Federal regulators have requested that the manufacturer of Belviq and Belviq XR, Eisai Inc., remove the weight loss drug from the U.S. market. The Belviq recall was issued on the heels of a review of Belviq clinical trial data, which found an increased occurrence of cancer in Belviq users. According to the clinical trial results, patients taking Belviq or Belviq XR as a weight loss aid may be more likely to develop pancreatic cancer, lung cancer, colorectal cancer or another type of cancer compared to patients not taking the drugs. In response to the recall request by the U.S. Food and Drug Administration (FDA), Eisai voluntarily agreed to discontinue sales of the weight loss medication, although the company says that it doesn’t agree with the FDA’s interpretation of the clinical trial data.
Belviq (lorcaserin) is a popular prescription weight loss drug approved by the FDA in 2012 for adults who are obese or those who are overweight and also have a weight-related health condition, such as high blood pressure or Type 2 diabetes. Belviq and Belviq XR, an extended-release version of the drug, can effectively control appetite by activating a neurotransmitter in the brain that triggers feelings of satisfaction and satiety, thereby making users want to eat less. However, as a condition of its approval in 2012, the FDA required Eisai to conduct a clinical trial to evaluate the potential risk of cardiovascular side effects in patients taking the medication. At the time, Belviq was believed to be the first drug proven to help people lose weight and keep it off without also increasing their risk of suffering heart problems. Because manipulating the body’s weight-controlling pathways can have a long-term effect on the heart and other metabolic systems, manufacturers of weight loss drugs must go to great lengths to prove their medications are safe.
A recent preliminary analysis of the Belviq clinical trial data suggested that individuals taking lorcaserin (Belviq or Belviq XR) may face a potential increased risk of cancer. Based on these findings, the FDA announced in January 2020 that the agency would be conducting a review of the clinical trial data. In its drug safety communication, the FDA reported that “results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).” Upon reviewing the data from the clinical trial, which was conducted in about 12,000 participants over a period of five years, the FDA found that Belviq use was associated with an increased risk of several types of cancer, including lung cancer, pancreatic cancer and colorectal cancer. The FDA has determined that the potential risk of cancer associated with Belviq outweigh the possible weight loss benefits of the medication, and therefore requested that Eisai remove the drug from the market in the U.S.
According to the FDA’s recall announcement, patients should stop taking Belviq and talk to their healthcare provider about alternative weight loss medications and weight management programs that may be available to them. The FDA also recommended that patients dispose of unused Belviq using a “drug take back” location. However, if that isn’t possible, the drug should be disposed of in the following manner:
Nearly one in three Americans is considered obese, and during its time on the market in the U.S., Belviq was a popular choice as a prescription weight loss aid, prescribed to hundreds of thousands of patients every year. Unfortunately, weight loss medications have a long history of exposing users to cardiovascular problems and other serious or potentially life-threatening side effects, and federal regulators have determined that the potential link between Belviq and cancer is enough to warrant a Belviq recall. If you or someone you know has been adversely affected by alleged side effects of a weight loss drug like Belviq or Belviq XR, don’t hesitate to seek legal help. You may have grounds to file a drug injury lawsuit against the manufacturing company, in order to pursue financial compensation for your medical bills and other damages.