Girardi | Keese

Actos Lawsuit Alleges Drugmaker Was Aware of Adverse Effects

A recent whistleblower lawsuit alleges that drugmaker Takeda Pharmaceutical Co. hid some of the adverse effects of its diabetes-drug Actos from federal regulators. The whistleblower alleges that the company was aware of a link between its dangerous prescription drug and hundreds of congested heart failure cases but opted not to report these events in the U.S. Food and Drug Administration's Adverse Event Reporting System.

"These events were not properly identified or reported in the FDA's safety database," the whistleblower alleges. "Takeda's motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos's safety profile and to increase sales."

It is fairly common for drugmakers to downplay the adverse effects of their pharmaceuticals in order to make a profit. Takeda faces a slew of lawsuits related to Actos which was also shown to increase the rate of liver cancer in long-time users. The whistleblower also alleges that Takeda was aware of the link between its drug and liver cancer but downplayed the information.

The company declined to comment on the specific allegations in the whistleblower report but submitted a statement indicating that the company complies with all U.S. reporting laws.

Source: Bloomberg, "Takeda Hid Actos Adverse Effects From Regulators, Suit Says," David Voreacos, March 7, 2012

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