US FDA warns four drugmakers on inaccurate promotion

The US Food and Drug Administration yesterday sent warning letters to domestic drugmakers Eli Lilly, Amylin and Cephalon, as well as the US subsidiary of German major Bayer accusing them of making inaccurate or incomplete statements while promoting their drugs.

According to the Associated Press, the letter to Lilly said a print advertisement for its antidepressant Cymbalta (duloxetine) does not adequately communicate risk information. The drugmaker said it is moving to withdraw the materials from circulation.

Amylin was warned that Byetta (exenatide), which it co-markets with Lilly for patients with type 2 diabetes, had been promoted for unapproved uses and overstated its efficacy. Both firms said they responded to the concerns and will take the necessary steps "to ensure all product communications adhere to regulatory requirements," the AP reported.