Xenical
April 26, 1999
FDA
Press Release: Rockville, Maryland,
Xenical:
Prices and Ordering Information
The Food and Drug Administration
has approved Xenical, a new drug to treat obesity. Xenical is
the first drug in a new class of non-systemically acting
anti-obesity drugs known as lipase inhibitors.
Unlike other obesity drugs,
Xenical prevents enzymes in the gastrointestinal tract from
breaking down dietary fats into smaller molecules that can be
absorbed by the body. Absorption of fat is decreased by about
30 percent. Since undigested triglycerides are not absorbed,
the reduced caloric intake may have a positive effect on
weight control.
The effects of Xenical on weight
loss, weight maintenance, and weight regain and on a number of
obesity-related illnesses were assessed in seven long-term
multicenter, clinical trials. These studies included about
2800 patients treated with Xenical and 1400 patients treated
with placebo. A well-balanced, reduced- calorie diet was
recommended for all patient in the weight-loss and
weight-maintenance study periods. The diet was intended to
decrease caloric intake by 20 percent and to provide 30
percent of calories from fat. In addition, all patients were
offered nutritional counseling.
Of the patients who completed one
year of treatment, 57 percent of the patients treated with
Xenical and 31 percent of the placebo-treated patients lost at
least 5 percent of their baseline body weight.
The recommended dose of Xenical
is one capsule with each main meal that includes fat. During
treatment, the patient should be on a nutritionally balanced,
reduced-calorie diet that contains no more than 30 percent of
calories from fat. Xenical is indicated for obese patients
with a body mass index (BMI, a measure of weight in relation
to height), of 30 or more, or for patients with a BMI of 27 or
more who also have high blood pressure, high cholesterol, or
diabetes. A person who is 5'5" in height and weighs 180 pounds
would have a BMI of 30.
Because Xenical reduces the
absorption of some fat-soluble vitamins and beta carotene,
patients should take a supplement that contains fat soluble
(A, D, E, and K) vitamins and beta carotene. The most common
side effects of Xenical are oily spotting, gas with discharge,
fecal urgency, fatty/oily stools and frequent bowel movements.
Xenical is manufactured by Roche
Laboratories Inc.
