Lilly ads for dog drug misleading, U.S. FDA says

Last Updated: 2007-07-10 11:00:43 -0400 (Reuters Health)

WASHINGTON (Reuters) - Eli Lilly and Co used misleading claims to promote a version of Prozac for dogs to treat separation anxiety, neglecting to mention that dogs in a trial also got behavior training, U.S. regulators said.

The Food and Drug Administration said in a letter to Lilly unit Elanco Animal Health released on Monday that statements on a company Web site, in a veterinary magazine advertisement, and in other promotions suggested Reconcile was more effective than studies have shown and were misleading.

Lilly's materials touted the percentage of dogs that improved with Reconcile compared with a placebo, but failed to mention that both groups received behavior modification training, the FDA letter said.

The promotions "suggest that the product is more effective than has been demonstrated," the FDA said.

The materials also did not mention that some dogs improved with the behavioral training alone, according to the FDA.

Reconcile contains fluoxetine hydrochloride, the same ingredient in Lilly's human antidepressant Prozac. The dog version is a chewable, beef-flavored tablet.

The FDA asked Lilly to stop using the claims it said were misleading and to outline a plan to circulate corrective messages to the audiences that received the promotions.

Lilly spokeswoman Joan Todd said the company "takes the letter's findings seriously" and would work with the FDA "to ensure 100 percent compliance."

The FDA approved Reconcile in April for use with behavior modification to treat canine separation anxiety.

The FDA letter was dated June 26 and posted on the agency Web site on Monday at http://www.fda.gov/foi/warning_letters/s6409c.pdf .