FDA Approves Weight-Loss Pill for Teens
Xenical Is First Prescription Weight-Loss Treatment Approved to Treat Obesity in Adolescents
Dec. 16, 2003 -- The FDA has approved Xenical for use as the first prescription weight-loss medication, for treating obesity in teens ages 12 to 16 years old.
"This is very good news for adolescents struggling with overweight and obesity," says Marc S. Jacobson, MD, attending physician at Schneider Children's Hospital of North Shore-Long Island Jewish Health System, in a news release.
"Obesity is an epidemic, with the number of obese adolescents doubling over the last 20 years. Physicians and parents of overweight and obese adolescents now have a safe and effective treatment option available that will help manage their child's weight." Jacobson is also director of the Center for Atherosclerosis Prevention in the division of adolescent medicine.
Obesity Puts Adolescents at Risk
Overweight and obesity have reached epidemic proportions in the U.S.Latest estimates from the CDC show that 15% of American children between the ages of 6 and 19 were overweight or obese in 2000, and the problem continues to get worse. Obesity in children is defined as having a BMI (a measure of weight for height) greater than 95% of other kids the same age.
Poor dietary habits and physical inactivity are the two main culprits contributing to this growing health problem. 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. It also puts teens at an increased risk of death.
"If a parent is concerned that their child may be overweight, it's important to talk with their physician," says Jacobson. "Combining diet, exercise, and changes in lifestyle habits with medication can help seriously overweight adolescents manage their weight and reduce their risk of serious health problems."
Xenical Drops Pounds
As part of the FDA approval process, the agency examined the results of a study on obese adolescents aged 12 to 16. About 350 teens received 120 milligrams of Xenical three times a day with meals while just more than 180 kids received a placebo -- neither the researchers nor the study participants knew which pill they were taking. Each teen also ate a reduced-calorie diet containing no more than 30% of calories from fat.
The teens treated with Xenical had an average weight of approximately 210 pounds.
After one year of treatment, adolescents treated with Xenical had a significantly reduced BMI compared with patients receiving placebo.
Among the Xenical group, 27% had a drop of at least 5% in BMI compared with 16% of those receiving placebo.
The adolescents reportedly had little trouble tolerating Xenical and side effects were generally similar to those seen in adults treated with Xenical. The most common being oily stools.
How Xenical Works
Xenical, approved for adults in 1998 and still the only drug of its type, helps promote weight loss by blocking about 30% of dietary fat from getting absorbed into the bloodstream. The long-term effects of Xenical have not been established.
Because Xenical prevents nearly one-third of the fat in the food consumed from being absorbed, patients may experience gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended.
Xenical should not be taken if patients are pregnant, nursing, or have food absorption problems. Xenical reduces the absorption of some vitamins. Therefore, a daily multivitamin is strongly recommended.