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Belviq Withdrawn from Market Amid Cancer Concerns

Belviq Withdrawn From Market

After receiving FDA approval in 2012, Belviq and Belviq XR (lorcaserin) rose to fame as a sustainable, pharmaceutical option for overweight and obese individuals interested in weight loss. The prescription-only medication worked by increasing feelings of fullness to help patients eat less, but new research suggests that long-term use may have also increased cancer risk.

In response to these concerns, Ensai Inc. voluntarily withdrew Belviq and Belviq XR from the market and halted sales in February 2020.

The Study

When Belviq and Belviq XR received initial FDA approval in 2012, regulators requested that the drug’s manufactures, Ensai Inc., conduct a long-term trial to evaluate potential risk of cardiovascular events. The drug company agreed and began recruitment for a multinational, double-blind, placebo-controlled study, which they nicknamed CAMELLIA-TIMI 61. The study’s final results were published in The New England Journal of Medicine in September 2018 ( 1 ).

In January 2020, the FDA began reviewing data that Belviq and Belviq XR (lorcaserin) could increase patients’ risk of cancer ( 2 ).

CAMELLIA-TIMI 61 found that there was no significant difference in cardiovascular risk for patients assigned to the treatment versus placebo groups, even with long-term use. This was a positive result for the makers (and users) of Belviq and Belviq XR.

However, researches noted a discrepancy in the number of patients reporting malignancy after extended lorcaserin use. Of the approximately 12,000 study participants, 423 (7.1%) of patients in the placebo group and 462 (7.7%) of patients in the treatment group received a cancer diagnosis during the five-year study period. These numbers suggest an increased risk of malignancy after taking Belviq or Belviq XR.

A range of cancer types were reported in the initial data, but lung, colorectal and pancreatic cancers seemed to be more common in patients taking the weight loss medication for extended periods of time.

The Withdrawal

Given the results of CAMELLIA-TIMI 61 and reviewers’ decision that “the risks of lorcaserin outweigh its benefits”, the FDA requested that Ensai Inc. voluntary withdraw Belviq and Belviq XR (lorcaserin) on February 13, 2020 ( 3 ). The manufacturers complied and have stopped selling this drug in the United States.

Medical professionals should stop prescribing Belviq and Belviq XR (lorcaserin). Patients are advised to stop taking this medication immediately. Talk with your prescribing doctor about other prescription and non-prescription options to help you keep losing weight.

At this time, the “FDA is not recommending special screening for patients who have taken lorcaserin.”

Ensai Inc. maintains that, “Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated” but are nonetheless respecting the FDA’s recommendation to withdraw the medication.

For the most up to date information about Belviq and Belviq XR, visit the FDA website or Belviq.com.

References
  1. Bohula, E. A., Ingelfinger, J. R., Rosen, C. J., Boulware, D. R., Woloshin, S., Klompas, M., Steering Committee. (2018, September 20). Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients: NEJM. Retrieved from https://www.nejm.org/doi/full/10.1056/NEJMoa1808721
  2. FDA Center for Drug Evaluation and Research. (2020, January 14). Possible increased cancer risk with Belviq, Belviq XR (lorcaserin). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr
  3. FDA Center for Drug Evaluation and Research. (2020, February, 13). FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Retrieved from https://www.fda.gov/media/135189/download

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