The maker of a weight loss drug pulled it from the market Thursday at the request of federal regulators, who said it posed an increased risk of cancer.
Japan’s Eisai Inc., said it was voluntarily withdrawing the drug, Belviq. However, the company said in a statement that it disagreed with the U.S. Food and Drug Administration's interpretation of new data on the drug’s safety and still believes Belviq's benefit outweighs any cancer risk.
The FDA warned patients to stop taking Belviq immediately, dispose of leftover pills and contact their doctor for advice on alternatives. The agency also told doctor to tell patients to stop taking the drug.
Belviq was approved in 2012, roughly the same time that a couple other promising weight loss drugs hit the market. None became the blockbusters they were expected to be, but they offered an option for the many people struggling with excess weight or obesity and related health problems.
Belviq was the first drug proven to help people lose weight and keep it off for several years without raising their risk for heart problems. That was the conclusion of a five-year, 12,000-patient study of the drug’s heart safety, which the FDA required Eisai to conduct as a condition of approval.
A recently completed analysis of the data from that study showed 7.7% of participants who took Belviq were diagnosed with cancer, slightly more than the 7.1% who developed cancer in a comparison group given dummy pills.
The FDA said there was a range of cancers, with pancreatic, colorectal and lung cancer reported more often in the patients who took Belviq.
Eisai said its assessment is that Belviq has more benefit than risk for its intended patients. It's specifically approved for adults with a body mass index of 30 and adults with a BMI of 27 who have other conditions that carry heart risks, such as high blood pressure, high cholesterol or Type 2 diabetes.
An extended-release version of the drug called Belviq XR also is being pulled from the market.
The company's U.S. headquarters is in Woodcliff Lake, New Jersey.
Follow Linda A. Johnson on Twitter: @LindaJ—onPharma
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