FDA Withdraws Approval for Belviq and Belviq XR

September 17, 2020 – The U.S. FDA has withdrawn approval for Belviq® (lorcaserin HCl) and Belviq XR® (lorcaserin HCl extended release), manufactured by Eisai. Both drugs were indicated to aid weight loss when initially approved by the FDA, but were voluntarily withdrawn from the market in February 2020 following concerns over cancer risks.

During a clinical trial, 7.7% of patients treated with lorcaserin were diagnosed with cancer, versus 7.1% of patients receiving a placebo. The FDA has determined that the risks of the drug outweigh its potential benefits.

Eisai has waived its opportunity for a hearing following the revocation of FDA approval for Belviq and Belviq XR, and does appear to be pursuing further development of lorcaserin products.