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 behaviour training, U.S. regulators said.
The U.S. Food and Drug Administration said in a letter to Lilly unit Elanco Animal Health, released yesterday, that statements on a company website, 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 behaviour modification training, the FDA 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 behavioural 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-flavoured 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-per-cent compliance."
The FDA approved Reconcile in April for use with behaviour modification to treat canine separation anxiety.