A recent clinical trial assessing the safety of weight-loss drugs Beliviq and Belviq XR (lorcaserin) has led to the FDA issuing a public alert, warning that the drug may contribute to cancer risk, according to forbes.com
What We Know:
- In 2012, Lorcaserin Belviq and Belviq XR were approved by the FDA for assisting weight-loss with a combination of reduced-calorie diet and increased physical activity in obese-overweight adults. The drug did in fact work by increasing feelings of fullness to reduce the amount of food eaten and was available in two tablet-based forms, Belviq and Belviq XR.
- Eisai Inc. is the drug manufacturer who conducted a randomized, double-blind, placebo-controlled clinical trial to evaluate the many risks of heart related problems this weight loss drug can cause on an individual. The agency said, “The trial involved around 12,000 participants over a period of five years; towards the end of the study, more patients taking the drug were diagnosed with cancer than those who took a placebo.”
- According to Forbes, “In one academic study from 2011, the drug did show the propensity to cause several different types of cancer in rat models, albeit at doses larger than the recommended clinical dose in humans. The FDA originally rejected the approval of the drug in 2010 based on these results, but later concluded that the development of these tumors were rodent-specific and unlikely to happen in humans.”
- Eisai Inc. told Newsweek, “Patient safety is Eisai’s priority and we will continue to work closely with the FDA to evaluate the clinical trial results. We recommend patients speak directly with their health care professional in order to make the best decision about their medical treatment. As indicated in the FDA’s communication, at this time, the FDA and Eisai cannot conclude that BELVIQ increases the risk of cancer.”
The FDA said, “Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer.”