Takeda Pharmaceutical Co. Ltd. Hid Actos Adverse Effects From Regulators, Suit Says

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.