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Nearly eight years after its questionable approval of the weight-loss drug lorcaserin (BELVIQ),[1] the Food and Drug Administration (FDA) announced on February 13 that it had asked the drug’s manufacturer (Eisai) to voluntarily withdraw the medication from the U.S. market.[2] Eisai responded that it will comply with the FDA request.
The FDA made its decision in light of new evidence from a randomized, placebo-controlled postapproval clinical trial that was required by the agency when...
Nearly eight years after its questionable approval of the weight-loss drug lorcaserin (BELVIQ),[1] the Food and Drug Administration (FDA) announced on February 13 that it had asked the drug’s manufacturer (Eisai) to voluntarily withdraw the medication from the U.S. market.[2] Eisai responded that it will comply with the FDA request.
The FDA made its decision in light of new evidence from a randomized, placebo-controlled postapproval clinical trial that was required by the agency when it approved lorcaserin to assess the drug’s cardiovascular risks. Although it did not show significant differences with respect to cardiovascular risks, the trial showed a higher risk of pancreatic, colorectal and lung cancer among lorcaserin users than among those who took a placebo.
The trial enrolled nearly 12,000 obese or overweight subjects and had an average follow-up of three years and three months. The FDA reported that 462 subjects (8%) treated with lorcaserin were diagnosed with 520 primary cancers, whereas 423 (7%) of those who received a placebo were diagnosed with 470 cancers in the trial.
The FDA is advising current users of lorcaserin to stop taking the drug and to dispose of any unused pills by taking them to a drug take-back location. The agency stated in its announcement that it is not recommending any special cancer screening for patients who have used the drug.
Public Citizen’s Health Research Group predicted that lorcaserin would eventually be removed from the market and designated it as Do Not Use as soon as it was approved by the FDA in 2012.[3] In a letter to the FDA opposing approval, we cautioned that preapproval clinical trials suggested possible cardiovascular risks (particularly heart valve damage) with use of the drug, a concern that was highlighted by experts at the agency.[4] We also noted that the drug’s minimal benefits (approximately 3% additional weight loss compared with placebo after one year of therapy) did not outweigh its risks.
We continue to recommend against taking any weight-loss drug. Instead, we recommend lifestyle changes involving reduced-calorie diet, exercise and behavior-based weight loss interventions (including self-monitoring and behavior-change techniques, as well as counseling) for effective and safe weight loss.
References
[1] Eisai Inc. Label: lorcaserin (BELVIQ). April 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7cbbb12f-760d-487d-b789-ae2d52a3e01f&type=display. Accessed March 3, 2020.
[2] Food and Drug Administration. Drug safety communication: FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. February 13, 2020. https://www.fda.gov/media/135189/download. Accessed March 3, 2020.
[3] Public Citizen. In approving new diet drug, FDA ignores crucial safety data. Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group. June 27, 2012. https://www.citizen.org/news/in-approving-new-diet-drug-fda-ignores-crucial-safety-data/. Accessed March 3, 2020.
[4] Public Citizen. Letter to the FDA Commissioner opposing approval of lorcaserin. June 26, 2012. https://www.citizen.org/wp-content/uploads/migration/2039.pdf. Accessed March 3, 2020.
