There are several thousand lawsuits filed by folks both in state and federal courts by patients who took the prescription drug pioglitazone, sold as brand name Actos and later developed bladder cancer. Doctors prescribe Actos to treat patients with Type 2 Diabetes.
Takeda Actos Bladder Cancer Verdict
On April 7, 2014, a federal jury in Louisiana found Takeda failed to adequately warn about bladder cancer risks of Actos. Jurors also found that executives of Takeda acted with wanton and reckless disregard for patient safety and awarded a total of $9 billion in punitive damages.
Actos Bladder Cancer Link & FDA Warnings
In June 2011, the U.S. Food and Drug Administration announced a drug safety alert warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA released a “Drug Safety Communication,” indicating that based on dose and duration of use, there exists a 40 percent increased risk of developing Actos bladder cancer.
Health authorities in France also suspended the use of Actos due to the risk of developing bladder cancer.
In April 2012, Health Canada, the government drug safety agency for Canada, announced a safety warning on Actos. Diabetes patients prescribed Actos for over a year had two times higher risk of bladder cancer than diabetes patients not taking Actos.
One of the most recent studies on Actos and bladder cancer was published in the British Medical Journal, May 2012 issue.
Researchers studied 115,727 patients and discovered that Actos use increased the risk of bladder cancer by 83 percent. They also noted that the risk increases with long-term use of Actos.
Actos Cancer Side Effects Lawsuits
Manufacturers of prescription drugs have a duty to patients to produce safe products and to warn patients and their doctors of any adverse health effects. The lawsuits filed by Actos patients with bladder cancer allege that Takeda breached both of these duties and Takeda is legally responsible for the harm and must pay damages.
Takeda Knew About Bladder Cancer Risk
The Actos complaints allege that Takeda had studies on laboratory animals showing an increased risk of bladder cancer when the animals were provided the drug. Takeda allegedly failed to disclose these laboratory test results to health regulators.
Actos was released in 1999, and the FDA directed Takeda to undertake a post-marketing study on the safety and effectiveness of Actos. Takeda allegedly delayed initiating the study until 2003 and designed the study as a 10-year trial. Because of this study design, the final results will not be available until after the expiration of Takeda’s exclusive patent on Actos.
Early results published in 2011 did show increased risk of bladder cancer.