FDA reviewing safety of Actos diabetes drug
The U.S. Food and Drug Administration said on Friday its has begun a safety review of diabetes drug Actos after receiving early results from a long-term study designed to evaluate the risk of bladder cancer in people treated with the drug.
The early data showed an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug, the agency said in a statement.
The FDA said the preliminary results are based on 5-year data from an ongoing 10-year trial by the drug's maker, Takeda Pharmaceutical Co Ltd.
Actos is in the same class of drugs as GlaxoSmithKline PLC's Avandia, which has not been associated with bladder cancer but has been linked to heart risks.
The FDA said patients should not stop taking Actos unless told to do so by their doctor.
Sep 22, 2010