Actos pioglitazone regulatory update

FDA is updating the label of diabetes drug Actos pioglitazone from Takeda to warn that use of the drug for >1 year may be associated with an increased risk of bladder cancer. Takeda said in a statement it is working with FDA to update the label and with regulatory agencies in Europe to evaluate the drug's safety. Earlier this month, the French Medicines Agency suspended and the German Institute for Drugs and Medical Devices (BfArM) recommended against the use of Actos based on the results from a French retrospective study (see BioCentury, June 13). EMA's CHMP is scheduled to discuss Actos at its June 20-23 meeting ...