On June 15, 2011, the U.S. Food and Drug Administration (FDA) released a ‘Drug Safety Communication,’ informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of actos bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. In a five-year interim analysis of the Kaiser Permanente Northern California, study, the FDA found that there was no significant increase in the risk for bladder cancer in patients taking pioglitazone. However, it was found that the risk for bladder cancer did grow with increasing dose and use longer than one year. The data showed that pioglitazone treatment for over 12 months carried a 40% increased risk of bladder cancer.
In recent months, dozens of individuals throughout the United States have filed a bladder cancer actos lawsuits, alleging that Takeda pharmaceuticals failed to adequately research their medication or warn about the potential risks associated with use and knowingly sold the drug while being aware of those risks. Plaintiffs indicate that they are bringing the Actos class action to recover money damages, medical monitoring and other relief for all individuals who ingested Actos are having Actos Side effects in the United States or its territories since it was introduced in July 1999.