On September 21, 2007, the Food and Drug Administration (FDA) sent Eli Lilly and Company a notice of violation letter in regards to promotional material for the company’s depression drug Cymbalta. The letter told the company to immediately stop a promotion that makes misleading claims about the drug’s effectiveness and “omits some of the most serious and important risk information associated with its use.”

Lilly said it will wait to take action until the company has “more clarity” on the agency’s comments.

Cymbalta is used to treat depression, diabetic nerve pain, and general anxiety disorder.

The promotional material in question promotes the drug’s use for diabetic nerve pain and states patients experienced “significantly less pain interference with overall functioning” when taking Cymbalta. The FDA, in its letter, said this claim is not supported by any substantial evidence or clinical experience.

In addition, the promotional material does not inform consumers about the risks for patients with certain health conditions and does not give precautions about liver toxicity.

Source: “FDA asks Lilly to stop a Cymbalta mailer,” Wall Street Journal, October 4, 2007; Food and Drug Administration Notice of Violation Letter, September 21, 2007.