FDA: Obesity Drug Lorcaserin Exits US Market Over Cancer Concerns

After wrapping up the review announced last month, the FDA has asked the manufacturer, Eisai, to withdraw the agent.

FDA: Obesity Drug Lorcaserin Exits US Market Over Cancer Concerns

The US Food and Drug Administration has asked the manufacturer of obesity drug lorcaserin (Belviq/Belviq XR) to take the drug off the US market due to its risk of cancer.

Eisai, which makes the agent, has submitted a voluntary request to withdraw it.

The announcement, posted to the FDA MedWatch website yesterday, comes one month after the agency said it was reviewing clinical trial results, calling the cause of cancer “uncertain,” based on its preliminary review.

In its alert yesterday, the FDA clarified: “We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety.”

The agency approved lorcaserin in 2012 and, as part of that approval, asked Eisai to conduct CAMELLIA-TIMI 61, a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular events. That trial ultimately found no meaningful difference in rates of major adverse cardiovascular events, but as the FDA notes in its alert, their analysis suggested that more patients taking lorcaserin (7.7%) were diagnosed with cancer compared with those taking a placebo (7.1%), equivalent to one additional cancer per 470 patients treated for 1 year.

“A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung,” the FDA notes. While there were no apparent differences in the incidence of cancer between the active and placebo groups in the first few months of the trial, the “numerical imbalance” increased over longer duration of lorcaserin use.

Physicians should stop prescribing and dispensing the drug and should contact patients currently taking it, telling them to stop and why, the FDA says. Patients should stop taking lorcaserin then return it to their pharmacies, and if they can’t, the FDA offers instructions for disposing the drug safely in household trash.

No special screening for cancer is recommended.

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