Quoted from http://www.bloomberg.com/news/2012-03-07/takeda-hid-actos-linked-heart-failure-cases-whistle-blower-claims-in-suit.html
Takeda Hid Actos-Linked Heart Failure Cases, Whistle-Blower Claims in SuitBy David Voreacos - Mar 6, 2012 7:28 PM ET
A U.S. unit of Takeda Pharmaceutical Co. (4502) failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes drug Actos, a whistle-blower claimed in a lawsuit.
The company failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010, former Takeda medical reviewer Helen Ge said in the complaint in federal court in Boston. Takeda, like other drugmakers, is required to update 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,” 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.”
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