Actos News

European Medicines Agency Recommends New Warnings
for Actos Bladder Cancer Risk
Thursday, April 19, 2012

In finalizing their review of the diabetes drug pioglitazone, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) maintains that there is a risk of bladder cancer for patients taking pioglitazone-containing drugs like Actos. The CHMP reviewed data from epidemiological studies, clinical studies, preclinical studies and spontaneous reports. All evidence pointed to an increased risk of bladder cancer in patients using pioglitazone. The EMA is advising doctors not to prescribe pioglitazone to patients with a history of bladder cancer. Additionally, the EMA advises doctors to properly assess the risk factors for bladder cancer in each patient before prescribing pioglitazone drugs such as Actos. Lastly, the CHMP has asked the marketing authorization holder to conduct a large-scale European study with specific attention paid to pioglitazone's risk period. More analysis is needed to discover whether the risk of bladder cancer is an early effect or if the risk of bladder cancer increases with higher dosages and prolonged exposure to pioglitazone. Read more