• October 4, 2007

The U.S. Food and Drug Administration has asked Eli Lilly and Co. to stop a Cymbalta promotion that makes misleading claims and understates risk. Cymbalta is best-known for the "Depression Hurts" DTC marketing campaign.

The FDA says that a mailer for the fast-selling anti-depression drug overstates effectiveness and "omits some of the most serious and important risk information associated with its use." It asks Lilly to "immediately cease" disseminating the material. The company is working with the FDA "to gain a greater understanding of their concerns," says Lilly spokesman Charlie McAtee, according to the Associated Press. Lilly will take action once it has "more clarity" on the agency's comments, he says.

In addition to depression, Cymbalta also treats diabetic nerve pain and general anxiety disorder. The mailer promotes the drug's use for diabetic nerve pain, and states that those patients experienced "significantly less pain interference with overall functioning" when using the drug. The FDA letter noted that this "has not been demonstrated by substantial evidence or ... clinical experience." The FDA also states that the mailer doesn't reveal risks for patients with certain conditions and did not give precautions about liver toxicity, among other concerns.

--Tanya Irwin