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# FDA Asks Eisai to Withdraw Belviq from Market
- URL: https://www.fdaweb.com/fda-asks-eisai-to-withdraw-belviq-from-market/
- Published: 2020-02-13T12:00:00.000Z
- Updated: 2026-09-14T16:02:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146092

FDA is asking Eisai to withdraw its weight-loss drug Belviq (lorcaserin) and Belviq XR from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. An agency [drug safety communication](https://www.fda.gov/media/135189/download?ref=fdaweb.com) says Eisai has submitted a request to voluntarily withdraw the drug.

The agency says that in 1/2020 it announced it was reviewing clinical trial data and raised the possible risk of cancer associated with lorcaserin based on preliminary analysis of the data. When FDA approved lorcaserin in 2012, the communication says, the manufacturer was required to conduct a clinical trial to evaluate the risk of cardiovascular problems. The trial found that more patients taking the drug were diagnosed with cancer (7.7) than those taking a placebo (7.1%),. The five-year trial covered 12,000 patients. FDA says a range of cancer types was reported with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.

The agency says it now believes that the risks in taking lorcaserin outweigh the benefits.

The communication includes recommendations for actions by patients and by healthcare professionals.