Recent activity by the United States Food & Drug Administration (FDA), as well as its European counter-part, the European Medicines Agency (EMA), has both doctors and users of the Type 2 Diabetes drug Actos (Pioglitazone) severely concerned.
As of June 10, 2011 the drug Actos has been removed from shelves in France and German doctors have been instructed not to prescribe Actos to their patients. These efforts come in response to recent studies that show an increased rate in bladder cancer among users who have undergone treatment for their Type 2 Diabetes using Actos.
Although the occurrence of such cancers in animal test subjects during pre-market studies was well know to regulatory agencies and the manufacturer, Takeda, Inc., the drug Actos, as well various combination therapy regiments that incorporate Actos, have been used to treat Type 2 Diabetes since 2000. More than 2.3 million prescriptions for the drug were issued in the United States in 2010, and Actos been considered one of the top selling drugs in the American marketplace. The active ingredient in Actos, Pioglitazone, is also used in ActoPlus met, ActoPlus met XR and Duetac to treat Type 2 Diabetes.
On June 15, 2011, in a move less drastic then that of the European regulatory agencies, the FDA issued an urgent health warning to users and prescribers of the drug Actos acknowledging the recent statistical data that shows up to a 40% increase in risk for bladder cancer in users of Actos. The studies further show that the risk of bladder cancer increases with higher dosages and longer courses of treatment with Actos.
The FDA will now require that these recent findings and risks be included in warnings attached to the drug packaging and future marketing materials. Invoking a wait and see approach, the FDA has insisted that it will continue to monitor the data being released by various ongoing studies into the long term health effects of Actos (Pioglitazone). In the meantime, Actos remains available to consumers in the United States despite these newly found risks.