Eisai, Inc. recently voluntarily pulled weight loss drug Belviq (lorcaserin) from the United States market. The move came after the United States Food and Drug Administration (FDA) requested that the medication be withdrawn from the market. That request came after the FDA announced that a clinical trial linked the drug to a possibly increased risk of cancer.
The clinical trial found that 7.7 percent of lorcaserin patients received a cancer diagnosis compared to 7.1 percent of patients taking a placebo. The trial found that lung, colorectal and pancreatic cancers occurred more often in the lorcaserin group than the placebo group. A variety of different cancers were reported in the trial. The FDA noted that only patients who took the drug for an extended period of time saw an increased risk of cancer.
The trial studied 12,000 overweight or obese men and women. The patients in the study either had diagnosed cardiovascular disease or had type 2 diabetes mellitus, an additional cardiovascular risk factor and were at least 55 years old for women or 50 years old for men.
The FDA recommends that patients immediately cease taking lorcaserin and discuss alternative medications and weight management programs with their healthcare providers. The FDA recommends disposing of lorcaserin at a drug take back location but says if that’s not possible one should dispose of the drug in the following manner:
1. Mix the medication, without crushing it, with an unappealing substance like used coffee grounds, cat litter or dirt;
2. Put this mixture into a container;
3. Place the container in your trash;
4. Delete or remove personal information from prescription labels of empty packaging or bottles, then recycle or dispose of them.
The FDA does not recommend that lorcaserin patients obtain special screening from healthcare professionals.
The FDA approved Belviq for weight loss in 2012. Pre-approval testing showed that almost half of Belviq patients lost at least 5% body weight over one year and almost a quarter lost at least 10%. These results involved over double the body weight loss compared to patients who received a placebo.
Eisai, Inc. said that, despite voluntarily recalling the drug from the U.S. market, it disagreed with the FDA’s interpretation of data regarding cancer risk and believes the benefit of Belviq outweighs the any risk associated with the drug.
The FDA said that Belviq’s cancer risk outweighs any treatment benefits from the drug.