FDA Approves First New Weight-Loss Drug in 13 Years

The FDA has approved lorcaserin (Belviq) as an adjunct to diet and exercise for ongoing weight management — the first new weight-loss drug to be approved in the U.S. in 13 years.

Lorcaserin is approved for use in adults with a BMI of 30 or more, or for those with a BMI of 27 or more who have at least one weight-related condition (type 2 diabetes, dyslipidemia, hypertension). In trials, lorcaserin recipients lost roughly 3.5% of body weight after 1 year.

Lorcaserin activates the brain's serotonin 2C receptor, which may help people feel full after eating smaller amounts. Treatment can cause serotonin syndrome, especially when taken with medications that raise serotonin levels or activate serotonin receptors, including antidepressants and migraine drugs.

Heart valve abnormalities, a concern with previous antiobesity drugs, did not appear to differ between patients treated with lorcaserin and those on placebo. However, the FDA warns that it should be used with caution in patients with congestive heart failure, because such patients may have higher levels of serotonin 2B receptors.