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FDA Issues Safety Update for Ongoing Safety Review of Actos (Pioglitazone) and Increased Risk of Bladder Cancer
The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines, including Actos, Actoplus Met, Actoplus Met XR, and Duetact. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. This safety information is based on FDA's review of the preliminary five-year results of an ongoing 10-year study. The five-year results showed that an increased risk of bladder cancer was noted among patients who had the longest exposure to pioglitazone, and those taking the highest cumulative dose of the drug -- although pioglitazone did not lead to an increased risk of bladder cancer in the study overall. FDA recommends that healthcare professionals should: -- Not use pioglitazone in patients with active bladder cancer. -- Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence. The FDA will continue to evaluate data from the ongoing ten-year study and will also review the results from a French study, which prompted the suspension of pioglitazone products in France. The FDA will update the public when more information becomes available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm
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Thiazolidinediones Associated with Increased Risk of Fractures
A study recently published in the Canadian Medical Association Journal suggests that women taking thiazolidinediones, such as AVANDARYL, are at an increased risk of fractures of the hip and spine. Thiazolidinediones are medicines used to treat diabetes. One particular thiazolidinedione is called pioglitazone and is sold under the brand name Actos. Another is rosiglitazone, sold under the brand name Avandia. These products also come as a combination tablet with metformin (called Actoplus Met and Avandamet) and a combination tablet with glimepiride (called Avandaryl and Duetact). For more information please visit: http://www.cmaj.ca/cgi/reprint/180/1/32
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Date Published Title Drug Source
2011-06-15 FDA Issues Safety Update for Ongoing Safety Review of Actos (Pioglitazone) and Increased Risk of Bladder Cancer Glimepiride and Pioglitazone FDA
2009-09-14 Thiazolidinediones Associated with Increased Risk of Fractures Glimepiride and Rosiglitazone MediGuard CRT
2010-06-29 Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing Glimepiride and Rosiglitazone MediGuard CRT
2010-09-23 Avandia: Restricted Access Program To Be Developed Glimepiride and Rosiglitazone FDA
2011-02-04 FDA Update: Avandia, Avandamet and Avandaryl Labels Now Include Information About Heart-Related Risks, Patient Access Restrictions Expected Later This Year Glimepiride and Rosiglitazone FDA
2011-05-19 Avandia, Avandamet, and Avandaryl Soon to Be Available Only Through Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2011-11-04 FDA Reminds Healthcare Providers and Patients to Enroll in the Avandia-Rosiglitazone Medicines Access Program Glimepiride and Rosiglitazone FDA
2013-11-27 FDA Removes Some Prescribing and Dispensing Restrictions For Rosiglitazone-Containing Medicines, Including Avandia, Avandamet, and Avandaryl Glimepiride and Rosiglitazone FDA
2010-06-07 CorePharma, LLC Recalls Select Lots of Glipizide and Metformin Tablets Glipizide with Metformin FDA
2011-01-11 Novo Nordisk, Inc. A Recalls Single Lot of GlucaGen Hypokit Emergency Kit Glucagon FDA
2007-12-18 Recall of selected 5mg tablets Glyburide FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Glyburide Manufacturer
2010-06-07 CorePharma, LLC Recalls Select Lots of Glyburide and Metformin Tablets Glyburide with Metformin Hydrochloride FDA
2010-04-20 Glycopyrrolate: Corepharma LLC Issues Recall Glycopyrrolate FDA
2010-06-11 American Health Packaging and Rising Pharmaceuticals, Inc Recall Single Lot of Glycopyrrolate 2mg Tablets Glycopyrrolate FDA
2009-05-29 TNF Blockers Increase the Risk of Fungal Infections Golimumab Manufacturer
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Golimumab FDA
2011-04-25 Centocor Ortho Biotech Recalls Single Lot of Simponi (golimumab), 50 mg/0.5 mL Golimumab FDA
2008-08-05 Generic Manufacturer Recalls Several Drug Products Manufacturer
2008-10-10 Important Information About Safe Use of Children's Cough and Cold Medicine Guaifenesin Manufacturer
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