The federal trial that just started and involving Actos, Takeda Pharmaceutical Co.’s Type II diabetes drug, includes allegations that Takeda hid risks associated with Actos from physicians and consumers.
The litigation accuses Takeda of hiding risks associated with Actos. Because of this, Takeda should be held liable for the cancer a former shopkeeper alleges that Actos caused, according to the man’s attorney, Bloomberg Businessweek reported. In his opening remarks, the man’s attorney accusing Takeda of neglecting to provide warnings that research tied Actos to bladder cancer until 2011, leading physicians and patients to believe that Actos was safe.
Takeda maintains that the man’s bladder cancer is not a result of his having taken Actos and that it adequately warned physicians and consumers about risks tied to Actos. Takeda’s attorney argued that no evidence exists “from these studies that there is any connection or causal relationship between Actos and bladder cancer,” according to Bloomberg Businweek. Despite this, many research studies have tied Actos to serious adverse reactions, including the very aggressive bladder cancer:
- May: A study of adverse event reports received by the U.S. Food and Drug Administration (FDA) during 2004-2209 suggests that Actos patients face a “disproportionate risk” of developing bladder cancer. The study also reviews about 500,000 side effect reports of people taking diabetes drugs. One-fifth of the reports involving bladder cancer also involve Actos.
- French and German regulators suspend Actos sales in those countries over related, potential risks for bladder cancer. Prior to the ban, the French Medicines Agency commissions research that reveals that Actos users are likelier to develop bladder cancer. The study involves a review of cancer rates in 155,000 people in France taking Actos from 2006 through 2009 and 1.3 million people diagnosed with diabetes and not treated with Actos. The study finds that bladder cancer risks were 22 percent greater in the Actos group; the risk was greatest in people taking a 28,000-mg cumulative dose.
- 2011: The FDA announces a review of Actos for possible bladder cancer risks based on a September 2010 safety review. The agency announces that initial data from a 10-year study submitted by Takeda did not indicate a statistically significant relationship between Actos exposure and increased bladder cancer risks; however, evidence indicates that Actos patients taking the drug for at least two years, or at the highest cumulative 28,000 mg dose, face increased bladder cancer risks.
- June 15: The FDA states that taking Actos for more than one year could lead to significant increased risks of developing bladder cancer. The FDA notes that the Actos safety label had been updated to address this risk.
- May 31: The British Medical Journal publishes a study that revealed Actos users are twice as likely to develop bladder cancer after just two years.
- July 4: The Canadian Medical Association Journal reveals that Actos users are 22 percent likelier to develop bladder cancer.
- May: eHealthMe study reveals that of 29,989 Actos users, 1,631 developed bladder cancer.