Lilly ads for dog drug misleading, U.S. FDA says Mon Jul 9, 2007 5:43PM
WASHINGTON, July 9 (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,
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
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.