According to Bloomberg (3/13/12), a judge has appointed 19 plaintiffs' attorneys to handle what could be up to 10,000 claims against Takeda, maker of Actos. The lawsuits allege patients were exposed to an increased risk of bladder cancer because of the diabetes medication and that Takeda and Eli Lilly & Co did not provide adequate warnings about that risk. In 2011, officials announced that use of Actos was linked to an increased risk of bladder cancer.
Claims made by a whistleblower in a lawsuit reportedly bolster allegations that Takeda hid the risks associated with Actos. Helen Ge, a former Takeda medical reviewer, reportedly alleged the company did not classify "non-hospitalized or non-fatal" congestive heart failure cases as serious, even though such cases should have been reported to the US Food and Drug Administration (FDA). She further claimed that Takeda told medical reviewers to change their professional opinion regarding the classifying of adverse events.
READ MORE ACTOS SIDE EFFECTS LEGAL NEWS
Actos became a top-selling diabetes drug after rival drug, Avandia, was given strict limitations for its use. Actos has been pulled off the market in some countries overseas, including France, because of its reported link to cancer, but it remains on the market in the US. Meanwhile, the FDA announced in 2011 that use of Actos for more than a year was associated with an increased risk of bladder cancer. That announcement was made after interim data from a long-term study reportedly indicated an increased risk of bladder cancer in patients with the longest use and highest cumulative dose of Actos.
In 2007, Actos was given a black box warning, alerting patients to the risk of congestive heart failure associated with the medication.