Pioglitazone (Actos) Suspended in France Over Cancer Concerns

Update–June 10: Following the example of France, Germany has also suspended the use of pioglitazone. Click here for the announcement (in German).

Sales of the popular diabetes drug pioglitazone (Actos, Takeda) have been suspended in France after a study carried out by the French health insurance fund (CNAM)  found that the drug may increase the risk of bladder cancer. The French regulatory agency (AFSSAPS) said that new prescriptions for drugs containing pioglitazone may no longer be written but that people who are already taking the drug may continue to do so.

Pioglitazone is the subject of an ongoing FDA safety review for a potential increased risk of bladder cancer after 2 years of exposure. The FDA has not commented on the French action. The European Medicines Agency announced in March that it was also conducting a safety review of pioglitazone. The EMA today issued a statement about the French suspension and said that pioglitazone will be discussed at the next Committee for Medicinal Products for Human Use (CHMP) meeting on June 20-23 2011 and that it will “recommend appropriate actions as necessary” at that time. For now the EMA “is not recommending any changes to the use of pioglitazone-containing medicines.”

Here is the statement from the European Medicines Agency:

09/06/2011

Update on ongoing European review of pioglitazone–containing medicines

Suspension of use of these medicines in France while Europe-wide review continues

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.

Notes

  • The European review of the centrally authorised pioglitazone-containing medicines Actos, Glustin, Competact, Glubrava and Tandemact and the occurrence of bladder cancer is being conducted in the context of a formal review, initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, on 16 March 2011.
  • The French targeted epidemiological study is a retrospective cohort study conducted by the French health insurance (Caisse National d’Assurance Maladie) following antidiabetic patients taking antidiabetic medicines between 2006 and 2009.

Comments

  1. Due to the European Economic crisis, the suspension of this powerfull drug would only serve the interests of the government health plan, which would no longer care for the expense of this therapheutic class. That’s why European health system is not effcient, and doesn’t really care much for their people.

  2. Luciano you have a point, but that doesn’t mean that TZDs aren’t hazardous for certain diabetics. Don’t know about diabetes rates in Germany & France, but in the US it’s bad: http://bit.ly/lK4AJo

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