France’s Agence Francaise De Securite Sanitaire Des Produits De Sante (AFSSAPS) banned the use of Actors, a drug prescribed to control diabetes, due to concerns that it increases the risk of bladder cancer amongst patients taking the drug. Actors manufactured by Japan’s Takeda Pharmaceutical and is one of the pharmaceutical company’s top-selling drugs. The French medical board’s decision has caused Germany to follow suit in banning the diabetes drug, with reports that the UK might soon follow.
The French drug suspension not only affects Actos, but also applies to Competact, a similar prescription drug that combines Actos with metformin. Both drugs were suspended because they contained the active ingredient Pioglitazone, which has been linked to the increase risk of bladder cancer. This risk was documented in a study of antidiabetic patients taking antidiabetic medicines that was conducted by the Caisse National d’Assurance Maladie between 2006 and 2009.
The sale of Actos was approved in Europe in 2000, with Competact being approved in 2006. Since that time, an estimated 230,000 patients use Actos in France alone. In 2010, Europe accounted for Y29.5 billion, or about 7.5%, of Actos Y387.9 billion in global sales. The banning of Actos in Europe could drastically affect the fate of the Japan-based pharmaceutical company and exposes it to potential pharmaceutical liability lawsuits.