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Eisai withdraws weight loss drug Belviq after FDA highlights cancer risk

Published on 14/02/20 at 10:21am

The FDA has requested that Eisai withdraw its weight loss drug Belviq (lorcaserin) and Belviq XR from the US market after clinical trial data indicated that those receiving the drug exhibited an increased incidence of cancer.

The findings arose from a review of trial results last month, from which it was determined that the "potential risk of cancer associated with the drug outweighs the benefit of treatment," according to the FDA's Center for Drug Evaluation and Research, Janet Woodcock.

"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," she added.

Eisai confirmed it would comply with the request, and will “voluntarily withdraw from the market and discontinue sales” in the US. This is in spite of the fact that Eisai disagreed with the FDA’s reading of the data, and still believes that Belviq presents a positive benefit/risk profile.

Belviq was originally approved in 2012 with the caveat that trials continued to evaluate the drug’s cardiovascular risks, but these trials instead revealed a risk of a range of cancers including lung, pancreatic, and colorectal.

Matt Fellows

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