Following an interim review of its ongoing study of the drug, pioglitazone (Actos), the U.S. Food and Drug Administration issued an updated warning to patients over concerns use of the drug may be linked to an increased risk of developing bladder cancer. Five-year data revealed that although there was no overall increased risk of bladder cancer, patients taking the highest cumulative dose of pioglitazone for more than a year, were at greater risk. The FDA’s updated warning came just a few days after news that two European countries banned use of the drug.

The drug’s manufacturer, Takeda, responded to the FDA’s warning by stressing that interim data showed short-term use of Actos was not associated with the increased risk for bladder cancer. The company also stated that it will continue to investigate safety concerns related to its product and is committed to supporting the FDA’s 10-year epidemiological study of pioglitazone.

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

After rosiglitazone (Avandia) was heavily restricted in the U.S. over concerns use of the drug increased the risk for heart attack, pioglitazone became the second medication in the thiazolidinedione (TZD) class to be associated with serious side effects.


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