The Food and Drug Administration announced recently that prolonged use of Takeda Pharmaceutical’s diabetes drug, Actos (pioglitazone), may increase a patient’s risk for developing bladder cancer. The FDA also stated that product labeling would soon be updated to reflect the new information about the increased cancer risk.

The warning was issued by the FDA following an interim review of data collected from its 10-year study on pioglitazone. Analysis of the five-year data showed a greater likelihood of bladder cancer in patients taking the drug for extended periods of time and in the highest cumulative doses.

Actos is the world’s biggest-selling diabetes drug and became the market leader after a 2007 study revealed that use of GlaxoSmithKline’s Avandia increased the risk for heart attacks. The drug’s maker, Takeda, said the company is working with the FDA to make any appropriate updates to the prescribing information for Actos.

The FDA began its review of pioglitazone and its link to the increased risk for patients to develop bladder cancer back in September of 2010. The agency stated it will continue to monitor the drug until the 10-year study is complete.