Takeda Faces Actos Bladder Cancer Lawsuit

Madison, ILTakeda, maker of Actos, faces another lawsuit alleging Actos side effects. In this case, the plaintiff alleges a link between Actos and bladder cancer. The Actos bladder cancer lawsuit was filed following news that the US Food and Drug Administration updated the warning on Actos.

The lawsuit was filed by Robert and Jewell Bettorf, as reported by The Madison Record (10/03/11). The Bettorfs allege Robert began taking Actos in 2007 and was diagnosed with bladder cancer in 2008 but did not stop taking Actos until 2011. According to the lawsuit, Takeda and Eli Lilly and Company knew in 2005 about the potential risk of bladder cancer but did not properly warn consumers about that risk.

Robert Bettorf alleges that because of his use of Actos and development of bladder cancer, he has experienced pain, suffering and emotional distress. Among the allegations against the defendants are negligent failure to warn, negligence and breach of implied warranty.

Despite recent concerns about the reported risk of bladder cancer, a committee for the European Medicines Agency (EMA) has determined that Actos, known generically as pioglitazone, should remain on the market. The decision came following a period in which the Committee for Medicinal Products for Human Use recommended a new warning label for the drug, followed by France and Germany recommending doctors stop prescribing it.

France and Germany ordered doctors in June 2011 to stop prescribing Actos after a French study found a slightly higher risk of bladder cancer in patients who took pioglitazone as compared with those who did not. The highest risk appeared to be among patients who had the highest cumulative doses during the study.

In making its recommendation to keep Actos on the market, the Committee for Medicinal Products for Human Use noted that pioglitazone is a valid treatment option for some patients when other treatments have not worked. As reported by MedPage Today (10/21/11), the committee acknowledged the increased risk of bladder cancer, but recommended Actos remain available as a second or third option for patients who have not had success with other treatments.

Actos remains on the market in the US, although with a stronger warning. In August 2011, the US Food and Drug Administration (FDA) approved an updated warning label that advises patients that use of pioglitazone for more than a year may increase the risk of developing bladder cancer. Patients with active bladder cancer are not recommended to take Actos, while those with a history of bladder cancer are advised to use caution and see a doctor if they experience symptoms of bladder cancer. Symptoms of bladder cancer include blood in the urine and pain when urinating.