, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution On March 8, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution. Thu, 10 Mar 2011 09:18 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm246459.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm246459.htm Kaletra, lopinavir, ritonavir, premature babies, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Liver injury warning to be removed from Letairis (ambrisentan) tablets On March 4, 2011, the Food and Drug Administration issued a Drug Safety Communication removing the warning related to liver injury from the boxed warning of the Letairis (active ingredient ambrisentan) tablet label. Mon, 07 Mar 2011 08:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm246074.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm246074.htm Letairis, ambrisentan, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Risk of oral clefts in children born to mothers taking Topamax (topiramate) On March 4, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (also known as oral clefts) in infants born to women treated with Topamax, or topiramate, during pregnancy. Mon, 07 Mar 2011 08:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245877.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245877.htm topamax, topiramate, oral clefts, pregnancy, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns On February 22, 2011 the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements, including extrapyramidal signs or EPS, and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy. Fri, 04 Mar 2011 11:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245709.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245709.htm antipsychotic drugs, pregnancy, newborns, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs) On March 2, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that prescription proton pump inhibitor, or PPI, drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Thu, 03 Mar 2011 16:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245455.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245455.htm PPIs, proton pump inhibitors, low magnesium, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Safety Review update of Abacavir and possible increased risk of heart attack On March 1, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of abacavir and a possible increased risk of heart attack. Thu, 03 Mar 2011 09:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245452.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm245452.htm Abacavir, heart attack, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: New warnings against use of terbutaline to treat preterm labor On February 17, 2011 the Food and Drug Administration issued a Drug Safety Communication warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. Thu, 24 Feb 2011 11:35 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm244130.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm244130.htm terbutaline, pregnancy, pre-term labor, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients On February 3, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug. Tue, 08 Feb 2011 10:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm242588.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm242588.htm avandia, cardiovascular risk, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure On January 13, 2011, the Food and Drug Administration issued a Drug Safety Communication asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. Thu, 20 Jan 2011 12:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm240513.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm240513.htm acetaminophen, prescription, liver injury, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer On January 12, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Thu, 20 Jan 2011 12:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm240508.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm240508.htm Lantus, insulin glargine, cancer risk, Drug Safety FDA Drug Safety Podcast: FDA reduces dose of acetaminophen in combination prescription products On January 13, 2011, the Food and Drug Administration issued a drug safety communication announcing that all prescription combinations of opioids and acetaminophen can no longer contain more than 325mg of acetaminophen per tablet. Fri, 14 Jan 2011 12:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm240045.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm240045.htm acetaminophen, prescription, liver injury, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death On December 22, 2010, the Food and Drug Administration issued a Drug Safety Communication informing the public about results from a study conducted in France -- the Santi Adulte GH Enfant, or SAGhE, study. Wed, 29 Dec 2010 13:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm238349.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm238349.htm somatropin, recombinant human growth hormone, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate) On December 17, 2010, the Food and Drug Administration issued a Drug Safety Communication informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in pediatric and adult patients. Wed, 22 Dec 2010 08:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm237742.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm237742.htm Anzemet, dolasetron, abnormal heart rhythms, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age On December 14, 2010, the Food and Drug Administration issued a Drug Safety Communication warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Mon, 20 Dec 2010 08:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm237266.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm237266.htm Tessalon, benzonatate, children, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: FDA recommends against the continued use of propoxyphene On November 19, 2010, the Food and Drug Administration issued a Drug Safety Communication recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. Tue, 30 Nov 2010 14:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm235226.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm235226.htm Propoxyphene, withdrawal of products, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems On November 17, 2010 FDA issued a Stakeholder Advisory notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous, or IV, access systems. Tue, 30 Nov 2010 14:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm235187.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm234187.htm Glass Sryinge, adenosine, amiodarone, Drug Safety FDA Drug Safety Podcast: Withdrawal of Products that Contain Propoxyphene On November 19, 2010 the Food and Drug Administration issued a drug safety communication about the withdrawal of products that contain propoxyphene. Sun, 21 Nov 2010 14:14 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm234455.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm234455.htm Propoxyphene, withdrawal of products, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms On October 21, 2010, the Food and Drug Administration issued a Drug Safety Communication notifying the public that new risk information has been added to the label of the antiviral drug Invirase, or saquinavir, describing a potential change in the electrical activity of the heart when Invirase is used with another antiviral medication, Norvir, or ritonavir. Mon, 25 Oct 2010 16:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm230911.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm230911.htm Invirase, saquinavir, abnormal heart rhythms, Norvir, ritonavir, Drug Safety FDA Drug Safety Podcast for Healthcare Professionals: Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH Agonists to Add New Safety Information to Labeling Regarding Increased Risk of Diabetes and Certain Cardiovascular Diseases On October 20, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication updating the public that FDA has notified the manufacturers of the Gonadotropin-Releasing Hormone, or GnRH, agonists of the need to add new safety information to the Warnings and Precautions section of the drug labels. Thu, 21 Oct 2010 13:19 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm230464.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm230464.htm GnRH Agonists, diabetes, cardiovascular disease, Drug Safety FDA Drug Safety Podcast: FDA issues warnings to marketers of unapproved 'chelation' products On October 14, the FDA warned eight companies that their over-the-counter or OTC chelation products are unapproved drugs and devices. There are no FDA-approved OTC chelation products. Tue, 19 Oct 2010 09:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm230098.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm230098.htm Drug Safety, chelation products, unapproved drugs FDA Drug Safety Podcast for Healthcare Professionals: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures On October 13, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. Mon, 18 Oct 2010 09:54 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm229800.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm229800.htm Drug Safety, bisphosphonates, fractures FDA Drug Safety Podcast for Healthcare Professionals: FDA Recommends Against the Continued Use of Meridia (sibutramine) On October 8, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication recommending against continued prescribing and use of Meridia, or sibutramine, because this drug may pose unnecessary cardiovascular risks to patients. Wed, 13 Oct 2010 15:12 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm229245.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm229245.htm Drug Safety, Meridia, cardiovascular risks FDA Drug Safety Podcast: FDA significantly restricts access to the diabetes drug Avandia On September 23, the Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications. Tue, 28 Sep 2010 14:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm227511.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm227511.htm Drug Safety, Avandia, rosiglitazone, diabetes FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure On September 17, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication announcing that the agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos, or pioglitazone, is associated with an increased risk of bladder cancer. Wed, 22 Sep 2010 10:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm226749.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm226749.htm Drug Safety, Actos, pioglitazone, bladder cancer, cancer FDA Drug Safety Podcast for Healthcare Professionals: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients On September 15, 2010, the Food and Drug Administration issued a Drug Safety Communication notifying healthcare professionals of new pediatric dosing recommendations for Valcyte, also known as valganciclovir hydrochloride, oral tablets and oral solution. Mon, 20 Sep 2010 09:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm226094.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm226094.htm Drug Safety, Valcyte, valganciclovir, pediatric, transplantation FDA Drug Safety Podcast for Healthcare Professionals: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction On September 9, 2010, the Food and Drug Administration issued a Drug Safety Communication requiring changes in the drug label for gadolinium-based contrast agents, or GBCAs, to minimize the risk of nephrogenic systemic fibrosis, or NSF, a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. Mon, 13 Sep 2010 11:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm225578.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm225578.htm Drug Safety, GBCA, gadolinium-based contrast agents, kidney, NSF, nephrogenic systemic fibrosis FDA Drug Safety Podcast: FDA Warns Consumers to Avoid TimeOut Capsules FDA is warning consumers not to take TimeOut Capsules, a product marketed as a dietary supplement for sexual enhancement. Wed, 8 Sep 2010 11:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm225150.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm225150.htm Drug Safety, TimeOut FDA Drug Safety Podcast for Healthcare Professionals: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections Food and Drug Administration issued a drug safety communication reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil, or tigecycline, compared to that of other drugs used to treat a variety of serious infections. . Fri, 3 Sep 2010 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm224896.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm224896.htm Drug Safety, Tygacil, tigecycline, antibiotics, intravenous antibacterial FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk FDA is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events, such as heart attack, stroke, and cardiovascular death, compared to those taking carbidopa/levodopa which is sold as the combination product, Sinemet. Mon, 23 Aug 2010 11:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm223620.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm223620.htm Drug Safety, Stalevo, carbidopa, levodopa, carbidopa/levodopa, entacapone, Sinemet FDA Drug Safety Podcast for Healthcare Professionals: Aseptic meningitis associated with use of Lamictal Update on the recent drug safety communication from the FDA informing the public that Lamictal, or lamotrigine, a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. Thu, 19 Aug 2010 10:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm223161.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm223161.htm Drug Safety, Lamictal, lamotrigine, aseptic meningitis FDA Drug Safety Podcast for Healthcare Professionals: Serious medication errors from intravenous administration of nimodipine oral capsules Update on the recent drug safety communication from the FDA alerting healthcare professionals that nimodipine capsules should be given ONLY by mouth or through a feeding tube or nasogastric tube. Thu, 19 Aug 2010 10:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm223178.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm223178.htm Drug Safety, Nimodipine, medication error, IV FDA Drug Safety Podcast: Aseptic meningitis associated with use of Lamictal On August 12, 2010 the Food and Drug Administration issued a Drug Safety Communication titled: Aseptic meningitis associated with use of Lamictal. Mon, 16 Aug 2010 15:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm222620.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm222620.htm Drug Safety, Lamictal, lamotrigine, aseptic meningitis FDA Drug Safety Podcast: Avoid Unintentional Exposure of Children and Pets to Evamist On July 30, 2010, the Food and Drug Administration (FDA) issued a drug safety communication about the unintentional exposure of children and pets to Evamist. Thu, 12 Aug 2010 11:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm221529.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm221529.htm Drug Safety, Evamist, estradiol transdermal spray, estradiol, transdermal spray FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen Informing you about FDA's ongoing safety review of adverse event reports in children who may have been unintentionally exposed to the drug through skin contact with women using Evamist. Wed, 04 Aug 2010 10:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm220988.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm220988.htm Drug Safety, Evamist, estradiol transdermal spray, estradiol, transdermal spray FDA Drug Safety Podcast for Healthcare Professionals: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) Updating you about the potential for developing eosinophilic pneumonia during treatment with the intravenous antiobiotic Cubicin or daptomycin. Wed, 04 Aug 2010 10:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm220936.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm220936.htm Drug Safety, Cubicin, daptomycin, intravenous, IV, antibiotic FDA Drug Safety Podcast for Healthcare Professionals: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide) FDA is adding information on severe liver injury to the Boxed Warning of leflunomide to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. Tue, 20 Jul 2010 15:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm219584.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm219584.htm Drug Safety, Arava, Leflunomide, liver, arthritis Drug Safety Podcast for Healthcare Professionals: New risk management plan and patient Medication Guide for Qualaquin Qualaquin is ONLY FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, a rare infection in the United States, seen primarily in travelers returning from malaria-endemic areas. However, the majority of Qualaquin's use in the United States is for the treatment or prevention of night time leg cramps, a use NOT approved by FDA. Fri, 16 Jul 2010 15:18 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm219331.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm219331.htm Drug Safety, Qualaquin, malaria, leg cramps, medication guide Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Benicar and cardiovascular events The FDA is evaluating data from two clinical trials ROADMAP and ORIENT in which patients with type 2 diabetes taking Benicar, also known as olmesartan, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. Thu, 01 Jul 2010 11:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm217335.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm217335.htm Drug Safety, Benicar, cardiovascular, high blood pressure Drug Safety Podcast for Healthcare Professionals: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors FDA is revising the prescription and over-the-counter labels for proton pump inhibitors, or PPIs, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. Fri, 04 Jun 2010 14:55 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm214472.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm214472.htm Drug Safety, fractures, proton pump inhibitors Drug Safety Podcasts for Healthcare Professionals: Completed safety review of Xenical/Alli (orlistat) and severe liver injury On May 26, 2010, The U.S. Food and Drug Administration (FDA) has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. Thu, 03 Jun 2010 11:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm214341.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm214341.htm Drug Safety, Orlistat, Alli, Xenical, healthcare professional, liver Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel On May 12, 2010, the Food and Drug Administration issued a drug safety communication titled: Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel. Thu, 20 May 2010 17:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm212478.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm212478.htm Drug Safety, Benadryl Extra Strength Itch Stopping Gel Drug Safety Podcasts for Healthcare Professionals: Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases On May 3rd, 2010, FDA announced that the agency is evaluating whether GnRH Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. Fri, 7 May 2010 12:07 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm211169.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm211169.htm Drug Safety, healthcare professional, GnRH agonists, diabetes, cardiovascular diseases Drug Safety Podcasts for Healthcare Professionals: New Boxed Warning on severe liver injury with propylthiouracil FDA has now added a Boxed Warning to the label for propylthiouracil, a drug used to treat hyperthyroidism, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication. Mon, 26 Apr 2010 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm209781.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm20209781.htm Drug Safety, healthcare professional, PTU, propylthiouracil Questions and Answers:Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil On April 13, 2010 the Food and Drug Administration issued a drug safety communication titled: Questions and Answers: Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil Thu, 22 Apr 2010 09:57 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm209072.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm20209072.htm Drug Safety, healthcare professional, CFC Metered-Dose Inhalers, flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, nedocromil Podcast for Healthcare Professionals: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph Update about a follow-up to an October 2009 Public Health Alert about changes to the United States Pharmacopeia or USP monograph for heparin sodium. Thu, 15 Apr 2010 09:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm208545.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm208545.htm Drug Safety, healthcare professional, heparin Podcast for Healthcare Professionals: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer Update about an ongoing safety review of Stalevo and an increased risk for developing prostate cancer. Wed, 07 Apr 2010 11:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm207688.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm207688.htm Drug Safety, healthcare professional, stalevo, prostate cancer Podcast for Healthcare Professionals: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures Healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures -- fractures in the bone just below the hip joint. Wed, 17 Mar 2010 14:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm204950.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm204950.htm Drug Safety, healthcare professional, bisphosphonates, atypical subtrochanteric femur fractures Podcast for Healthcare Professionals:Reduced effectiveness of Plavix in patients who are poor metabolizers of the drug The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the drug label for Plavix. Wed, 17 Mar 2010 14:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm204572.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm204572.htm Drug Safety, healthcare professional, Plavix, Boxed Warning Podcast for Healthcare Professionals:Ongoing review of Avandia and Cardiovascular Safety The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone). Wed, 17 Mar 2010 14:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm204285.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm204285.htm Drug Safety, healthcare professional, Avandia, cardiovascular safety Podcast for Healthcare Professionals:Ongoing Safety Review of Invirase and Possible Association with Abnormal Heart Rhythms The U.S. Food and Drug Administration (FDA) is reviewing data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir). Mon, 1 Mar 2010 11:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201889.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201889.htm Drug Safety, Invirase, Norvir, Abnormal heart rhythms, saquinavir, ritonavir, healthcare professional Podcast for Healthcare Professionals: Serious Liver Disorder Associated with the Use of Videx/Videx EC The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals about a rare, but serious adverse event in the liver, non-cirrhotic portal hypertension, associated with the use of didanosine, marketed as Videx and Videx EC, a delayed-release version of Videx. Mon, 1 Mar 2010 11:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201863.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201863.htm Drug Safety, Videx, Liver Disorder, didanosine, healthcare professional Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs) On February 18, 2010 the Food and Drug Administration issued a drug safety communication titled: Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs) Tue, 23 Feb 2010 13:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201144.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201144.htm LABA, Long-Acting Beta Agonists, Safety Requirements Product Confusion with Maalox Total Relief and Maalox Liquid Products The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products. Tue, 23 Feb 2010 13:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201098.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm201098.htm Maalox, Confusion,Maalox Total Relief Availability of Tamiflu for Oral Suspension Full Version FDA is informing healthcare professionals and consumers that additional quantities of the commercially prepared Tamiflu for Oral Suspension are being shipped to wholesalers and pharmacies. Mon, 14 Dec 2009 10:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm193983.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm193983.htm Tamiflu, Flu, Influenza Availability of Tamiflu for Oral Suspension Overview FDA is informing healthcare professionals and consumers that additional quantities of the commercially prepared Tamiflu for Oral Suspension are being shipped to wholesalers and pharmacies. Mon, 14 Dec 2009 10:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm193977.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm193977.htm Tamiflu, Flu, Influenza Epinephrine CFC Metered-dose Inhalers - Questions and Answers Epinephrine CFC metered-dose inhalers used to treat asthma, known as Primatene Mist or Epinephrine Mist, cannot be made or sold in the United States after December 31, 2011. Tue, 29 Sep 2009 10:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm183944.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm183944.htm Metered-Dose Inhalers, Epinephrine, CFC The FDA recommends that consumers should not use body building products marketed as containing steroids or steroid-like substances On July 28, 2009, the Food and Drug Administration issued a public health advisory titled: The FDA recommends that consumers should not use body building products marketed as containing steroids or steroid-like substances. Thu, 30 Jul 2009 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm174113.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm174113.htm Body Building,Supplement,Steroid FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban On July 1, 2009, the Food and Drug Administration issued a public health advisory titled: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban. Wed, 8 Jul 2009 09:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm170906.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm170906.htm Chantix, Zyban, Smoking Cessation FDA Public Health Advisory: Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc On June 16, 2009, the Food and Drug Administration issued a public health advisory titled: Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc Fri, 19 Jun 2009 09:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm167282.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm167282.htm Zicam, zinc, cold remedies FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions: Overview Version Fri, 16 Jan 2009 11:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm079040.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm079040.htm topical anesthetics, skin numbing , mammography