Pharmaceutical company Eisai Co. will withdraw its weight loss drug Belviq after clinical trials revealed link to increased cancer risk.
The US Food and Drug Administration (FDA) has asked Eisai to remove its weight loss drug Belviq and Belviq XR from the market after clinical trials showed an increased incidence of cancer among users.
In January, the FDA announced that it was conducting a review of trial results on the drug, also known as lorcaserin.
In the announcement, the FDA said: “At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.”
The agency also called on health care professionals to determine whether the benefits of taking lorcaserin outweigh the potential risks for a patient. The FDA also asked patients currently taking the drug to talk to their doctors about the potential increased risk of cancer.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the "potential risk of cancer associated with the drug outweighs the benefit of treatment."
In response, Eisai released a statement saying the company will "voluntarily withdraw from the market and discontinue sales" of the drug in the US.
The FDA also issued another news release that clinical trials revealed lorcaserin increased the risk of a number of cancers, including pancreatic, colorectal and lung.
Woodcock mentioned: "As noted in a new Drug Safety Communication issued today, patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss."
While the drug maker has a different interpretation of the data from the trial, Eisai agreed to withdraw the drug based on the FDA's assessment.
