From foodconsumer.org
FDA Okays weight loss drug for obese dogs
By Ben Wasserman - foodconsumer.org
Jan 6, 2007 - 11:40:51 AM
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Questions and Answers about Slentrol
What's going on?
The U.S. Food and Drug Administration on Friday announced its
approval of an anti-obesity medication, Slentrol (dirlotapide) for the
management of canine obesity, making it the first and only veterinary-approved
obesity drug for dogs in the
United
States. The drug is made by Pfizer.
What is Slentrol?
"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 FDA says in a
statement. Slentrol is indicated for weight management in obese or overweight
dogs only.
How is Slentrol used
to treat obese dogs?
“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, the veterinarian will assess the dog's progress at monthly
intervals, adjusting the dose depending on the dog's weight loss. 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,” the FDA says.
How is Slentrol
administered?
Slentrol in solution is administered orally either directly
into the mouth or with a small amount of food, according to Pfizer Animal
Health.
How effective and
safe is it to use Slentrol?
In clinical trials, Slentrol was shown to be safe and
effective producing consistent results in a range of dog breeds, according to
Pfizer.
Slentrol is well-tolerated and considered to be safe. But it
does cause side effects including vomiting, diarrhea, lethargy or anorexia. Dog
owners need to call their veterinarian if side effects last for two days.
How does Slentrol
work to manage dogs' obesity?
The exact mechanism remains unknown, the FDA says. But it is
believed that it helps weight loss by suppressing appetite, which prevents dogs
from eating too much, and inhibiting fat absorption in dogs.
How many dogs may
benefit from Slentrol?
In the
United
States, an estimated 40 percent of dogs or
17 million are considered overweight (5 percent to 20 percent over ideal
weight) or obese (20 percent or more over ideal weight), according to 2002 data
from the American Veterinary Medical Association.
How can so many dogs become
obese or overweight?
Dogs are like humans. They become obese or overweight
because they eat too much and do little exercise, said Claudia A. Kirk, DVM,
PhD, Associate Professor of Medicine and Nutrition,
College
of
Veterinary Medicine,
University of
Tennessee.
She said "In today's hectic world, it's a challenge for
many dog owners to find time to ensure their pets get adequate exercise. And in
our culture, we often equate food with love - without being aware of potential
adverse health consequences. For both pet owners and veterinarians trying to
manage a dog's weight, these habits can be a source of genuine
frustration."
Is canine obesity
serious?
Just like humans, obese dogs may have to face a series of
health problems. Research shows that being overweight or obese predisposes dogs
to or exacerbates potentially serious diseases. “Being overweight or obese has
been associated with increased risk of serious diseases in dogs such as
arthritis, heart disease, respiratory conditions and cancer,” Pfizer Animal
health states in a news release.
Is Slentrol absolutely
necessary for the management of dogs’ obesity?
Diet control and plenty of exercise can often effectively
help weight loss in dogs.
But dog owners
often do not have enough time to exercise their dogs and have difficulty
restricting food and treats for their dogs.
Slentrol helps owners better manage weight in their dogs.
How do I know whether
my dog needs Slentrol?
It is not easy for owners to know whether their dogs are
obese or overweight.
Talk to a
veterinarian and he will determine whether your dog should be treated, based on
the dog's weight and general health.
How and where can I
buy Slentrol?
Slentrol is a prescription medication for obese or
overweight dogs.
Slentrol will be
available only through veterinarians starting this spring, according to Pfizer.
Can other pets use Slentrol?
Slentrol is indicated for use in certain breeds of dogs only.
Talk to a veterinarian to see if your dog can be treated with Slentrol.
Slentrol should not be used in cats, dogs receiving
long-term corticosteroid therapy or dogs with liver disease, according to Pfizer.
Can Slentrol be used
in humans also?
Under no circumstances, should Slentrol be used in humans
for any purpose, the FDA says.
“To discourage human use, the label of Slentrol includes the
standard warning, "Not for use in humans. Keep this and all drugs out of
reach of children," and cites adverse reactions associated with human use,
including abdominal distention, abdominal pain, diarrhea, flatulence, headache,
nausea and vomiting,” the FDA states.
How much would it cost
to use Slentrol?
Dog owners may need to pay $1 to $2 a day to treat one dog
with Slentrol, according to news reports.
For more information on Slentrol, please see www.fda.gov/OHRMS/DOCKETS/98fr/2006-141-260-fois001.pdf and www.fda.gov/OHRMS/DOCKETS/98fr/E6-22542.htm .