(09/06/2011)The European Medicines Agency (EMA) has been informed by the French Medicines Agency (Afssaps) of its decision to suspend the use of pioglitazone-containing medicines in France (Actos, Competact), while awaiting the outcome of the ongoing European review on the benefits and risks of these antidiabetic medicines.

 

This decision by the French authority follows receipt of results of a retrospective cohort study carried out in France which became available today. These results appear to suggest an increased risk of bladder cancer with pioglitazone.

 

The EMA’s 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 20-23 June 2011 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.

 

The Agency will make further announcements as soon as new information becomes available.

 

●编者提示：2011年6月9日，欧洲药管局发布公告称，尽管正在欧洲进行的有关这些抗糖尿病药物的益处和风险审查结果尚未出炉，但该局已收到法国药管局有关在该国停用含吡咯列酮药物的决定，原因该类药物可能引起膀胱癌风险。法国当局的这项决定是在收到了有关在该国进行的一项回顾性队列研究结果后做出的。目前国内已上市的有含吡咯列酮单成分的制剂和同时含吡咯列酮和二甲双胍的制剂。