Safety Alerts & Recalls

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New FDA Labeling for OTC Pain Relievers Also Applies to Patients Taking Combination Products
The Food and Drug Administration announced it will require manufacturers of over-the-counter (OTC) pain relievers, fever reducers and other cough and cold medication that contain aspirin (the active ingredient in Bayer Aspirin and many other brands) to revise their labeling to include warnings about potential safety risks, such as internal bleeding, associated with the use of these popular drugs. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm153331.htm
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Recombinant Human Growth Hormone (Somatropin): FDA Conducting Ongoing Safety Review
The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France found that persons with certain kinds of short stature treated with recombinant human growth hormone (somatropin) during childhood and who were followed over a long period of time, were at a small increased risk of death when compared to individuals in the general population of France. This study, the Sante Adulte GH Enfant (SAGhE) study, involved patients who had idiopathic growth hormone deficiency and idiopathic or gestational short stature. The FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review. Recombinant human growth hormone is a protein that is manufactured to be nearly identical to the main form of the naturally occurring human growth hormone. This hormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism. It has approved indications in both the adult and pediatric populations. Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, is marketed under the following brand names in the United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm237773.htm
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Date Published Title Drug Source
2009-05-04 New FDA Labeling for OTC Pain Relievers Also Applies to Patients Taking Combination Products Soma Compound with Codeine FDA
2010-12-24 Recombinant Human Growth Hormone (Somatropin): FDA Conducting Ongoing Safety Review Somatropin FDA
2011-08-05 FDA Updates Safety Review For Recombinant Human Growth Hormone (Somatropin) Somatropin FDA
2010-06-07 Generic Manufacturer Recalls Two Lots of Spironolactone 25 mg Tablets Spironolactone FDA
2011-05-26 Pfizer Pharmaceuticals LLC. Recalls Single Lot of Aldactone (spironoloactone) tablets USP 50 mg Spironolactone FDA
2009-06-18 Nationwide Recall of Stamina-Rx Dietary Supplement FDA
2009-02-05 Recall on Ther-Rx Brand Iron Supplements Manufacturer
2010-07-20 Recall of Two Lots of Sulfacetamide Sodium Topical Suspension Sulfacetamide FDA
2010-11-04 Blenheim Pharmacal Recalls Sulfamethoxazole and Trimethoprim DS Tablets Sulfamethoxazole with Trimethoprim FDA
2008-07-14 Not recommended for combination use Sunitinib Manufacturer
2013-01-14 Mylan Pharmaceuticals Inc. Recalls Several Lots of Tacrolimus Capsules 0.5 mg Tacrolimus FDA
2008-11-10 Postmenopausal Hormone Therapy May Be Associated with Heartburn Tamoxifen MediGuard CRT
2009-01-05 Important Information About Tamoxifen Tamoxifen MediGuard CRT
2009-06-01 Select Antidepressants May Interact with Tamoxifen (Novaldex) Tamoxifen MediGuard CRT
2010-11-29 Vintage and Qualitest Pharmaceuticals Recall a Single Lot of Prednisone Tamoxifen FDA
2010-11-29 Teva Recalls Single Lot of Tamoxifen Tamoxifen FDA
2009-08-27 Tamsulosin (Flomax) Linked to Serious Eye Complications Following Cataract Surgery Tamsulosin MediGuard CRT
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2012-12-19 FDA Warns That Hepatitis C Drug Incivek Can Cause Potentially Fatal Skin Reactions Telaprevir FDA
2010-06-14 Angiotensin-Receptor Blockers (ARBs) May Be Linked to Small Increased Risk of Cancer Telmisartan MediGuard CRT
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