ARTICLE | Clinical News

Actos pioglitazone endocrine data

July 4, 2011 7:00 AM UTC

Last month, the French Medicines Agency suspended and the German Institute for Drugs and Medical Devices (BfArM) recommended against the use Actos after a French retrospective study showed an increased risk of bladder cancer associated with the diabetes drug. Meanwhile, FDA said it is updating Actos' label to warn that use of the drug for >1 year may be associated with an increased risk of bladder cancer (see BioCentury, June 13). Last year, EMA suspended the only other drug in the TZD PPAR gamma agonist class - Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.) - based on cardiovascular safety concerns. FDA also significantly restricted Avandia in the U.S., restricting it to only patients who had failed other drugs and are medically unable to take Actos (see BioCentury, Sept. 27, 2010). ...