Safety Alerts & Recalls

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FDA Issues Statement on the AIM-HIGH Trial
The National Institutes of Health (NIH) has announced that it has stopped the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) study. The AIM-HIGH study tested whether adding various drugs to statins would increase high-density lipoprotein (HDL) or "good" cholesterol enough to protect the heart. One of medicines tested was Niaspan, an extended-release form of the B-vitamin niacin that is a higher dose than is usually found in dietary supplements. The AIM-HIGH study was stopped because people taking high doses of niacin saw no benefit. In response to the NIH announcement, the Food and Drug Administration (FDA) stated it will conduct a full review of the results from AIM-HIGH once they are available. The Agency will update the public with any new recommendations or conclusions when its review of the AIM-HIGH trial data is complete. High-dose niacin is a prescription drug that is used along with diet and exercise to manage cholesterol and fat (triglyceride) levels in the blood. It is also indicated as a single treatment to lower the risk of heart attacks in patients who have had a heart attack and have high cholesterol. High-dose niacin is available as an extended-release tablet under the brand-name Niaspan, and is also available in combination with simvastatin under the brand-name Simcor, and in combination with lovastatin under the brand-name Advicor. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm
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Regrowth LLC Recalls Several Lots of Retinoic Acid, Minoxidil, and Spironolactone Topical Solution
Regrowth LLC. has recalled several of its products including: Retinoic Acid 0.025% (containing 0.025% Retin-A) Topical solution, 60 mL bottle Retinoic Acid 0.05% (Containing 0.05% Retin-A) Topical solution, 60 mL bottle 2% Spironolactone Topical Solution, 60 mL bottle, 5% Spironolactone Lotion, 2 oz jar Treatment Shampoo (2% Ketoconazole and 3% Salicylic Acid) Topical Solution, 4 oz bottle Minoxidil 5% Topical Solution, 65 ml bottle Minoxidil 5% with 0.025% Retinoic Acid Topical Solution, 65 mL bottle Minoxidil 5% Topical Solution without Propylene Glycol, 65 mL bottle Xandrox (5% Topical Minoxidil Azelaic Acid Solution), Day Time Formulation, 65 ml bottle Xandrox Solution, Nigh Time formulation, 65 ml bottle Xandrox without Propylene Glycol Solution, 65 ml bottle, 12.5% Minoxidil Solution, 125 mL bottle 6% Minoxidil Plus Solution, 65 ml bottle Xandrox Medicated Lotion (12.5% Minoxidil and 5% Azelaic Acid), 30 mL and 125 mL bottle Xandrox 15 (15% Minoxidil and 5% Azelaic Acid) Solution, 125 mL bottle Xandrox 15-Plus (15% Minoxidil, 5% Azelaic Acid and 0.1% Finasteride) Solution, 125 mL bottle All lots of these products from Regrowth LLC are being recalled because the manufacturer of these products did not submit these products to be approved by the Food and Drug Administration and these products may present potential health hazards. These recalled products are used to treat a variety of skin problems, including acne and hair loss. This recall alert only applies to the skin products made by Regrowth LLC. No other retinoic acid, minoxidil, or spironolactone products are involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm256794.htm
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Date Published Title Drug Source
2011-05-26 FDA Issues Statement on the AIM-HIGH Trial Niacin FDA
2011-05-26 Regrowth LLC Recalls Several Lots of Retinoic Acid, Minoxidil, and Spironolactone Topical Solution Tretinoin FDA
2011-05-26 Pfizer Pharmaceuticals LLC. Recalls Single Lot of Aldactone (spironoloactone) tablets USP 50 mg Spironolactone FDA
2011-05-20 Coloplast Manufacturing US Recalls Select Lots of Critic-Aid Skin Paste 2.5 oz/71g Petrolatum and Zinc Oxide FDA
2011-05-20 Novartis Pharmaceuticals Corp. Recalls Single Lot of Valturna (aliskiren and valsartan) Tablets 300 mg/320 mg Aliskiren and Valsartan FDA
2011-05-20 Teva Pharmaceuticals Recalls Single Lot of Metformin Hydrochloride Tablets, USP 500 mg Metformin FDA
2011-05-20 Teva Pharmaceuticals Recalls Several Lots of Simvastatin Tablets USP, 20 mg and 80 mg Simvastatin FDA
2011-05-19 Avandia, Avandamet, and Avandaryl Soon to Be Available Only Through Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2011-05-11 Multi-Mex Distributor Inc. Announces Recall of Dietary Supplements Amoxicillin FDA
2011-05-06 FDA Provides Guidance for Dispensing Devices and Drugmakers Remove OTC Infant Acetaminophen Drops FDA
2011-05-06 Benefits of Bisphosphonates Continue to Outweigh Risks Ibandronate Sodium MediGuard CRT
2011-05-02 Bristol-Myers Squibb Recalls Coumadin 5 mg Tablets Warfarin Manufacturer
2011-05-02 Novartis Pharmaceuticals Recalls Single Lot of Foradil Aerolizer (formoterol fumerate inhalation powder), 12 mcg Formoterol FDA
2011-05-02 Aurobindo Pharmaceuticals Recalls Several Lots of Mirtazapine Tablets, 45 mg Mirtazapine FDA
2011-05-02 Abbott Laboratories Recalls Select Lots of Humira (adalimumab) Pen, 40 mg/0.8mL Adalimumab FDA
2011-05-02 UDL Laboratories, Inc. Recalls Single Lot of Levothyroxine Sodium Tablets, 150 mcg Levothyroxine FDA
2011-05-02 Teva Recalls Single Lot of Chlorzoxazone Tablets, 500 mg Chlorzoxazone FDA
2011-04-29 FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and the Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2011-04-29 New Study: Too High a Dose of Thyroid Drug Raises Fracture Risk in Older Adults Levothyroxine MediGuard CRT
2011-04-26 More Research Needed to Confirm Recent Study Results Showing That Anti-inflammatory Pain Medicines May Dampen Effect of Selective Serotonin Re-uptake Inhibitors (SSRIs) Paroxetine MediGuard CRT