FDA Approves Labeling for Use of Xenical® (orlistat) in Management of Obesity in Adolescent Patients Aged 12 to 16 years

Only Prescription Weight-loss Treatment Approved with Labeling for Use in Management of Obesity in Adolescents

Background

Overweight and obesity has reached epidemic proportions in the United States. In fact, 15% of adolescents in the U.S. are currently obese and 30% are overweight. Now, with the first weight-loss medication approved by the FDA with labeling for use in the management of obese adolescents, these patients have a new option.

Adolescents who are obese are at greater risk of being obese as adults and of developing serious health problems, including type 2 diabetes and heart disease, and have an increased risk of mortality.

This is the first approval of its kind for a prescription weight-loss treatment. Approved by the FDA in April of 1999 as a weight-loss treatment for adults, there have been more than 16.7 million patient treatments with Xenical worldwide.

Soundbites

• Physician soundbite Marc S. Jacobson, M.D., attending physician and director of the Center for Atherosclerosis Prevention in the Division of Adolescent Medicine at Schneider Children's Hospital of North Shore-Long Island Jewish Health System
• Mom of overweight teen

VIDEO PROVIDED BY: Roche