BEIJING, April 14 (Xinhua) — Belviq, a weight-loss drug sold in the U.S. for eight years at the request of the U.S. Food and Drug Administration (FDA), will be removed from the shelves because research suggests it may increase the risk of cancer,media reported. Belviq, produced by Japanese drugmaker Eisai, was approved for the U.S. market in 2012, when it was approved as the first weight-loss drug in the U.S. in 13 years.
Sales of the drug peaked in the U.S. in 2015, with more than 600,000 doses available. Aishi received $49.4 million in U.S. sales from the drug in fiscal 2014.
The pills are thought to trigger chemical signals that reduce people’s appetite. But early studies in mice suggest it can also lead to cancer. Since Belviq was approved, researchers have conducted a five-year study to determine whether it could also lead to cancer in humans.
The U.S. Food and Drug Administration said Thursday that the higher risks are enough for the agency to take a rare step to remove the drug. The study showed that about 7.7 percent of Belviq users were later diagnosed with cancer, which was higher than the 7.1 percent cancer rate of placebo users. People who take Belviq are also more frequently diagnosed with certain types of tumors, including pancreatic, colorectal and lung cancers, the FDA said.
In a statement, Vesa said it believes Belviq benefits overoverweight and obese patients. However, in accordance with the changes in the FDA’s risk-benefit assessment and at the agency’s request, Aishi agreed to voluntarily withdraw these products from the U.S. market. Aoki respects the FDA’s decision and works closely with the agency. “