The French Health Products Safety Agency (Afssaps) has today decided to suspend the use of medicines containing pioglitazone (Actos and Competact), on the advice of the Committee of Authorisation Market and the National Commission Pharmacovigilance.
The decision was based on a review of preclinical, clinical, epidemiological, and pharmacovigilance data showing a potential increased risk of bladder cancer among patients with diabetes who were treated with pioglitazone.
The review included 155,535 patients aged 40 to 79 years with diabetes who were exposed to medicines containing pioglitazone and 1,335,525 patients with diabetes who were not exposed to pioglitazone-containing medicines.
The Afssaps recommends that patients currently taking medicines containing pioglitazone consult their physician to adjust their diabetes treatment.
Physicians should not prescribe more medicines containing pioglitazone.
The French Agency recommends that any serious and/or unexpected adverse events should be reported to the regional centres of pharmacovigilance.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) started a European review of pioglitazone-containing medicines in March 2011 to investigate the signal of a possible increased risk of bladder cancer with pioglitazone.
The CHMP is currently reviewing all relevant data, including data from pharmacoepidemiological studies, non-clinical and clinical data, post-marketing reports of bladder cancer, and published data to assess their impact on the balance of benefits and risks of these medicines.
The Committee will now also assess the results of the French study and its potential impact on the use of these medicines across the whole EU. The CHMP will discuss this issue at their next meeting on June 20 and recommend appropriate actions as necessary. While this review is ongoing the CHMP is not recommending any changes to the use of pioglitazone-containing medicines.
SOURCE: French Health Products Safety Agency and European Medicines Agency