Safety Alerts & Recalls

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Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing
Two major studies have found the medicine Avandia (rosiglitazone) could increase the risk of having a heart attack and other serious problems including strokes, heart failure, and death. These studies were published this week in the medical journals Archives of Internal Medicine and the Journal of the American Medical Association (JAMA). The FDA has been conducting an ongoing safety review of Avandia and the risks of heart attack, stroke, and heart failure for several months. No new conclusions or recommendations about the use of Avandia in the treatment of type 2 diabetes have been made at this time. An FDA advisory committee of experts will meet in July 2010 and review these new studies plus others. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of Avandia in the treatment of type 2 diabetes. For more information, please visit: http://archinte.ama-assn.org/cgi/content/full/2010.207 and http://jama.ama-assn.org/cgi/content/full/jama.2010.920
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P&G Recall: 4-Hour Nasal Decongestant Spray by Sinex Sold in U.S. Stores
The Procter & Gamble Company (P&G) is voluntarily recalling its 4-Hour decongestant nasal spray. The product was distributed nationwide in the United States. The company said it is taking this voluntary precautionary step after finding that the product formulation may not meet the expiration dates on the package. This recall is not a result of consumer complaints. The recall includes these nasal sprays with an expiration date prior to June 2013: VapoSpray 4-Hour Nasal Spray by Sinex (UPC code: 3 23900 00082 7) Sinex Nasal Spray (sold prior to June 2009): spray (UPC code: 3 23900 00082 7) and ultra-fine mist (UPC code: 3 23900 00085 8) To view photos of the recalled product and read the press release, please visit: http://multivu.prnewswire.com/mnr/pg/44953/
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Date Published Title Drug Source
2010-06-29 Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing Glimepiride and Rosiglitazone MediGuard CRT
2010-06-25 P&G Recall: 4-Hour Nasal Decongestant Spray by Sinex Sold in U.S. Stores Oxymetazoline Manufacturer
2010-06-22 FDA: Pfizer Voluntarily Withdraws Mylotarg (gemtuzumab ozogamicin) From U.S. Market FDA
2010-06-18 Long-term Use of Isotretinoin Linked to Increased Risk of Ulcerative Colitis Isotretinoin MediGuard CRT
2010-06-18 FDA Warns That Generic Tamiflu From Internet Is Fake and Could Be Harmful Oseltamivir FDA
2010-06-16 McNeil Expands Recall To Include Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels Diphenhydramine Manufacturer
2010-06-15 FDA Warns Consumers About Correct Vitamin D Supplementation for Infants Ergocalciferol FDA
2010-06-14 Angiotensin-Receptor Blockers (ARBs) May Be Linked to Small Increased Risk of Cancer Telmisartan MediGuard CRT
2010-06-11 UCB Manufacturing, Inc and DSM Pharmaceuticals, Inc Recall Two Lots of Semprex-D Capsules Acrivastine and Pseudoephedrine FDA
2010-06-11 King Pharmaceuticals Inc, and Actavis Elizabeth LLC Recall Several Lots of Embeda Morphine and Naltrexone FDA
2010-06-11 Additional List of Recalled Lots of Daytrana Patches Published By FDA Methylphenidate FDA
2010-06-11 American Health Packaging and Rising Pharmaceuticals, Inc Recall Single Lot of Glycopyrrolate 2mg Tablets Glycopyrrolate 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
2010-06-07 Recall of Several Lots of Acetasol HC and Hydrocortisone and Acetic Acid Ear Products FDA
2010-06-07 Generic Manufacturer Recalls Two Lots of Spironolactone 25 mg Tablets Spironolactone FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glyburide and Metformin Tablets Glyburide with Metformin Hydrochloride FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glipizide and Metformin Tablets Glipizide with Metformin FDA
2010-06-03 Updated Prescribing Information Now Available for Inhalers Used for Asthma: Serevent, Foradil, Brovana, and Others Arformoterol FDA
2010-06-01 All Lots of Four Select PediaCare Products Recalled Dextromethorphan Manufacturer
2010-06-01 All Lots of Four Select PediaCare Products Recalled Manufacturer
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