What are the FDA-approved medications for weight-loss?

Updated: Jun 09, 2021
  • Author: Osama Hamdy, MD, PhD; Chief Editor: Romesh Khardori, MD, PhD, FACP  more...
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Few medications are available for the treatment of obesity. Examples of FDA-approved drugs that may be considered for the long-term treatment of obesity include orlistat (Xenical, Alli), the combinations of phentermine and extended-release topiramate (Qsymia), and the fixed-dose combination of bupropion and naltrexone (Contrave). Generally, the medications approved by the US Food and Drug Administration (FDA) for obesity are intended for patients with a BMI of 30 kg/m2 or more or of 27 kg/m2 or more with a weight-related risk factor (eg, diabetes, hypertension). All are indicated as adjuncts to caloric restriction, increased physical activity, and behavior modification. Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, stimulants should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

The FDA has issued a consumer alert about over-the-counter weight-loss pills that contain undeclared, active pharmaceutical ingredients. These products, which are promoted and sold on Web sites and in retail stores, may be marketed as “dietary supplements.” They have not been approved by the FDA, are illegal, and may be potentially harmful. [149] In April 2015, the FDA banned the use of the amphetaminelike stimulant (BMPEA) in supplements (sometimes labeled as acacia rigidula). [150]

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