The most recent lawsuit (case number 13-L-16) involves 38 people who allege they developed bladder cancer as a result of using Actos. According to The Madison-St. Clair Record (2/1/13), all 38 plaintiffs say they were not aware that the risk of developing bladder cancer increased if Actos was taken for more than a year. Furthermore, they allege, Takeda Pharmaceuticals was aware of the risk, but failed to warn patients. The lawsuit seeks more than $1.05 million, plus costs and fees.
On June 15, 2011, the US Food and Drug Administration (FDA) issued a warning that the use of Actos (known generically as pioglitazone) for more than one year “may be associated with an increased risk of bladder cancer.” At the time, the FDA noted that information about the risk would be added to the warning label of drugs that contain pioglitazone.
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Furthermore, a study conducted in France suggested an increased risk of bladder cancer associated with pioglitazone over other anti-diabetic medications. That study resulted in France suspending the use of Actos.
The FDA noted that it would continue evaluating information from the 10-year study as it became available.
Concerns about Actos are high enough that in August 2012, Consumer Reports recommended patients use Actos only as a last resort, choosing instead metformin or other medications, and patients already taking Actos speak to their doctor about switching to another medication. Among the side effects listed by Consumer Reports were heart failure, bone fractures and bladder cancer.