TUESDAY, Dec. 16, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration has approved the first-ever weight-loss drug for children. Hoffman-La Roche's Xenical (orlistat) is now permitted to treat obese 12- to 16-year-olds, the company said in a statement.
In a 54-week trial involving 539 adolescents in this age range, 27 percent of those who took Xenical achieved a 5 percent reduction in their body mass index (BMI, a ratio of height to weight), versus 16 percent who achieved that goal without the medication.
Approved for adults in 1998, Xenical works by blocking about 30 percent of the body's absorption of dietary fat. As in studies on older people, the medication did have several negative side effects in the studies on children, including loose stools and bowel control problems.
In blocking fat absorption, the drug also stems absorption of certain vitamins and nutrients, including vitamins A, D, E, and K, and beta-carotene. The manufacturer recommends that people who take Xenical also take a daily vitamin supplement.
For more information about Xenical, visit this site from Hoffman-La Roche.