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How does Actos Cause Bladder Cancer?
In preclinical studies, male rats treated with Actos developed more bladder tumors than male rats treated with a placebo. This was not observed with female rats at the same dose or with mice of either sex at higher doses.
Back in 2003, the FDA requested that Takeda Pharmaceuticals the maker of Actos conduct a safety study to assess whether the drug increased the risk of bladder cancer. The FDA requested that the study be done over a period of 10 years.
During the follow-up period, there were 881 cases of newly diagnosed bladder cancer cases. After adjustment for only age, sex, and use of other categories of diabetes medications, there was a slightly elevated but not significant association of ever use of Actos bladder cancer risk.
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When the association was examined between bladder cancer incidence and increasing levels of Actos exposure, the risk of bladder cancer slightly increased with increasing dose and duration of Actos use.
After adjustment for age and sex, the risk of bladder cancer was 30% higher among those whose duration of Actos therapy was 12–24 months and 50% higher among those with more than 24 months of exposure than that among never users of Actos.
For men, after adjustment for age there was a significant increase in the relative hazard of bladder cancer with more than 24 months of exposure; the numbers for women were not reported.
This analysis demonstrated an additional increase in the relative hazard of bladder cancer with longer duration of Actos drug therapy. Are you an Actos bladder cancer victim?
