A medical reviewer from Takeda Pharmaceutical Company, manufacturer of diabetes drug Actos, is blowing the whistle on her former employer, claiming that it covered up known cases of congestive heart failure related to Actos use. Specifically, she alleges that the company did not consider “non-hospitalized or non-fatal” cases of congestive heart failure between 2007 and 2010 as “serious” and report the side effects to the FDA.
The U.S. Food and Drug Administration (FDA) regulates the production of dangerous drugs and requires negative side effects be self-reported to the agency via its Adverse Event Reporting System. The whistleblower claims that Takeda’s motivation in failing to report the cases of congestive heart failure related to Actos use was for financial gain: maintaining that Actos was a safe and effective diabetes drug would mean big profits for the Japanese drug maker.
Takeda denies any wrongdoing.
In 2010, the FDA changed the labeling requirements for Actos. It now contains a strong warning to consumers that the drug may cause congestive heart failure in some users. Congestive heart failure results when the heart becomes ineffective at pumping blood to the rest of the body.
More recently, Actos has been linked to bladder cancer in diabetes patients who’ve taken the drug for a year or longer.
Although the U.S. Department of Justice initially declined, along with 24 states, to join the former Takeda employee’s lawsuit, she plans to continue her claims against Takeda. The former medical reviewer believes that once Takeda is forced to disclosed certain information through the legal process, the truth of her claim of a cover-up by the drug manufacturer will be readily apparent.