Popular weight loss drug Belviq is being recalled after a safety clinical trial showed an “increased occurrence of cancer.” Following the trial, the U.S. Food and Drug Administration (FDA) requested a Belviq recall from Eisai Co., the manufacturer. Eisai acceded to the FDA’s request, though the company claims that their interpretation of the clinical trial is different from the FDA’s findings. Here is what we know about this medication recall.
What is Belviq?
Belviq, also sold as Belviq XR and generic lorcaserin, is a drug that helps people lose weight. The drug reportedly triggers chemicals in the brain that control appetite. The drug helps people “want to eat less.” People who take Belviq feel full quicker, which means they eat less.
Doctors prescribe Belviq to patients who are obese, including those suffering from high cholesterol, diabetes or high blood pressure. It does not treat the underlying condition, but is a safe weight loss method for these patients.
Why is Belviq Being Recalled?
Early studies of Belviq in rats showed the potential for an increased risk of cancer. When it was approved in 2012, the FDA mandated that the drug must undergo a “randomized, double-blind, placebo-controlled clinical trial.” The trial included 12,000 patients and ran the course of five years. Participants in the trial were all overweight or obese, and were either over 50 years old or suffering from cardiovascular disease.
In January 2020, having not yet completed the evaluation, the FDA announced,
“…More patients taking lorcaserin were diagnosed with cancer compared to patients taking a placebo, which is an inactive treatment.”
Now that the evaluation is complete, the FDA is reiterating their concerns. In February 2020, the FDA said,
“We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results from a randomized clinical trial assessing safety.”
The FDA only names a few possible cancers identified in the Belviq group, including lung, colorectal and pancreatic cancers. According to the FDA report, around 7.7 percent of patients taking Belviq developed cancer, compared to 7.1 percent of patients taking the placebo. This increased rate is what led the FDA to call for removal of the drug.
Eisai argues that the benefits of Belviq do outweigh the risks, however, they are working with the FDA. In a statement to CNN, Eisai said they will “voluntarily withdraw from the market and discontinue sales.”
How Many People are Affected by the Belviq Recall?
Belviq is a popular weight loss drug, and therefore, could impact hundreds of thousands of people. Following approval in 2012, Belviq prescriptions skyrocketed, with over 600,000 prescriptions written in 2015. Data compiled by Bloomberg suggests that fiscal revenue from Belviq prescriptions in 2014 was $49.4 million.
What Should Patients do About the Belviq Recall?
If you take Belviq, Belviq XR or lorcaserin, talk to your doctor about your medication regimen. Your doctor may advise you to take an alternative weight loss medication. If you stop taking Belviq, make sure you dispose of unused products. Locate a drug take back location. If no location is available, dispose of medication by:
- Mixing the pills with something unappealing, such as cat litter, coffee grounds or dirt.
- Place the pills and mixture in a sealed plastic bag.
- Dispose of the bag in your household garbage.
- Remove the prescription label from medication bottles to ensure security of personal information.
- Throw away or recycle plastic medication bottles.
What Should I do if I take Belviq and Have Cancer?
If you take, or have taken Belviq, and now have a cancer diagnosis, you may find it helpful to contact an attorney. At Drug and Device Watch, we can put you in touch with an attorney who is knowledgeable about drug safety, medication recalls and patient rights. If your cancer diagnosis is due to Belviq, you may have an actionable legal claim against the manufacturer. The only way to know for sure is to consult with an attorney about your situation.
Start learning about your legal rights by requesting a free legal consultation. Contact Drug and Device Watch toll free at 1-888-458-6825, or fill out our online form.