Takeda Pharmaceutical Co. failed to classify “non-hospitalized or non-fatal” congestive heart failure cases associated with its type 2 diabetes drug Actos as “serious” and purposefully did not alert the Food and Drug Administration (FDA) about these cases as all drug makers are required to do, a former Takeda medical reviewer claimed in a lawsuit recently unsealed.
Helen Ge’s lawsuit claims Takeda covered up reports of the adverse events it received because it didn’t want news of serious health concerns to hurt the drug’s growing profits. She also alleges that Takeda tried to show that Actos was safer than GlaxoSmithKline’s type 2 diabetes drug Avandia, which came under federal review because of reports linking it to fatal heart attacks.
As Takeda moved to take sales away from GlaxoSmithKline’s Avandia, it was also downplaying data from studies that showed Actos was linked to bladder cancer, Ge’s lawsuit claims.
In 2007, the FDA ordered Takeda and GlaxoSmithKline to put stronger warnings on their drugs’ labels about the risk of congestive heart failure. Last year, the FDA severely restricted use of Avandia based on reports of heart attacks in patients who used the drug. Months later, the FDA issued a separate warning for Actos and the risk of bladder cancer.
Ge is suing Takeda under the federal False Claims Act and similar state statutes, and seeks to recover damages on behalf of governments. She would be entitled to 15 to 30 percent of any recovery.