On February 13, 2020, FDA requested a voluntary withdrawal of lorcaserin (Belviq and Belviq XR) from the market following the analysis of a 5-year clinical trial assessing the cardiovascular safety of the medication. The analysis showed an increased risk of cancer among patient taking the drug. The trial, which included more than 12,000 patients, found patients who received lorcaserin were more likely to develop cancer (7.7%) compared with patients receiving group (7.1%). Reported cases included colorectal, lung, and pancreatic cancers. Eisai Inc, the drug’s manufacturer, has submitted a request to voluntarily withdrawal the medication from the market.
Patients should stop taking lorcaserin immediately and discuss alternative weight-loss options with their health care provider. FDA does not recommend special screenings for persons who have taken lorcaserin.
FDA recommends taking unused medication to a drug take back location to dispose of unused medication. If you cannot get to a drug take back location you can dispose of lorcaserin in your trash by following the instructions below:
- Mix the pills (uncrushed) with an unappealing substance such as cat litter, used coffee grounds or dirt.
- Place the mixture in a sealed container (eg, a sealed plastic bag).
- Dispose of the container in the trash.
- Remove all personal information on the empty prescription bottle or packaging and recycle.
Health care providers should stop prescribing and dispensing lorcaserin immediately. Contact patients currently on lorcaserin to inform them of the increased risk of cancer seen in the study and discuss alternative weight-loss strategies. Patients and healthcare professionals are encouraged to report any additional side effects to FDA MedWatch: www.accessdata.fda.gov/scripts/medwatch/index.cfm
More information can be found at the following links: