People began filing Belviq lawsuits shortly after the U.S. Food and Drug Administration asked the drug's manufacturer, Eisai Inc., to pull it off the market. A five-year study of Belviq users convinced the FDA that the drug posed an elevated cancer risk. Belviq, or lorcaserin, was a weight reduction drug approved by the FDA in 2012 to take care of obesity. It had been also prescribed to overweight people who had serious weight-related health conditions such as for example diabetes and high blood pressure.
It had been available by prescription in its original form and in a protracted release version, Belviq XR. Both are the topic of Belviq lawsuits. Arena Pharmaceuticals manufactures Belviq at its facility in Switzerland. Eisai Inc. marketed and distributed Belviq in the United States. Both companies are named in lawsuits.
Cancer Link Led People to File Belviq Lawsuits
On Feb. 13, 2020, the FDA requested that Eisai Inc. voluntarily withdraw the drug on the potential cancer link. The agency based its decision on results from the five-year study of Belviq users that the company had conducted to ensure there were no serious cardiovascular risks related to the drug.
“We are taking this action because we genuinely believe that the risks of lorcaserin outweigh its benefits based on our completed report on results from a randomized clinical trial assessing safety,” the FDA announcement read.
When the FDA approved Belviq, it required Eisai to conduct a long-term study in to the drug's cardiovascular effects. The research involved 12,000 people, some taking Belviq and others taking a placebo.
Data from the trial revealed that 7.7 percent of the people taking Belviq developed cancer, in comparison to 7.1 percent taking the placebo.
Belviq users who developed any among three various kinds of cancer began filing lawsuits shortly following the FDA announcement.
The business complied with the FDA's request, however it issued a record saying that its interpretation of data from the research differed from the FDA's.
“Their assessment is that Belviq and Belviq XR continue to really have a positive benefit-risk profile in the in-patient population for which they are indicated,” the statement read.
The statement added that Eisai respected the FDA's decision and was working together with the agency to remove its drug from the market.