FDA issues warning letter over mailer

THE FDA HAS issued Eli Lilly a warning letter over effectiveness claims the company made in a 2005 promotional mailer to physicians for its blockbuster antidepressant/nerve pain treatment Cymbalta.

In a letter posted to the FDA's Web site, the agency said Lilly's promotion intended to promote its indication as a treatment for diabetic nerve pain was "false and misleading" and omitted some of the most serious and important risk information associated with its use.

The agency asked that Lilly stop using the material or any similar promos. A spokesman told The Indianapolis Star that the company is working with the FDA "to gain a greater understanding of their concerns." The spokesman said Lilly will take action once it has "more clarity" on the agency's comments.

Launched in 2004, Cymbalta has become Lilly's fastest-growing drug, with global sales of $1.3 billion in 2006. -SM