- Lucas Jackson/Reuters
- In a clinical trial conducted on 12,000 people, the US Food and Drug Administration found that people who took Belviq were diagnosed with cancer more than the people who didn’t.
- Belviq was first approved by the FDA in 2012 and works by making people feel fuller than they actually are.
- The FDA is still evaluating the results of the trial and is advising patients and health professionals to weigh the potential health risks when taking Belviq.
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A weight-loss drug is now tied to a “possible increased risk of cancer,” according to the US Food and Drug Administration, which is advising patients and healthcare professionals to consider the potential risks when prescribing or taking Belviq or Belviq XR.
The drug, which was first approved by the FDA in 2012, works by targeting the part of the brain that regulates appetite, making the people who take the pill feel fuller than they actually are.
The recent findings came as a result of a clinical trial Eisai Inc., the manufacturer of Belviq, was required to conduct in order to maintain the FDA’s stamp of approval. The randomized trial was conducted on 12,000 participants over five years and found that people taking lorcaserin, the generic name for Belviq, were diagnosed with cancer more often than people who weren’t.
While the FDA isn’t certain that Belviq causes cancer, the findings were enough to send out health alerts to the public. “We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA said in a statement.
“Patient safety is Eisai’s priority and we will continue to work closely with the FDA to evaluate the clinical trial results,” a Belviq representative wrote in a statement to Insider. “We recommend patients speak directly with their healthcare professional in order to make the best decision about their medical treatment.”
- Crystal Cox/Business Insider
Belviq is one of five FDA-approved weight loss drugs on the market. It was never approved for use in Canada, as the company could not address some questions the Canadian health regulators had. In 2013 Consumer Reports recommended people skip the drug, pointing out that the FDA initially rejected Belviq because “of a risk of tumors found in animal studies.”
The European Medicines Agency also rejected the drug, meaning it was never approved for use in Europe.
The latest findings come on the heels of new research that shows that the FDA has recently been approving more drugs at a faster pace – but with less evidence.
It also revives concerns about the dangers of weight-loss pills. Fenfluramine-phentermine, known as fen-phen, for example, was hailed as a miracle diet pill, then found to cause serious heart problems. Sibutramine was yanked off the market after it was linked to heart attacks and strokes. Topiramate, which is currently on the market, has been linked to birth defects. Most stimulant-type weight loss drugs have side effects of insomnia, restlessness, and higher blood pressure.
Most experts recommend skipping pills and sticking to sustainable lifestyle changes instead. “There’s no magic pill, it’s just hard work, discipline, and consistency. The slow and steady approach is best,” celebrity trainer Sebastien Lagree previously told Insider. “If the promise seems really far-fetched, it probably is.”