Injuryboard.com reports that the manufacturer of Actos (pioglitazone), Takeda, performed a two-year carcinogenicity study in male and female rats. The study did not show drug-induced tumors in any organ EXCEPT for the bladder but it was determined by Takeda that the evidence did not point to risk in humans.
Takeda’s solution was to minimize their results and agree to perform a long-term study on Actos. The five-year results of the ten-year study showed that 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.” On August 4, 2011, the FDA approved an update to the Actos label which recommends that healthcare professionals should not use pioglitazone in patients with active bladder cancer and to use caution in using it in patients with a prior history of bladder cancer.
If you or a family member took Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact® and you believe developed bladder cancer, please contact the head of the pharmaceutical practice area, Todd Hageman.