In this randomized controlled study, the effects of adding orlistat (Xenical) to a program of diet, exercise, and behavior modification were measured. The adolescents who received orlistat had improved fat loss and changes in body mass index.
The adolescents took the drug for one year, and there were no major safety issues noted. The drug is already used in obese adults. The drug does have many unpleasant side effects, including increased gas and oily stools. It works by inhibiting fat absorption from the gut. It is not really absorbed by the body and so has very little chance of causing serious side effects. It is approved for use in adults in most countries and to date has been used in over 22 million patients. It has been shown to be effective and safe in adults, and it will likely be the same in adolescents. The drug was first approved by the FDA in 1999. In 2003, the FDA approved its use in adolescents, at a dose of 120 mg three times a day.
The study was published in one of the top medical journals and was peer-reviewed; it should be noted as well that the study was funded by the maker of the drug (and the results were used in part for FDA approval of the drug’s use in adolescents).
More research may be needed into this drug before using it routinely in obese adolescents, especially before using it for more than one year. It is especially important to look at long term effects, because most obese people regain weight after stopping an intervention. It may be necesary to take the drug for years to maintain weight management. It is also important to note that these teenagers also participated in diet counseling, exercise program, and behavior therapy. These are likely to improve many other areas of health as well, particularly getting regular exercise. However, insurance companies are much more likely to cover the drug and not cover nutrition and exercise counseling, even though these would be much more successful at improving health.
The problem of obesity in teenagers becoming much more common and more severe, new therapies are needed very soon.
