ARTICLE | Company News

Eli Lilly, Takeda endocrine/metabolic news

April 14, 2014 7:00 AM UTC

A jury in the U.S. District Court for the Western District of Louisiana, ordered Takeda to pay $6 billion in punitive damages for failing to adequately warn of a risk of bladder cancer associated with diabetes drug Actos pioglitazone. In Terrence Allen, et al. v. Takeda Pharmaceuticals North America, Inc., et al, Terrence Allen alleged that Actos caused his bladder cancer and that Takeda failed to adequately warn him of the risk.

Allen - who took Actos during 2006-11 and was diagnosed with bladder cancer in January 2011 - argued that Takeda knew or should have known about the risk of bladder cancer with the thiazolidinedione (TZD) PPAR gamma agonist insulin sensitizer. Later in 2011, FDA updated Actos' label to warn that use of the drug for more than a year may be associated with an increased risk of bladder cancer. The update came after a French retrospective study of about 1.5 million diabetics showed a significantly increased risk of bladder cancer in patients receiving Actos compared with patients given other diabetes drugs. ...