Safety Alerts & Recalls

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Benefits of Bisphosphonates Continue to Outweigh Risks
A new study published in the New England Journal of Medicine provides more evidence that bisphosphonates, a class of drugs used to prevent and treat osteoporosis, are associated with atypical femur fractures. Atypical femur fractures are an unusual type of fracture in the thigh bone just below the hip joint or can occur any point over the length of the bone. The study found that these atypical fractures are rare in patients who take bisphosphonates, and that the benefits of using the bisphosphonates continue to outweigh the risks. The question of whether bisphosphonates are associated with atypical femur fractures (thigh fractures) has been closely studied in the past few years. Last October, the Food and Drug Administration (FDA) announced a change in the prescribing information to warn healthcare professionals about the possible risk of these unusual thigh fractures in patients taking bisphosphonates. Bisphosphonates, which include oral forms such as alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia), as well as injectable bisphosphonates such as zoledronic acid (Reclast) and ibandronate (Boniva), are mainly used as a way to prevent fractures that are associated with osteoporosis. For more information, please visit: http://www.nejm.org/doi/full/10.1056/NEJMoa1010650?query=TOC&
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FDA Provides Guidance for Dispensing Devices and Drugmakers Remove OTC Infant Acetaminophen Drops
The U.S. Food and Drug Administration (FDA) released final recommendations to drugmakers and distributors describing standards for dosage delivery devices such as droppers and dosage cups. These standards will help promote ease-of-use and minimize the risk of unintentional overdose from over-the-counter (OTC) liquid drug products, such as liquid pain relievers, cold medicine, cough syrups, and digestion aids. Several drugmakers have also announced they will discontinue over-the-counter (OTC) infant drops of medicines containing acetaminophen in an effort to avoid confusion that can lead to dangerous overdoses. Acetaminophen is a key ingredient in Tylenol, Nyquil, and many other OTC medicines sold to combat pain and fever. Right now, the infant formulations on store shelves contain half of the amount of acetaminophen that is found in regular children’s formula. Parents can accidentally give infants too much of the ingredient if they do not read the instructions carefully or use the dropper with a different formulation of the drug. The phase out is expected to begin later this year. At that time, the OTC makers will only sell a single concentration for all children under the age of 12, which will contain 160 milligrams per 5 milliliters. For more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm254029.htm and http://www.chpa-info.org/05_05_11_PedAceConv.aspx
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Date Published Title Drug Source
2011-05-06 Benefits of Bisphosphonates Continue to Outweigh Risks Ibandronate Sodium MediGuard CRT
2011-05-06 FDA Provides Guidance for Dispensing Devices and Drugmakers Remove OTC Infant Acetaminophen Drops FDA
2011-05-11 Multi-Mex Distributor Inc. Announces Recall of Dietary Supplements Amoxicillin FDA
2011-05-19 Avandia, Avandamet, and Avandaryl Soon to Be Available Only Through Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2011-05-20 Teva Pharmaceuticals Recalls Several Lots of Simvastatin Tablets USP, 20 mg and 80 mg Simvastatin FDA
2011-05-20 Teva Pharmaceuticals Recalls Single Lot of Metformin Hydrochloride Tablets, USP 500 mg Metformin FDA
2011-05-20 Novartis Pharmaceuticals Corp. Recalls Single Lot of Valturna (aliskiren and valsartan) Tablets 300 mg/320 mg Aliskiren and Valsartan FDA
2011-05-20 Coloplast Manufacturing US Recalls Select Lots of Critic-Aid Skin Paste 2.5 oz/71g Petrolatum and Zinc Oxide FDA
2011-05-26 Pfizer Pharmaceuticals LLC. Recalls Single Lot of Aldactone (spironoloactone) tablets USP 50 mg Spironolactone FDA
2011-05-26 Regrowth LLC Recalls Several Lots of Retinoic Acid, Minoxidil, and Spironolactone Topical Solution Tretinoin FDA
2011-05-26 FDA Issues Statement on the AIM-HIGH Trial Niacin FDA
2011-05-26 FDA Conducting a Safety Review of Revlimid and Risk of Developing Another Primary Cancer Lenalidomide FDA
2011-05-27 Teva Pharmaceuticals USA. Recalls Single Lot of Fexofenadine Hydrochloride Tablets USP, 180 mg Fexofenadine FDA
2011-05-31 FDA to review studies showing higher blood clot risk from drospirenone Drospirenone with Ethinyl Estradiol FDA
2011-06-01 Pentrexyl Forte Natural Recalled Due to Misleading Packaging Ampicillin FDA
2011-06-01 Teva Pharmaceuticals USA Recalls Single Lot of Nabumetone Tablets USP, 750 mg Nabumetone FDA
2011-06-01 Teva Pharmaceuticals Recalls Single Lot of Lansoprazole Delayed-Release Capsules USP, 30 mg Lansoprazole FDA
2011-06-01 Sandoz Inc. Recalls Single Lot of Metformin Hydrochloride Tablets 1000 mg Metformin FDA
2011-06-02 FDA Completes Safety Review: Angiotensin Receptor Blockers (ARBs) for High Blood Pressure Do Not Increase Risk of Cancer Telmisartan FDA
2011-06-06 Lupin Pharmaceuticals Inc. Recalls Several Lots of Perindopril 2 mg Tablets Perindopril FDA