Safety Alerts & Recalls

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FDA Announces Ongoing Safety Review of Gonadotropin-Releasing Hormone (GnRH) Agonists
The U.S. Food and Drug Administration (FDA) is evaluating whether Gonadotropin-Releasing Hormone (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. The agency is reviewing data from published studies comparing outcomes in men receiving GnRH agonists to treat prostate cancer versus men not undergoing this treatment. At this time, it is unknown whether these same findings apply to women receiving GnRH agonists. GnRH agonists are drugs that lower male hormones, which has the effect of shrinking prostate tumors or slowing the growth of prostate cancer. GnRH agonists are also used by women in the management of endometriosis. GnRH agonists include leuprolide (Eligard, Lupron, Viadur), goserelin (Zoladex), triptorelin (Trelstar), histrelin (Supprelin, Vantas), and nafarelin (Synarel). At this time, FDA has not concluded that receiving GnRH agonists increases the risk of diabetes and certain cardiovascular diseases. The FDA will continue to review information relating to this safety concern and notify the public as more information becomes available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209842.htm To view a detailed list of FDA approved GnRH agonists, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209842.htm#table
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Medication Guide Reviews Risks of Vivitrol
Today, Alkermes and the FDA notified healthcare professionals and patients about the availability of a new patient Medication Guide for Vivitrol. The Vivitrol Medication Guide describes the risk of injection site reactions from Vivitrol as well as other important information about treatment with Vivitrol, including side effects, who should not take Vivitrol, what patients should tell their healthcare professional before starting Vivitrol, and what they should avoid while taking Vivitrol. To view a copy of the Vivitrol Medication Guide, please visit: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206669.pdf For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210755.htm
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Date Published Title Drug Source
2010-05-03 FDA Announces Ongoing Safety Review of Gonadotropin-Releasing Hormone (GnRH) Agonists Lupron FDA
2010-05-04 Medication Guide Reviews Risks of Vivitrol Naltrexone Manufacturer
2010-05-06 What Consumers Need to Know About Recalled Liquid Products for Children Cetirizine Manufacturer
2010-05-10 Voluntary Recall of Certain Lots of Claritin Eye Drops Ketotifen Manufacturer
2010-05-12 Proton Pump Inhibitors (PPIs) May Be Linked to Bone Fractures and Bacterial Infections Omeprazole MediGuard CRT
2010-05-12 Diflorasone Cream: Nycomed Recalls Two Lots Diflorasone FDA
2010-05-12 Nycomed Recalls Several Different Eye Ointments Maxitrol FDA
2010-05-12 Serious Side Effects from Swallowing Topical Benadryl Product Diphenhydramine FDA
2010-05-25 Ultram and Ultracet Prescribing Information Updated Tramadol FDA
2010-05-26 FDA Updates Prescribing Information for Proton Pump Inhibitors to Warn About Increased Risk of Fractures Dexlansoprazole FDA
2010-05-27 FDA Completes Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury Orlistat FDA
2010-06-01 All Lots of Four Select PediaCare Products Recalled Manufacturer
2010-06-01 All Lots of Four Select PediaCare Products Recalled Dextromethorphan Manufacturer
2010-06-03 Updated Prescribing Information Now Available for Inhalers Used for Asthma: Serevent, Foradil, Brovana, and Others Arformoterol FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glipizide and Metformin Tablets Glipizide with Metformin FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glyburide and Metformin Tablets Glyburide with Metformin Hydrochloride FDA
2010-06-07 Generic Manufacturer Recalls Two Lots of Spironolactone 25 mg Tablets Spironolactone FDA
2010-06-07 Recall of Several Lots of Acetasol HC and Hydrocortisone and Acetic Acid Ear Products FDA
2010-06-11 The U.S. Food and Drug Administration (FDA) Announces Ongoing Safety Review of Benicar and Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2010-06-11 American Health Packaging and Rising Pharmaceuticals, Inc Recall Single Lot of Glycopyrrolate 2mg Tablets Glycopyrrolate FDA