Cancer warning for popular diet drug Belviq after overweight patients in trial to test its safety for those at risk for heart disease developed tumors
- Belviq was approved in 2012 and it works by reducing patients’ appetites
- The FDA asked manufacturer Eisai Inc to conduct a clinical trial to determine the potential risk of heart-related problems
- At the study’s end, more patients taking Belviq were diagnosed with cancer than those taking a placebo
- It’s not immediately clear what type or types of cancer the patients had or how great the risk of cancer is
The US Food and Drug Administration (FDA) is warning the American public that a weight-loss drug may increase the risk of cancer.
In a statement on Tuesday, the FDA said a clinical trial had shown that those on a he prescription medication Belviq, also known in its generic form as lorcaserin, may face higher cancer risks than the general population does.
The trial was meant to evaluate whether the drug was safe to take for obese patients who were at risk of heart disease but, at the end of the study period, more participants had tumors after taking Belviq than a placebo.
It’s not immediately clear what type or types of cancer the agency participants developed, how great the risk is or what in the drug could be causing cancer.
In a statement on Tuesday, the FDA said a study published in August 2018 found that, at the end, patients on Belviq were diagnosed with cancer more than patients taking a placebo
‘At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk,’ the alert read.
‘However, we wanted to make the public aware of this potential risk. 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 approved Belviq in 2012 for doctors to prescribe to overweight and obese patients who have at least one weight-related condition such as high blood pressure or type 2 diabetes.
It works by activating a receptor in the brain, which reduces appetite. However, patients are encouraged to also eat a balanced diet and exercise regularly.
When approving the drug, the FDA says it required the manufacturer, Eisai Inc, to conduct a clinical trial to determine the potential risk of heart-related problems.
Around 12,000 participants were followed for five years, either taking Belviq or a placebo pill.
In August 2018, the results were published in the New England Journal of Medicine, which showed that Belviq helped people lose weight without affecting the heart in those at risk for heart disease.
Soon enough, health experts, such as Tam Fry, of Britain’s National Obesity Forum, told The Guardian the drug was potentially the ‘holy grail’ of weight-loss medicine.
But, what went unreported was that more patients taking the drug were diagnosed with cancer compared to patients taking a placebo.
Additionally, several clinical studies showed patients on Belviq saw only modest weight losses over the course of the year, about five percent of their body weight.
‘Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer,’ the FDA said.
The agency also recommends that patients on the medication speak to their doctors about whether any benefits of staying on the drug outweigh possible risks.
‘Patient safety is Eisai’s priority and we will continue to work closely with the FDA to evaluate the clinical trial results,’ Eisai Inc told DailyMail.com in a statement.
‘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.’