The FDA had asked Eisai to take Belviq as well as also Belviq XR off the market.
The FDA announced last month the idea was reviewing trial results on the prescription drug, also known as lorcaserin, an oral medication for obese adults, because of potential cancer risks. The agency Thursday asked people to stop taking the drug.
The “potential risk of cancer associated with the drug outweighs the benefit of treatment,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation as well as also Research, said in a statement.
The company will “voluntarily withdraw via the market as well as also discontinue sales” of the drug inside United States, Eisai said in a statement emailed to CNN.
The agency said in a separate news Discharge of which clinical trials showed lorcaserin increased the risk of many cancers, including pancreatic, colorectal as well as also lung.
“As noted in a brand new Drug Safety Communication issued today, patients should stop using the medication Belviq as well as also Belviq XR (lorcaserin) as well as also talk to their health care professionals about additional treatment options for weight loss,” Woodcock said, adding of which doctors should stop prescribing the drugs.
The FDA is actually not recommending any special cancer screenings for people who are currently taking the drug or may have inside past.
The FDA approved lorcaserin in 2012 as well as also made the medication available the following year, however continued clinical trials on the drug to evaluate cardiovascular risks. Instead, the idea found an increased cancer risk.
Eisai said the idea features a different interpretation of the data via the trial as well as also still believes the drug features a “positive benefit-risk profile,” however the idea has agreed to withdraw the idea based on the FDA’s assessment.
“Eisai respects the FDA’s decision as well as also is actually working closely with the Agency on the withdrawal process,” the company said in an statement emailed to CNN.