Actos Recalled in France, U.S. Far Behind?

French health authorities have suspended Actos sales, following data that provides further evidence that users of the diabetes drug may face an increased risk of bladder cancer. The Actos recall was announced in June by AFSSAPS, the medical regulatory agency of France. The French decision to remove Actos from the market came after a review of French public insurance data found a slight increase in the risk of bladder cancer linked as a possible side effect of Actos. In France, the drug is taken by about 230,000 people. AFSSAPS said that patients should not stop taking the drug without consulting their physician, but told doctors they should no longer prescribe it.

The FDA and European Medicines Agency are both currently reviewing Actos bladder cancer risks, but neither has come to a conclusion yet. The EMA has said it will look at the French study that led to the recall there. In April, a study by Italian researchers found that more than a fifth of all bladder cancer reports received by the

FDA in connection to a diabetes drug were from users of Actos. Those findings came several months after the FDA announced that it was investigating a possible bladder cancer risk with Actos. The FDA launched an investigation in September 2010, after data from an on-going 10 year study of Actos by Takeda Pharmaceuticals suggested that users may face a statistically significant risk of bladder cancer from Actos the longer the medication is taken.

Actos was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year. The FDA approved a new label warning for Actos regarding its association with bladder cancer. The new label advises that health care professionals avoid using Actos in patients with active bladder cancer and recommends caution in patients with a prior history of bladder cancer. The new bladder cancer information will be included in the ‘Warnings and Precautions” section of the drugs’ label. Actos patients are encouraged to contact their health care provider if they notice any sign of blood in the urine, any new or worsening urinary urgency or pain during urination.