As of November 18, 2011, the diabetes drugs containing rosiglitazone (Avandia, Avandamet and Avandaryl) will only be available by mail order through specially certified pharmacies enrolled in the Avandia-Rosiglitazone Medicines Access Program sponsored by the Food and Drug Administration (FDA). The FDA had issued a reminder on November 4th to all healthcare providers and patients to enroll in the program by November 17th if they wished to continue to prescribe or receive rosiglitazone medicines.
The Medicines Access Program was necessitated by the FDA’s concern to limit the number of people exposed to the potential heart side effects found to exist with Avandia. It has been estimated by experts that as many as 100,000 heart attacks may have been caused by Avandia. The drug is currently the subject of thousands of lawsuits against GlaxoSmithKline, the pharmaceutical company that markets the drug. While GSK has agreed to settlements on many of these suits, there are still thousands of injury cases related to Avandia still being litigated in courts throughout the United States.
Because of the heart related problems with Avandia, Actos (pioglitazone) has become a popular alternative treatment option for those individuals dealing with type 2 diabetes. Actos already was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion.
Actos has now been determined to carry with it a high risk of bladder cancer. The French Agency for the Safety of Health Products decided on June 9, 2011 to withdraw pioglitazone due to the risk. On June 10, 2011 Germany’s Federal Institute for Drugs and Medical Devices advised doctors not to prescribe the medication until further investigation into the cancer risks could be conducted. The U.S. FDA announced on June 15, 2011 that pioglitazone use for more than one year may be associated with an increased risk of bladder cancer. Information about this risk was to be added to the Warnings and Precautions section of the label of any pioglitazone containing medicines. The FDA had released an early communication in September 2009 that interim data from an on-going 10 year study of Actos users indicated that they may have an increase in the incidents of bladder cancer. Actos cancer warnings were approved by the FDA in August 2011.
Lawsuits have been filed throughout the United States against the drug’s manufacturer Takeda Pharmaceuticals, alleging failure to provide adequate warnings about the risk of bladder cancer and/or that Takeda should have recalled Actos from the market because the risks of bladder cancer outweigh the minimal benefits the drug offers.
The Padberg Corrigan Law Firm has extensive experience in medical and pharmaceutical related inuries. If you feel that you or a loved one has been injured by the drugs Avandia, Avandament, Avandaryl or Actos, please contact us for a free evaluation of your case.