Safety Alerts & Recalls

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GlaxoSmithKline Recalls All Lots of DynaCirc CR (Isradipine) Tablets
GlaxoSmithKline has issued a recall of all bottles of DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg and 10 remaining in the U.S. market due to the potential for tablet mix-ups at a Novartis plant that supplies and packages the drug. Glaxo has received no reports of adverse events or any complaints of foreign products or tablet mixups in any of the bottles of DynaCirc CR. However, Glaxo is issuing the recall as a precaution after receiving information about an inconsistent packaging process that may have resulted in a tablet mix-up for products packaged at the Novartis plant. Due the recall, DynaCirc will not be available to patients. Glaxo cannot predict when the supply of DynaCirc will resume. DynCirc contains isradipine and is a treatment for high-blood pressure. Other treatments for high blood pressure are available. For more information, please visit: http://online.wsj.com/article/BT-CO-20120224-715090.html and http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm293085.htm
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New Study Suggests Sleeping Pills May Raise Risk of Death
Several high-profile newspapers and news agencies have recently reported on a new study that suggests that sleeping pills are linked to an increased risk of death. Published in the British Medical Journal (BMJ), this study examined eight different types of sleeping pills separately: zolpidem (Ambien), temazepam (Restoril), eszopiclone (Lunesta), zaleplon (Sonata), triazolam (Halcion), flurazepam, barbiturates and antihistamines. Each of these sleeping medicines was associated with an increased risk of death. For those patients prescribed high doses, cancer incidence also increased. Although a positive association was found, this study alone cannot tell us that the medicines themselves are the direct cause of higher rates of death and cancer. This is because the increased risk could be due to other factors outside of the medicines, such as lifestyle issues, alcohol use, or smoking. This study does raise important questions that require further research to answer. For more information, please visit: http://bmjopen.bmj.com/content/2/1/e000850.full
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Date Published Title Drug Source
2012-02-29 GlaxoSmithKline Recalls All Lots of DynaCirc CR (Isradipine) Tablets Isradipine Manufacturer
2012-02-29 New Study Suggests Sleeping Pills May Raise Risk of Death Eszopiclone MediGuard CRT
2012-02-28 FDA Revises Dose Limitations for Lovastatin (Mevacor) and Lovastatin/Niacin (Advicor) Lovastatin FDA
2012-02-28 FDA Provides Safety Advice for Statins Atorvastatin FDA
2012-02-27 Glenmark Generics Recalls Birth Control Pills Due To Packaging Error that May Increase Risk of Unintended Pregnancies Ethinylestradiol with Norgestimate FDA
2012-02-26 FDA Issues Consumer Update about Grapefruit Juice and Medicine Interactions Cyclosporine FDA
2012-02-22 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Manufacturer
2012-02-22 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Acetaminophen Manufacturer
2012-02-19 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Manufacturer
2012-02-17 Healthcare Professionals Advised That a Single Batch Of Clexane Syringe Needle Caps May Be Difficult To Remove Lovenox MHRA
2012-02-16 FDA Says Midodrine Will Continue to Be Available While Additional Studies Are Conducted Midodrine Hydrochloride FDA
2012-02-16 FDA and Manufacturers Warn about Conterfeit Avastin (Bevacizumab) Bevacizumab FDA
2012-02-13 FDA Issues Warning about Important Drug Interactions Between Victrelis (boceprevir) and Ritonavir-boosted Human Immunodeficiency Virus (HIV) Protease Inhibitors Lopinavir with Ritonavir FDA
2012-02-08 FDA Issues Safety Announcement: Proton Pump Inhibitors (PPIs) Possibly Associated with Clostridium Difficile-Associated Diarrhea (CDAD) Dexlansoprazole FDA
2012-02-02 Teva Pharmaceuticals USA, Inc Recalls Select Lots of Tetracycline Capsules 500 mg Tetracycline FDA
2012-02-02 Sanofi-aventis US, Inc. Recalls Several Lots of Lantus Insulin Glargine FDA
2012-02-02 Glenmark Generics Inc. Recalls Single Lot of Glenmark Clotrimazole Cream Clotrimazole FDA
2012-02-02 Paddock Laboratories, Inc. Recalls Select Lots of Ciclopirox Gel 0.77% Ciclopirox FDA
2012-02-02 Warner Chilcott Company Recalls Several Lots of Ovcon 50 Tablets Norethindrone with Ethinyl Estradiol FDA
2012-02-02 Taro Pharmaceuticals USA, Inc. Recalls Several Lots of Fluocinonide, Ointment USP, 0.05% Fluocinonide FDA