ROCKVILLE, Md., Jan. 5 -- The FDA approved a diet drug today that it wants no one to even consider taking. Slentrol (dirlotapide), is an obesity agent for dogs, with nasty side effects if humans try it.
Slentrol, aimed at dogs that are at least 20% over ideal weight, will carry special warnings about its side effects when used by humans, starting with "not for use in humans."
The FDA also warned that humans who consume Slentrol may suffer abdominal distention, abdominal pain, diarrhea, flatulence, headache, nausea, and vomiting.
Stephen Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine, said Slentrol is a "welcome addition to animal therapies, because dog obesity appears to be increasing."
Surveys have found that approximately 5% of dogs in the United States are obese, and another 20% to 30% are overweight.
Slentrol is a new chemical entity, called a selective microsomal triglyceride transfer protein inhibitor, which blocks the assembly and release of lipoproteins into the bloodstream.
The mechanism for producing weight loss is not completely understood, said the FDA, but seems to result from reduced fat absorption and a satiety signal from lipid-filled cells lining the intestine.
The drug is given to the dog in varying amounts over the course of the treatment. The dog is given an initial dose for the first 14 days. After that, veterinarians are advised to assess the dog's progress at monthly intervals, adjusting the dose commensurately.
After the dog has achieved the goal weight, the drug's manufacturer recommends continued use of the drug during a three-month period, while the veterinarian and dog owner establish the optimal level of food intake and physical activity needed to maintain the dog's weight.
In dogs adverse reactions associated with treatment with Slentrol include vomiting, loose stools, diarrhea, lethargy and loss of appetite.
Slentrol is manufactured by Pfizer.