Litigation over Actos’ (pioglitazone) alleged bladder cancer risks continues to build. According to the Louisiana Record, a recent lawsuit was filed on behalf of a man who took the type 2 diabetes drug from 2004 to 2010. He was subsequently diagnosed with bladder cancer. As with thousands of other Actos lawsuits, he alleges the drug is blame for his bladder cancer. The suit also accuses Takeda of failing to warn about the risks. The lawsuit seeks compensation for injuries, pain, suffering and mental anguish.
More than 4,500 lawsuits are pending in an Actos federal multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. Actos lawsuits have been building for several years, with some cases resulting in large verdicts for plaintiffs.
A study published in the July issue of JAMA found no significant increased risk of bladder cancer among Actos users, but notes that a small increased risk cannot be excluded. The study was funded by a grant from Takeda.
The BMJ published a more recent study in March, showing that Actos is linked to a 63 percent increased risk of bladder cancer. The study found that this risk was only associated with Actos and not rosiglitazone (brand name: Avandia), a similar drug in the same class. Researchers found that the risk increased with dosage and duration of use. The study was funded by the Canadian Institutes of Health Research.
Actos came under public scrutiny in 2011, when the drug was suspended in France and Germany.
A French Medicines Agency study found a significantly increased risk of bladder cancer in Actos patients. The study involved data from 1.5 million patients from 2006 to 2009. Takeda withdrew Actos from the French and German markets in August 2011.
The FDA updated the Actos warning label in June 2011, warning that use of the drug for more than one year may increase the risk of bladder cancer. The warning was based on a review of interim data from a ten-year epidemiological study.