The Obesity Society's Position on Orlistat as an Over-the-Counter Drug

 

The Obesity Society, has reviewed information related to the FDA decision regarding Orlistat's OTC status.

Safety concerns: Orlistat has a strong safety record. There is a major need for a multiple vitamin supplement (fat soluble vitamins) and there is some interference with absorption of other lipid soluble drugs. It is essential that any OTC bottle clearly note very carefully both concerns and strongly recommend that multiple vitamin supplements be taken with Orlistat OTC.

Potential for abuse: As an OTC drug, there is concern that this availability will lead to abuse by people who are suffering from eating disorders. Furthermore, this drug is only advisable as an adjunct to individuals engaged in an active weight loss program that focuses on a healthy diet, caloric restriction, and increased physical activity. The 60 mg dose of Orlistat will be less effective than the currently prescribed higher dose.

OTC availability will most likely increase significantly Orlistat usage since doctors uncommonly prescribe anti-obesity drugs. The FDA must require a careful monitoring system be established to study the uses and abuse of Orlistat as an OTC drug.

Age limitations on Orlistat use: Orlistat must be limited to persons aged 14 and older. The research seems to indicate that trials have been done with adolescents and there were no serious problems. This research found that "Orlistat, in combination with diet, exercise, and behavior modification, improves weight management in obese adolescents"(Chanoine, Hampl et al. 2005). Again there is concern that normal or even anorexic and bulemic adolescents will use and abuse this drug.

Conflict of interest: The Obesity Society has received gifts from GlaxoSmithKline to support is annual meeting and other activities. The Public Affairs Committee, which prepared this statement, has no conflicts of interest and has been independent from the NAASO administration in preparing this statement.

References:
Chanoine, J. P., S. Hampl, et al. (2005). "Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial." Jama 293(23): 2873-83.

CONTEXT: The prevalence of overweight and obesity in children and adolescents is increasing rapidly. In this population, behavioral therapy alone has had limited success in providing meaningful, sustained weight reduction, and pharmacological treatment has not been extensively studied. OBJECTIVE: To determine the efficacy and safety of orlistat in weight management of adolescents. DESIGN, SETTING, AND PATIENTS: Multicenter, 54-week (August 2000-October 2002), randomized, double-blind study of 539 obese adolescents (aged 12-16 years; body mass index [BMI] >or=2 units above the 95th percentile) at 32 centers in the United States and Canada. INTERVENTIONS: A 120-mg dose of orlistat (n = 357) or placebo (n = 182) 3 times daily for 1 year, plus a mildly hypocaloric diet (30% fat calories), exercise, and behavioral therapy. MAIN OUTCOME MEASURES: Change in BMI; secondary measures included changes in waist and hip circumference, weight loss, lipid measurements, and glucose and insulin responses to oral glucose challenge. RESULTS: There was a decrease in BMI in both treatment groups up to week 12, thereafter stabilizing with orlistat but increasing beyond baseline with placebo. At the end of the study, BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo (P = .001). Compared with 15.7% of the placebo group, 26.5% of participants taking orlistat had a 5% or higher decrease in BMI (P = .005); 4.5% and 13.3%, respectively, had a 10% or higher decrease in BMI (P = .002). At study end, weight had increased 0.53 kg with orlistat and 3.14 kg with placebo (P<.001). Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass. Waist circumference decreased in the orlistat group but increased in the placebo group (-1.33 cm vs +0.12 cm; P<.05). Generally mild to moderate gastrointestinal tract adverse events occurred in 9% to 50% of the orlistat group and in 1% to 13% of the placebo group. CONCLUSIONS: In combination with diet, exercise, and behavioral modification, orlistat statistically significantly improved weight management in obese adolescents compared with placebo. The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group.

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