Weight control medication Belviq (lorcaserin) has been found to increase the risk of cancer and has been voluntarily pulled off from the U.S. market. On February 13, 2020, the U.S. Food and Drug Administration stated that the risks of Belviq outweighed the benefits and announced that the Belviq manufacturer had agreed to voluntarily recall the drug.
This came after a five-year safety study of Belviq users linked the drug to an increased risk of three types of cancer, including lung cancer, colorectal cancer, and pancreatic cancer. In fact, a previous approval application had been rejected after studies showed incidences of several tumor types in lab rats exposed to the drug. The manufacturer was, however, able to get approval after convincing the FDA that the cancers were not likely to reoccur in humans. The FDA recommended that patients stop taking Belviq and Belviq XR and talk to health care providers about alternative medications.
Belviq is a weight loss prescription medicine approved by the FDA in 2012. It is used in combination with a reduced-calorie diet and exercise for obese or are overweight individuals who have other weight-related problems, such as high blood pressure, high cholesterol, and type 2 diabetes. Belviq works by controlling appetite. It activates serotonin receptors that play a role in a person’s appetite. The drug triggers feelings of fullness after eating smaller amounts of food. The drug also makes people feel full longer.
A person using Belviq is expected to lose 5% of his or her weight during the first 3 months of taking the drug with increased physical activity and a reduced-calorie diet. The treatment should be stopped if this amount of weight loss isn’t achieved.
Post-Marketing Study Results
When approving lorcaserin, the FDA required Eisai Inc. to conduct a randomized, placebo-controlled clinical trial to assess its cardiovascular safety. The study involved about 12,000 people across 400 sites in eight countries. These were adults who had developed or were at high risk of developing cardiovascular disease. During the three-year follow-up, those who took Belviq had greater weight loss compared to placebo without any increased risk of cardiovascular diseases.
The study subjects continued to be followed for more than five years, and it was discovered that more patients taking Belviq were diagnosed with cancer compared to those taking the placebo. Longer use of the medication correlated with increased cancer rates.