Medical News: Cancer Risk Forces Actos Off French, German Markets - in Endocrinology, Diabetes from MedPage Today
Drug regulators in Germany and France have ordered doctors to stop prescribing the type 2 diabetes drug pioglitazone (Actos) following a French study suggesting a heightened risk of bladder cancer.
But the European Medicines Agency (EMA), the FDA, and their Japanese counterpart have withheld action pending additional review of the data.
The French study, conducted by the nation's health insurance agency, examined cancer rates in some 155,000 people taking pioglitazone in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the agent.
The researchers found an adjusted hazard ratio of 1.22 (95% CI 1.05 to 1.43) for bladder cancer among those on pioglitazone.
There also appeared to be a dose effect, with a higher risk (HR 1.75, 95% CI 1.22 to 2.50) among patients receiving a cumulative dosage of 28,000 mg or more during the study period.
The study was completed on Tuesday. France's regulatory agency officially suspended sales of pioglitazone on Thursday, and Germany followed suit early Friday.
Both agencies recommended that patients currently taking the drug continue to do so until they talk to their doctors about alternative medications.