On June 10, 2001 the French Medicines Agency (Afssaps) suspended the sales of Takeda’s diabetes drugs Actos (pioglitazone) and Competact because of fears of an association with bladder cancer. The French made the call after receiving new data from a retrospective cohort study carried out in the country which appears to indicate a slight increased risk of bladder cancer with pioglitazone-containing medicines. Following the French move, German authorities have now informed Takeda that they will take the same measures.
The European Medicines Agency (EMA) is currently investigating the safety of pioglitazone and is looking into a potential link with bladder cancer in patients with diabetes to clarify the drug’s benefit-risk profile. In September 2010, the U.S. Food and Drug Administration began a review of Actos after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of the $4 billion-a-year drug. Those findings are based on five-year data from an ongoing, ten-year observational study being carried out by the Japanese firm’s North Amercian division.
The glitazone class of diabetes drugs has been associated with severe adverse risks. Rezulin was pulled from the market because of the risk of the liver; Avandia has been pulled from the market because of the risk of heart attacks and now Actos may be pulled in many markets for an association with bladder cancer. Rezulin and Avandia resulted in much product liability litigation. If you need more information on this matter, you can contact Frank Woodson, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
Source: Pharma Times Online
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