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.
And just as France’s Actos ban has started to catch on in other European countries, it might take effect in the U.S. as well. The U.S. Food and Drug Administration (FDA) is currently conducting its own study of the risk of developing bladder cancer among patients taking Actos. Actos is widely used among U.S. diabetic patients and was the nation’s 10th-best selling drug in 2008.
This wouldn’t be the first time Europe and the U.S. initiated a widespread ban on a diabetic medication. Avandia was a diabetic drug belonging to the same drug class as Actos. Actos was pulled from the European markets and severely restricted in the U.S. after studies linked the diabetic drug with increased heart risks. In fact, there are currently Avandia pharmaceutical liability lawsuits pending for patients who suffered heart attacks after taking Avandia.
Patients currently taking Actos should monitor the outcome of the FDA’s study and be aware of the heightened risks associated with taking Actos. Consult your doctor if you have concerns that you are at increased risk for developing bladder cancer.
Kreisman Law Offices has been handling Illinois pharmaceutical liability cases for more than 35 years in and around Chicago, Cook County, including Bridgeview, Arlington Heights, Melrose Park,, Prospect Heights, and Oak Forest.
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