A New York woman has claimed that Belviq (lorcaserin) manufacturer Eisai Inc. has been aware for years that the weight loss medication posed a cancer risk.
The woman filed a class action complaint against Eisai in March. The complaint accuses Eisai of putting the drug on the market despite having evidence that the medication was defective.
Eisai voluntarily pulled Belviq from the market in February after the U.S. Food and Drug Administration requested they do so.
“By that point, unfortunately,” the woman’s complaint reads, “the damage had already been done.”
The lawsuit also names Arena Pharmaceuticals Inc. and CVS Health Co. Arena licensed and developed lorcaserin and the woman purportedly purchased Belviq from CVS.
The complaint says the FDA had initially rejected Arena’s first application for lorcaserin approval in 2010, “due to safety concerns, specifically cancer risk.” An Arena animal study they started in 2007 purportedly concluded that lorcaserin caused cancer in rats.
Belviq was finally approved in 2012, but the FDA required a clinical trial to assess stroke and heart attack risks. That study led to renewed concerns about cancer.
The complaint says Belviq would have never been approved by the FDA if Eisai and Arena would have been open and honest with the FDA about the animal study which found cancer risks.
“Eisai and Arena persisted in pushing the medications to market,” the complaint says, “reaping tens of millions of dollars of profit from unsuspecting consumers.”
The trial which the FDA mandated found that 7.7 percent of lorcaserin patients were diagnosed with cancer compared to 7.1 percent of placebo patients. That trial discovered that colorectal, lung and pancreatic cancers were more frequently diagnosed in the lorcaserin group when compared to the placebo group. The FDA says an increased risk of cancer was only seen in patients who took the medication for an extended period of time.
The trial involved 12,000 obese or overweight men and women. The trial patients had either type 2 diabetes mellitus or diagnosed cardiovascular disease, another cardiovascular risk factor and were at least 50 years old for men or 55 years old for women.
Eisai spokeswoman Libby Holman said Belviq “has a positive benefit/risk profile” in an email, “demonstrated by an extensive body of research undertaken by Eisai, its partners and independent medical research in 30 clinical trials involving 22,100 patients over the last 15 years.”
“This lawsuit is without merit,” Holman said, and Eisai “intends to vigorously defend against this claim.”