The French medicines agency (AFSSPS) has suspended the use of the diabetes drug Actos until a European safety review has been conducted. Actos is manufactured by Takeda Pharmaceuticals and the current estimated patient population taking the drug in France is 230,000. The AFSSPS made the decision to withdraw Actos after a French study found that the drug resulted in a small increase in the risk of bladder cancer.
German authorities have made a similar decision and suspended the use of Actos as well. The drug, however, has not been withdrawn from the market even though regulators in the Europe and the United States also have concerns over its use. The European Union's drug safety regulators are reviewing the data from the French study as well as non-clinical and clinical data, post-marketing reports of bladder cancer, and pharmacoepidemiological studies, in order to better asses Actos' risks.
Actos is a drug that contains Pioglitazone, which is used to treat type 2 diabetes. Pioglitazone works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. In 2010, Actos had annual sales of $4.83 billion and is Takeda's leading product.
While French regulators have said that doctors should stop prescribing Actos, the AFSSPS has also stated that those patients who are still taking the Actos should check with their doctor first before stopping taking the drug.