Cancer Risk Forces Recall of Weight-Loss Drug Belviq

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Weight-loss drug Belviq will be withdrawn from the U.S. market at the request of the Food and Drug Administration, after research tied it to increased rates of cancer.

Belviq came on the market in the U.S. in 2012 and is sold by Japanese drugmaker Eisai Co. U.S. sales of the drug peaked in 2015, with more than 600,000 prescriptions filled that year in the U.S., according to data compiled by Bloomberg and Symphony Health. Eisai’s revenue from the drug in the Americas in fiscal 2014 was $49.4 million, according to data compiled by Bloomberg.

The pill is thought to trigger chemical signals that make people want to eat less. But early studies, done in rats, gave hints that it might also cause cancer. Since Belviq was approved, researchers have been conducting a five-year-long study to look at the drug’s safety profile.

The FDA said Thursday that those higher risks were significant enough for the agency to take the rare step of calling for the drug’s removal. About 7.7% of Belviq patients had cancer diagnoses, compared with 7.1% of patients who got a placebo. Individuals taking Belviq were diagnosed more frequently with some types of tumors, including pancreatic, colorectal and lung cancers, the FDA said.

Eisai said in a statement that it believes Belviq’s benefits for overweight and obese patients outweigh the drug’s risks.

“However, based on the change in FDA’s risk-benefit assessment and as requested by the agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market. Eisai respects the FDA’s decision and is working closely with the agency,” the Tokyo-based company said in a statement.

The follow-up study was initially requested by the FDA to examine the risk of heart problems, a common concern with some weight-loss drugs. It enrolled 12,000 patients and took five years to complete. Patients in the trial were overweight or obese and either had cardiovascular disease or were at least 50 years old. The trend of higher cancer rates in Belviq patients appeared as patients took the drug for longer periods of time, according to the regulator.

The FDA warned in mid-January about possible increased risk of cancer with Belviq but said that at the time it couldn’t conclude that the drug was the cause.