Patients in the United States are not the only ones experiencing serious side effects from the diabetes drug Actos. Canadian resident Jimmy Whyte filed a new class action lawsuit on behalf of individuals who suffer from bladder cancer as a result of taking Actos. Whyte claims that Takeda Pharmaceuticals, the manufacturer of Actos, failed to adequately warn of the risks and put thousands of patients in danger.
The FDA approved Actos for treatment of type II diabetes in 1999. The drug was cleared for the same use in Canada in 2000. Since then, hundreds of plaintiffs have come forward to file a lawsuit seeking to hold Takeda Pharmaceuticals liable for their Actos related injuries.
Plaintiffs Claim Takeda Failed to Warn of Bladder Cancer
Like other plaintiffs who have suffered from Actos bladder cancer, Whyte alleges that it would have been important to know that the drug could increase his risk of the disease prior to taking Actos. In 2008, there were no warnings on the label concerning bladder cancer.
In September 2010, the FDA released a public safety communication stating that it was looking into a potential connection between Actos and bladder cancer. On June 15, 2011, the FDA released a warning to healthcare professionals and patients of the potential risks. The FDA based the warning on the results of a 10-year epidemiological study that found those patients taking Actos for longer than 12 months were at a 40 percent increased risk of bladder cancer.
Lawsuits Claim Takeda Was Aware Long Ago
The Canadian class action Actos lawsuit was filed in the Superior Court in Montreal. Like many of the lawsuits filed in the U.S., it states that Takeda knew or should have known about the risks. In fact, animal studies conducted prior to FDA approval of Actos showed drug-induced tumors at doses equivalent to those taken in a clinical setting. The 2005 study also found that patients taking Actos were more at risk of bladder cancer than those taking similar medications.
It was not until the FDA warned about the risk of bladder cancer that the Takeda made changes to the Actos label. On August 14, 2011, the FDA approved a new labeling requirement that mandated changes to the Warnings and Precautions section of the Actos label. It now warns patients about the risks of bladder cancer.
Health Canada made a similar label change on April 19, 2012, after a safety review revealed that long-term Actos use increased the risk of bladder cancer.
Canadian Study May Have Prompted Lawsuit
This new class action lawsuit may be in response to a recent study published in the Canadian Medical Association Journal. Researchers analyzed ten previously published studies involving over two million Actos patients. They concluded that Actos increased the risk of bladder cancer by 22 percent. This study likely increased awareness surrounding the link between the drug and the disease.
