June 9th, 2011
Pioglitazone (Actos) Suspended in France Over Cancer Concerns
Sales of the popular diabetes drug pioglitazone (Actos, Takeda) have been suspended in France after a study carried out by the French health insurance fund (CNAM) found that it may increase the risk of bladder cancer. The French regulatory agency (AFSSAPS) said that new prescriptions for drugs containing pioglitazone may no longer be written, but that people who are already taking the drug may continue to do so.
Pioglitazone is the subject of an ongoing FDA safety review for a potential increased risk of bladder cancer after 2 years of exposure. The FDA has not commented on the French action. The European Medicines Agency (EMA) announced in March that it was also conducting a safety review of pioglitazone. The EMA today issued a statement about the French suspension and said that pioglitazone will be discussed at the next Committee for Medicinal Products for Human Use (CHMP) meeting on June 20-23, 2011, and that it will “recommend appropriate actions as necessary” at that time. For now, the EMA “is not recommending any changes to the use of pioglitazone-containing medicines.”