The FDA recently issued a press release that confirms medication containing pioglitazone could be associated with an increased risk of developing bladder cancer. Affected medications include Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni, the FDA reported.
While these medication labels already contain warnings about the risk of bladder cancer, new label updates that include data from additional studies were approved by the FDA.
The original alerts were made public in September 2010 and June 2011 based on interim results from a long-term safety study. In August 2011, the labels of pioglitazone-containing medications were changed to inform individuals about the increased cancer risk.
At that time, the FDA also required manufacturers to modify and continue the 10-year epidemiologic study to provide further information about the risks, according to the press release.