Actos, Competact Removed From French Pharmacies

Takeda Pharmaceutical Company announced that its subsidiary, Laboratoires Takeda, is withdrawing the medications Actos and Competact from France at the request of the French health regulatory authority AFSSAPS.

The decision to suspend the two products came after research found that pioglitazone-containing products may increase the risk of bladder cancer in some patients treated with the drugs on a long term basis. As a result, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) began a review of pioglitazone in March 2011 with the full cooperation of Takeda.

The review is ongoing and the CHMP is scheduled to discuss the benefits and risks of the medications at its next meeting this month before releasing an opinion on the case. As of now, the EMA has not recommended any changes to the labels of either Actos or Competact and has not recommended that the medications be removed in other European Union nations.

Pioglitazone medications are used to treat type 2 diabetes. In a statement, Takeda said it is, “confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes.”

Last month, the U.S. Food and Drug Administration issued a warning to consumers about the bladder cancer risks associated with pioglitazone. However, the medication can still be legally prescribed in the U.S. In May, the diabetes medication Avandia – a member of a class of drugs called thiazolidinediones, like Actos – was pulled from U.S. shelves after it was linked to an increased risk of heart attacks.

Actos has also been linked to other ailments. Another study found that both Actos and Avandia were connected to a higher risk for the eye disease diabetic macular edema, which could lead to blindness. The study was presented at the annual meeting of the American Diabetes Association.