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 Fri, 21 Sep 2012 15:15 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) On September 19, 2012, the FDA issued a Drug Safety Communication informing the public about a possible increased risk of heart failure with Mirapex, generic name pramipexole, a drug used to treat Parkinson's disease and restless legs syndrome. Fri, 21 Sep 2012 15:15 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm320476.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm320476.htm Mirapex, pramipexole, Parkinson's disease, restless legs syndrome, Drug Safety On September 13, 2012, the FDA issued a Drug Safety Communication alerting the public that certain over-the-counter, or OTC, products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied. Mon, 10 Sep 2012 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm319512.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm319512.htm topical muscle and joint pain relievers, OTC, over-the-counter, Drug Safety On August 30, 2012, the FDA issued a Drug Safety Communication recommending that Revatio, active ingredient sildenafil, not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension, or PAH. Mon, 10 Sep 2012 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm318700.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm318700.htm Revatio, children, pulmonary hypertension, Drug Safety On August 15, 2012, the FDA issued a Drug Safety Communication informing the public that FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Thu, 16 Aug 2012 14:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm315708.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm315708.htm codeine, children, tonsillectomy, adenoidectomy,Drug Safety On July 23rd, 2012, the Food and Drug Administration issued a Drug Safety Communication updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (or MS) who are starting Ampyra (dalfampridine). Tue, 24 Jul 2012 14:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm313164.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm313164.htm Ampyra, dalfampridine, multiple sclerosis, Drug Safety On June 26, 2012, the FDA issued a Drug Safety Communication reminding health care professionals about the need to adjust the dosage of the antibacterial drug cefepime in patients with renal impairment. Tue, 26 Jun 2012 03:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm309829.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm309829.htm Cefepime, Drug Safety On May 23, 2012 FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira, Inc. The pre-filled cartridges containing certain products may be overfilled by at least twice the expected amount, resulting in potential overdoses. Thu, 24 May 2012 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm305460.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm305460.htm Hospira, Drug Safety On May 14, 2012, the FDA issued a Drug Safety Communication informing the public it has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya. Tue, 15 May 2012 10:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm304140.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm304140.htm Gilenya, Drug Safety On May 7, 2012, the FDA issued a Drug Safety Communication informing the public of an increased risk of second primary malignancies in patients with newly-diagnosed multiple myeloma who received Revlimid. Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Wed, 09 May 2012 08:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm303388.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm303388.htm Revlimid, Drug Safety On April 26, 2012, the FDA issued a DSC notifying the public that co-administration of Victrelis, a hepatitis C virus, HCV, protease inhibitor, along with certain ritonavir-boosted HIV protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV viral load to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir). Mon, 30 Apr 2012 08:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm302136.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm302136.htm Victrelis, Drug Safety On April 20, 2012, the Food and Drug Administration issued a Drug Safety Communication warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (or ACE inhibitors) and angiotensin receptor blockers (or ARBs) in patients with diabetes or renal impairment. Mon, 23 Apr 2012 09:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm301269.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm301269.htm aliskiren, Drug Safety On April 8th, 2012 the FDA issued a Drug Safety Communication informing the public it has completed its review of recent epidemiologic studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Wed, 11 Apr 2012 04:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm299886.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm299886.htm drospirenone, Drug Safety On March 28, 2012, the FDA issued a Drug Safety Communication clarifying dosing and warning recommendations for the antidepressant Celexa. Fri, 30 Mar 2012 02:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm298032.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm298032.htm Celexa, Drug Safety On March 1, 2012, the Food and Drug Administration issued updated recommendations concerning drug-drug interactions between HIV or HCV drugs known as protease inhibitors and certain cholesterol-lowering drugs known as statins. Fri, 02 Mar 2012 01:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm294484.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm294484.htm Statins, Drug Safety On February 28, 2012, FDA approved important safety label changes for cholesterol-lowering statin drugs. These changes were made to provide the public with more information for the safe and effective use of statins and are based on FDA's comprehensive review of the class of drugs. Fri, 02 Mar 2012 10:52 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm294367.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm294367.htm Statins, Drug Safety On February 8, 2012, the Food and Drug Administration issued a Drug Safety Communication notifying healthcare professionals and patients that drug interactions between the hepatitis C virus, or HCV protease inhibitor Victrelis and the ritonavir-boosted HIV protease inhibitors atazanavir, lopinavir, and darunavir, can potentially reduce the effectiveness of these medicines when they are used together. Mon, 13 Feb 2012 11:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm291521.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm291521.htm Victrelis, boceprevir, hepatitis C, HIV, protease inhibitors, drug interactions, Drug Safety On February 8, 2012, the Food and Drug Administration issued a Drug Safety Communication informing the public that the use of stomach acid drugs known as PPIs may be associated with an increased risk of Clostridium difficile-associated diarrhea, also known as CDAD. Thu, 09 Feb 2012 08:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm291058.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm291058.htm Proton pump inhibitor, PPI, clostridium difficile, diarrhea, CDAD, Drug Safety On January 20, 2012, the Food and Drug Administration issued a Drug Safety Communication informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for PML. Wed, 25 Jan 2012 10:30 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm289133.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm289133.htm Progressive Multifocal Leukoencephalopathy, PML, Tysabri, natalizumab, Drug Safety On January 13, 2012, the Food and Drug Administration issued a Drug Safety Communication notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris. Tue, 17 Jan 2012 12:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm287893.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm287893.htm Adcetris,progressive multifocal leukoencephalopathy, PML, Drug Safety On January 12, 2012, the Food and Drug Administration issued a Drug Safety Communication updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 on 7/25/2011 by the manufacturer, Bracco Diagnostics, Inc. Fri, 13 Jan 2012 14:40 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm287767.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm287767.htm CardioGen, Drug Safety On December 22, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores. Fri, 23 Dec 2011 16:10 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm285058.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm285058.htm acetaminophen, OTC, Drug Safety On December 20, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public it has received a report of a patient with multiple sclerosis (or MS) who died within 24 hours of taking the first dose of Gilenya (active ingredient fingolimod). Fri, 23 Dec 2011 12:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm284994.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm284994.htm Gilenya, fingolimod, Multiple Sclerosis, MS, drug safety On December 22, the Food and Drug Administration issued a Drug Safety Communication titled: Addition of another concentration of acetaminophen marketed for infants. Thu, 22 Dec 2011 15:00 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm284611.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm284611.htm acetaminophen, OTC, Drug Safety On December 19, 2011 the Food and Drug Administration issued a Drug Safety Communication updating the public that the FDA has completed a safety review of the heart drug Multaq. Wed, 21 Dec 2011 08:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm284337.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm284337.htm Multaq, dronedarone, cardiovascular, Drug Safety On December 15, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. Fri, 16 Dec 2011 10:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283898.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283898.htm Zocor, simvastatin, amiodarone, Drug Safety On December 14, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public on the use of SSRI antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn, or PPHN. Fri, 16 Dec 2011 09:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283892.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283892.htm SSRI, Selective serotonin reuptake inhibitor, pregnancy, lung condition, Drug Safety On December 12, 2011 the Food and Drug Administration issued a Drug Safety Communication updating its communication on the ongoing cardiovascular safety review of medications used for treating ADHD, many of which are known to increase heart rate and blood pressure. Thu, 15 Dec 2011 14:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283735.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283735.htm ADHD, Attention-Deficit, Hyperactivity, cardiovascular, Drug Safety The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Fri, 09 Dec 2011 12:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283151.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm283151.htm Pradaxa, dabigatran etexilate mesylate, bleeding events, Drug Safety On December 6, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA has approved modifications to the REMS, for the platelet-booster drugs Nplate injection and Promacta tablets. The modifications include the removal of certain elements of the REMS, including the requirements for restricted distribution and additional safety data collection. Wed, 07 Dec 2011 13:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm282800.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm282800.htm Promacta, eltrombopag, Nplate, romiplostim, Risk Evaluation and Mitigation Strategy, Drug Safety The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters to firms marketing over-the-counter homeopathic HCG drug products for weight loss. These firms are violating the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act by selling unapproved and misbranded drugs that make unsubstantiated claims about weight loss. Tue, 06 Dec 2011 09:35 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm282161.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm282161.htm HCG, weight loss, Drug Safety On November 9, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that the cholesterol-lowering medicine Trilipix, active ingredient fenofibric acid, may not lower a patient's risk of having a heart attack or stroke. Thu, 10 Nov 2011 16:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm279570.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm279570.htm Trilipix, fenofibric acid, ACCORD, cholesterol, Drug Safety On November 3, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of Tumor Necrosis Factor, or TNF, blockers and malignancy in children, adolescents, and young adults (30 years of age or younger). Tue, 08 Nov 2011 14:05 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm278669.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm278669.htm TNF blockers, pediatric malignancy, Tumor Necrosis Factor, Drug Safety On November 4, 2011, the Food and Drug Administration issued a Drug Safety Communication reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 in order to continue prescribing and receiving rosiglitazone-containing medicines, such as Avandia, Avandamet, and Avandaryl. Fri, 04 Nov 2011 16:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm278686.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm278686.htm Avandia, Rosiglitazone, Avandamet, Avandaryl, Drug Safety On November 1, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public that a large, recently-completed study in children and young adults treated with medication for ADHD, has not shown an association between use of certain ADHD medications and adverse cardiovascular events. Fri, 04 Nov 2011 16:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm278391.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm278391.htm ADHD, cardiovascular, Attention-Deficit, Drug Safety On October 27, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals and the public that FDA is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone. Fri, 28 Oct 2011 08:50 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm277596.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm277596.htm Drospirenone, birth control, blood clots, Drug Safety On October 25, 2011 the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris. Tue, 25 Oct 2011 15:25 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm277212.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm277212.htm Xigris, drotrecogin alfa, withdrawal, Drug Safety On October 24, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting the public that FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix. Tue, 25 Oct 2011 09:45 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm277065.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm277065.htm Chantix, varenicline, neuropsychiatric adverse events, Drug Safety On October 20, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public on the potential drug interaction between linezolid and serotonergic psychiatric medications. Mon, 24 Oct 2011 11:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm276917.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm276917.htm linezolid, Zyvox, serotonin syndrome, psychiatric medications, Drug Safety On October 20, 2011 the Food and Drug Administration issued a Drug Safety Communication updating the public on the potential drug interaction between methylene blue and serotonergic psychiatric medications. Mon, 24 Oct 2011 11:20 EDT http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm276919.htm http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm276919.htm methylene blue, serotonin syndrome, psychiatric medications, Drug Safety 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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