The Food and Drug Administration requested that Eisai Inc. withdraw Belviq from U.S. markets citing concerns over the drug’s ties to cancer.
Since Belviq was approved in 2012, researchers have been studying the medication’s safety.
The FDA originally required that the drug manufacturer conduct a double-blind, randomized, placebo-controlled clinical trial that tested for risks of heart-related health problems.
The researchers analyzed approximately 12,000 participants, some of who were given Belviq while some took a placebo.
Researchers did not discover subsequent heart problems tied to Belviq, but they did find that patients taking the drug had a higher cancer diagnosis rate than those who took a placebo.
Research Links Belviq to Cancer
FDA researchers discovered increased rates of cancer in patients prescribed Belviq.
About 7.7 percent of patients who took Belviq had a cancer diagnosis compared to 7.1 percent who received a placebo.
Over the course of the trial, 662 Belviq patients were diagnosed with 520 primary cancers while the placebo group had 423 patients diagnosed with 470 cancers.
The FDA also reported that the longer a patient was on Belviq, the greater the increased risk of developing cancer.
Early studies performed on rats also hinted that Belviq might cause cancer.
Prior to the drug’s approval in 2012, manufacturer testing linked Belviq to an increased rate of cancerous tumors in rats.
The FDA was concerned with the findings, but the risks were not deemed significant enough to pull Belviq from markets.
The FDA has reversed its stance following the 2020 research that showed definitive evidence linking Belviq and cancer.
Does Belviq Cause Cancer?
The FDA announced in January that clinical trial results tied Belviq and Belviq XR to a possible increased risk of cancer.
The agency said that the drug’s cancer risks were significant enough to call for the drug to be removed from the U.S. market.
The agency notes that they cannot conclude that Belviq and Belviq XR contribute to the cancer risks, and the cause of developed cancers is still uncertain.
However, the agency noted that the risks of the medicine outweigh its benefits and recommend people using Belviq for weight loss stop taking the drug immediately.