The weight loss drug Belviq is being pulled from the market due to a slight elevated risk of cancer
The maker of a weight loss drug pulled it from the market Thursday on the request of federal regulators, who mentioned it posed a slight elevated risk of cancer.
Japan’s Eisai Inc. mentioned it was voluntarily withdrawing the drug, Belviq. However, the corporate mentioned in an announcement that it disagreed with the U.S. Food and Drug Administration’s interpretation of latest knowledge on the drug’s security and nonetheless believes Belviq’s profit outweighs the risk.
The FDA mentioned sufferers ought to cease taking Belviq instantly, get rid of leftover capsules and speak to their physician for recommendation on options. The company additionally advised medical doctors to inform their sufferers to cease taking the drug.
Belviq was accepted in 2012, roughly the identical time couple different promising weight loss medication hit the market. None grew to become the blockbusters they have been anticipated to be, however they provided an possibility for the many individuals combating extra weight or weight problems and associated well being issues.
Belviq was the primary drug confirmed to assist individuals drop some weight and hold it off for a number of years with out elevating their risk for coronary heart issues. That was the conclusion of a five-year, 12,000-patient examine of the drug’s coronary heart security, which the FDA required Eisai to conduct as a situation of approval.
A just lately accomplished FDA evaluation of the information from that examine confirmed 7.7% of contributors who took Belviq have been identified with cancer, barely greater than the 7.1% who developed cancer in a comparability group given dummy capsules.
There was a variety of cancers, with pancreatic, colorectal and lung cancer reported extra typically within the sufferers who took Belviq, the FDA mentioned.
The company mentioned no particular cancer screening is required for anybody who took Belviq. It famous the elevated risk was solely seen after prolonged use of the drug.
Eisai mentioned its evaluation is that Belviq has extra profit than risk for its meant sufferers. It’s particularly accepted for adults with a physique mass index of 30 and adults with a BMI of 27 who produce other circumstances that carry coronary heart dangers, corresponding to hypertension, excessive ldl cholesterol or Type 2 diabetes.
An extended-release model referred to as Belviq XR is also being pulled from the market.
In testing earlier than Belviq was accepted, almost half of contributors given Belviq misplaced no less than 5% of their weight over a 12 months, and almost one-quarter misplaced no less than 10%. Those outcomes have been greater than two instances higher than these of contributors given dummy capsules.
Of the competing medication launched about the identical time, Qsymia produced extra weight loss than Belviq. Contrave, accepted in 2014, produced related weight loss to Belviq however carried a robust warning in regards to the risk of elevated suicidal ideas and habits.
The medication’ prices harm gross sales. Belviq and Contrave retail for roughly $300 per thirty days with out insurance coverage, and Qysmia sells for about $200 per thirty days, relying on the pharmacy.
Several older weight loss program medication have been beforehand withdrawn from sale after they have been discovered to lift the risk for coronary heart valve harm, suicidal ideas or different issues.
The firm’s U.S. headquarters is in Woodcliff Lake, New Jersey.
Follow Linda A. Johnson on Twitter: @LindaJ—onPharma
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