Actos is a drug that is manufactured by Takeda, a Japanese pharmaceutical company, and prescribed to treat type-2 diabetes. In September 2010, the FDA announced that Actos may be linked to urinary bladder cancer. This announcement was made by the FDA after a ten year epidemiological study revealed an increase in bladder cancer in patients taking Actos. After this study was published, Actos was removed from the market in Germany and France, but not in the U.S.
The FDA has since required Actos’ warning label to be revised to include the risk of urinary bladder cancer as a possible side effect.
Actos is currently marketed as a stand-alone drug or in combination form as Actoplus Met, Acoplus Met XR, and Duetact. Actos was designed to increase the cell’s sensitivity to insulin. It was widely prescribed in the United States as the “preferred medicine” for treating type-2 diabetes.
Unbelievably, there is strong evidence that suggests that Takeda, the Japanese manufacturer of Actos, knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical carcinogenicity studies, which showed an increase in drug-induced tumors in the bladders of rats. Despite these studies, which showed an increased risk of tumors, Takeda marketed and sold Actos without any warning whatsoever of an increased risk of bladder cancer.
In fact, it was only after the FDA required the revision to Actos’ warning label that doctors and patients were made aware of the risk of bladder cancer. Unfortunately, millions of Americans took Actos and were exposed to an increased risk of bladder cancer.
If you or a family member took Actos and have been diagnosed with bladder cancer, our Georgia injury lawyers would like to talk with you about your potential claims against Takeda.