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Type 2 diabetes drug pioglitazone (Actos) under review following French study | Global Media Post 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. �In addition to Actos, a product called Competact that combines pioglitazone with metformin was included in the suspensions. �The EMA released a statement noting that it started its own review of pioglitazone in March but was not ready to pull the drug yet. �The agency s Committee for Medicinal Products for Human Use is currently reviewing all relevant data, including data from pharmacoepidemiological studies, non-clinical and clinical data, post-marketing reports of bladder cancer, and published data to assess their impact on the balance of benefits and risks of these medicines.
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