The Food and Drug Administration has issued a warning that use of Actos (pioglitazone) – which fights diabetes – for more than 12 months can lead to a 40 percent increase in bladder cancer risk over those who take the drug for short term use.
The FDA, in only issuing a warning, stopped short of its counterparts in France in Germany, which last week suspended distribution of Actos, made by Takeda Pharmaceuticals.
The FDA based its decision on data from a five-year interim analysis of an ongoing 10-year epidemiological study. "The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone," the FDA said.
Sheller, P.C. currently is investigating possible claims related to Actos. If you or someone you know has taken Actos and developed bladder cancer, call 1-800-883-2299.