Takeda Withdraws Pioglitazone-containing Products from French Market

The decision to suspend the two products was taken on the basis of a small increased risk of bladder cancer in patients treated with pioglitazone observed in a French database study.

Laboratoires Takeda in France is withdrawing pioglitazone-containing products Actos and Competact in the country, at the request of AFSSAPS, the French health regulatory authority.

Laboratoires Takeda is working with French regulatory authorities to implement the withdrawal. The decision to suspend the two products was taken on the basis of a small increased risk of bladder cancer in patients treated with pioglitazone observed in a French database study (CNAMTS) independently conducted by French authorities.

A pan-European review of pioglitazone (an “Article 20 Referral Procedure”) started in March 2011 and Takeda is fully cooperating with the EMA in the Article 20 review. Takeda was notified on June 23, 2011 (European time) that, the review of pi