Pediatric Weight Management (PWM) Adjunct Therapies: Use of Weight Loss Medications in Treating Obesity in Adolescents
Click here to see the explanation of recommendation ratings (Strong, Fair, Weak, Consensus, Insufficient Evidence) and labels (Imperative or Conditional). To see more detail on the evidence from which the following recommendations were drawn, use the hyperlinks in the Supporting Evidence Section below.
PWM: Collaboration with Health Care Team
The dietitian should collaborate with the health-care team regarding the use of weight-loss medications as an adjunct therapy within a multi-component pediatric weight-management program for adolescents. Clinical outcomes are likely to be enhanced with the participation of a dietitian.
PWM: Weight Loss Medication
If a weight-loss medication is selected as an adjunct therapy, then an over-the-counter or prescription gastrointestinal lipase inhibitor (e.g., orlistat), approved by the FDA for use in adolescents, may be recommended to treat obese adolescents participating in a multi-component pediatric weight-management program. Research indicates that a gastrointestinal lipase-inhibitor further improves weight status and body composition in some individuals within a multi-component adolescent weight-management program. However, the FDA has not studied or approved the use of this class of medication for children under the age of 12.
For FDA drug approval information, see http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name.
Risks/Harms of Implementing This Recommendation
Gastrointestinal Lipase Inhibitor
Adverse effects from the use of a gastrointestinal lipase inhibitor were determined by the intake level of dietary fat (the higher the intake of dietary fat, the higher the likelihood of adverse effects). Adverse effects generally improved over time. Commonly occurring adverse effects include:
- Malabsorption of fat soluble vitamins
- Increased defecation
- Oily spotting on clothing
- Soft stools
- Increased flatus
- Fatty or oily stools
- Fecal incontinence.
Conditions of Application
- If a gastrointestinal lipase inhibitor is used as an adjunct therapy, the FDA has only approved one gastrointestinal lipase inhibitor for use in weight-loss therapy among adolescents (over 12 years) http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
- Close medical monitoring is critical when over-the-counter or prescription weight-loss drugs are used as an adjunct therapy in a multi-component pediatric weight-management program.
- A daily multi-vitamin is necessary when a gastrointestinal lipase inhibitor is used.
Potential Costs Associated with Application
Including weight-loss medications within a multi-component adolescent weight-management program requires the supervision of the appropriate healthcare professional. Some programs may incur additional staffing costs to include this type of adjunct therapy.
Because research continues apace, and new drugs are approved continually, the reader is encouraged to check the FDA website for information on a particular drug to see if it has been approved for use in a pediatric population for weight loss. The list of drugs (and associated information) approved by the FDA may be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name.
Gastrointestinal Lipase Inhibitor
- A gastrointestinal lipase inhibitor may be moderately effective in promoting short-term weight loss (12 months or less), as part of a comprehensive weight-loss program (diet, exercise and behavioral therapy), in adolescents. However, application is limited by gastrointestinal adverse events.
- Long-term efficacy and tolerability of a gastrointestinal lipase inhibitor as part of a comprehensive behavioral treatment program for adolescents has not been thoroughly studied
- As seen with adults, adverse side effects are gastrointestinal, usually occur early in treatment and tend to decrease in time (Grade II).
Recommendation Strength Rationale
The combination of FDA approval (in 2003) as well as a number of well-designed and well-powered studies (Grade II) argues for a Fair rating. One gastrointestinal lipase inhibitor has been approved by the FDA for use as a weight-loss medication in adolescents (aged less than 12 years).
- Risks/Harms of Implementing This Recommendation
The recommendations were created from the evidence analysis on the following questions. To see detail of the evidence analysis, click the blue hyperlinks below (recommendations rated consensus will not have supporting evidence linked).
Chanoine J-P, Hampl S, Jansen C, Boldrin M, Hauptman J. Effect of orlistat on weight and body composition in obese adolescents. A randomized controlled trial. JAMA 2005;293:2873-2883.
Maahs D, de Serna DG, Kolotkin RL, Ralston S, Sandate J, Qualls C, Schade DS. Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents. Endocr Pract 2006;12:18-28.
McDuffie JR, Callis KA, Uwalo NG, Fallon EM, Frazier TE, Hubbard VS, Yanovski JA. Efficacy of orlistat as an adjunct to behavioral treatment in overweight African-American and Caucasian adolescents with obesity-related co-morbid conditions. J Pediatr Endocrinol Medab 2004;17:307-319.
McDuffie JR, Calis KA, Uswaifo GI, Sebring NG, Fallon EM, Hubbard VS, Yanovski JA. Three-month tolerability of orlistat in adolescents with obesity-related comorbidities. Obes Res 2002;10:642-650.
Ozkan B, Berekey A, Turan S, Keskin S. Addition of orlistat to conventional treatment in adolescents with severe obesity. Eur J Pediatr 2004;163:738-741.
Berkowitz RI, Wadden TA, Tershakovec AM, Cronquist JL. Behavior therapy and sibutramine for the treatment of adolescent obesity. JAMA. 2003;289:1805-1812.
Godoy-Matos A, Carraro L, Vieira A, Oliveira J, Guedes EP, Mattos L, Rangel C, Moreira RO, Coutinho W, Appolinario JC. Treatment of obese adolescents with sibutramine: a randomized, double-blind, controlled study. J Clin Endocrinol Metab. 2005;90:1460-1465.
Reisler G, Tauber T, Afriat R, Bortnik O, Goldman M. Sibutramine as an adjuvant therapy in adolescents suffering from morbid obesity. Isr Med Assoc J. 2006 Jan;8(1):30-2.
References not graded in Academy of Nutrition and Dietetics Evidence Analysis Process