According to a whistle-blower, a U.S. unit of Takeda Pharmaceutical Co. failed to accurately report hundreds of congestive heart failure cases associated with Actos, its diabetes drug.
Takeda did not properly classify “non-hospitalized or non-fatal” congestive heart failure cases as serious over a two-plus year span, according to the complaint. Drug manufacturers are required to update the U.S. FDA’s Adverse Event Reporting System.
“These events were not properly identified or reported in the FDA’s safety database,” former Takeda medical review Helen Ge claimed in the complaint, filed in June 2010 and recently unsealed. “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.”
Takeda spokesman Hisashi Tokinoya responded by saying they comply “with all laws and regulations regarding the reporting of adverse events.”
Ge’s complaint claims that on multiple occasions, Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” When she protested, “her contract was summarily terminated,” according to the complaint.
Takeda wanted to make it appear that Actos was safer than Avandia, a competing diabetes drug, according to the complaint.
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