• 13
  • June
    2011

French authorities recently decided to remove Actos and Competact-a diabetes medication manufactured by Japanese pharmaceutical Takeda-from the market pending the result of a European safety review of the drugs.

Sources said the decision was made after a French study noted that the drugs were correlated with a small increase in the risk of bladder cancer among patients who had taken Competact.

While the drugs have not been completely removed from the market, regulators in both the Europe and the United States have expressed concerns. Last September the FDA announced that it was examining data from an ongoing study looking into whether Actos is connected to increased cancer risk.

The European Medicines Agency took similar steps in March when it initiated a formal investigation into the possible link after noting an increase in cancer reports among patients taking drugs containing Competact.

The Committee for Medicinal Products for Human Use(CMPH)-the committee responsible for elaborating the EMA's opinions issues regarding medicinal products for human use-is currently looking at all available data to make an assessment of the benefits and risks of the diabetes medications. The committee also said it would be looking into the results of the French study and its significance for the drug market. The Committee plans to address the issue in an upcoming meeting next week.

German officials have also recently taken steps to remove the drugs from their market until safety concerns have been addressed.

The CMPH, according to sources, recommending any alterations in patients' use of medications containing Competact.

Source: Inpharm, "France pulls Takeda diabetes drugs after cancer fears," 13 June 2011.