The French Medicines Agency (Afssaps) has informed the European Medicines Agency (EMA) of the suspension of the pioglitazone-containing antidiabetic medicines Actos and Competact in France pending the outcome of the European risk–benefit review.
Results from a French retrospective cohort study released earlier this month appear to suggest an increase in the risk of bladder cancer with the use of pioglitazone, which has influenced the decision of the ban by Afssaps.
The European review of pioglitazone-containing medicines was initiated by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in March 2011, to investigate the possible risk of increased bladder cancer with the use of these medicines.
The CHMP risk–benefit review includes assessment of clinical and non-clinical data, pharmacoepidemiological studies, post-marketing reports of bladder cancer, and now also the results of the French retrospective cohort study.
Recommendations will be discussed at the next CHMP meeting in mid June, but meanwhile CHMP are not recommending any changes in the use of pioglitazone-containing medicines.