Dangerous Drugs

FDA requests weight-loss drug Belviq be withdrawn from market over link to cancer

February 28, 2020

The FDA’s announcement came in January after the clinical trial found that more patients taking lorcaserin were diagnosed with cancer compared to those taking a placebo.

Lorcaserin, which is marketed under the brand name Belviq or Belviq XR, is a prescription weight-management medicine used to help with weight loss in adults who are obese, overweight, or have weight-related medical problems. Approved by the U.S. Food and Drug Administration (FDA) in 2012, Belviq works by increasing one’s feelings of fullness so that less food is consumed.

Potential risks outweigh benefits, according to FDA

Results from a clinical trial assessing the safety associated with taking Belviq show a possible increased risk of cancer, according to the FDA. Accordingly, the FDA has requested that Eisai, Inc., the manufacturer of the drug, voluntarily withdraw it from the market. Eisai has since submitted a request to do so. The FDA adds, “We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety” (1).

The FDA’s announcement came in January after the clinical trial found that more patients taking lorcaserin were diagnosed with cancer compared to those taking a placebo. Specifically, the FDA’s analysis of the study observed a 7.7 percent rate of cancer diagnosis in patients being treated with lorcaserin, compared to 7.1 percent of those in the placebo group. The trial, which was randomized, double-blind, and placebo-controlled, followed 12,000 patients over 5 years and was a condition to the FDA’s approval of the drug back in 2012. Several different types of cancer were reported, including pancreatic, colorectal, and lung cancer.

Cause of the cancer still uncertain

Upon alerting the public of the results of the trial, the FDA adds, “At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review” (2). In the meantime the FDA has urged individuals to stop taking the drug and consult with their health care professionals about alternative weight-loss medicines and programs. The FDA does not recommend special screenings for those who have taken the drug at this time.

Eisai has stated in a press release that their interpretation of the data from the trial differs from that of the FDA. “The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated” (4). Eisai adds, though, that they respect the FDA’s decision and are working closely with the Agency on the withdrawal process.

References

1.      https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr

2.      Ibid.

3.      https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market

4.      http://eisai.mediaroom.com/2020-02-13-Eisai-to-Voluntarily-Withdraw-BELVIQ-R-BELVIQ-XR-R-in-the-U-S

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