Actos Lawsuits Continue to be Filed over Bladder Cancer Risks


New lawsuits alleging Actos (pioglitazone) caused bladder cancer continue to be filed, with plaintiffs claiming they were never adequately warned about the risks. According to the Louisiana Record, one recent lawsuit was filed on behalf of a man who took the drug to treat his type 2 diabetes from 2004 to 2010. He alleges that his bladder cancer resulted from taking Actos. The lawsuit seeks compensation for injuries, pain, suffering and mental anguish.

Actos lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. The MDL contained more than 4,500 lawsuits as of June 15, 2016. Some cases have resulted in large verdicts for plaintiffs.

In July, JAMA published a study indicating that there was no significantly increased risk of bladder cancer among Actos users although a small increased risk cannot be excluded. The study was funded by a grant from Takeda.

More recently, the BMJ published a study showing that Actos is linked to a 63 percent increased risk of bladder cancer. Researchers found that this risk was only associated with Actos and not rosiglitazone (brand name: Avandia), a similar drug in the same class. The risk increased with increasing dosage and duration of use, researchers found. Funding was by the Canadian Institutes of Health Research.

Actos came under increased scrutiny in June 2011, when regulators in France and Germany advised against its use. These actions were fueled by the findings of a French Medicines Agency study showing that the increased risk of bladder cancer in Actos patients was statistically significant. 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.

After reviewing interim data from the ten-year epidemiological study, the FDA said in June 2011 that use of Actos for more than one year may increase the risk of bladder cancer. The drug’s safety label was updated to reflect this risk.