LAW 531 IRAC wk 2 Failure to Warn, Takeda Pharmaceutical Company

Takeda, Asia’s largest drugmaker released Actos, a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (initial US approval 1999).

This drug has generated more than $16 billion in sales since its 1999 release. Executives at Osaka, Japan-based Takeda knew by 2004 that studies found links between Actos and cancer, and didn’t issue a warning until seven years later.