On Feb. 13 the U.S. Food and Drug Administration (FDA) requested that the manufacturer of weight-loss drug Belviq (lorcaserin hydrochloride) recall the drug because studies have shown increased cancer occurrence in those taking it. The FDA stated that it believes the risks of Belviq outweigh the potential benefits. The withdrawal request applies to Belviq and Belviq XR (extended release).
Belviq manufacturer Eisai has acceded to the FDA request and is voluntarily withdrawing Belviq and Belviq XR from the market.
“Based on the change in FDA’s risk-benefit assessment and as requested by the agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market. Eisai respects the FDA’s decision and is working closely with the agency on the withdrawal process,” the company stated in a press release.
Patients are advised to stop taking Belviq and to consult with their healthcare providers about alternative weight loss treatments and weight management programs.
Healthcare providers are advised to stop prescribing and dispensing Belviq and to alert patients that have been taking Belviq of the increased cancer risk. While the FDA is not recommending any special cancer screenings for Belviq patients, the agency said that standard cancer screening protocols should be followed.
In a randomized placebo-controlled clinical trial, the FDA found that more patients who took Belviq were diagnosed with cancer than those who took a placebo. There wasn’t one sole type of cancer that occurred —pancreatic, colorectal and lung were among the types of cancer found in the patients.
The FDA has advised people who have Belviq tablets to dispose of them safely at a drug take back location. If unable to do that, the FDA offers the following drug disposal guidance:
- Mix Belviq tablets with an unappealing substance such as dirt, but without crushing the tablets.
- Seal this mixture into a secured plastic bag or box.
- Throw the sealed mixture into the trash.
- Make sure to remove all personal information when disposing of the drug.
This action follows a Jan. 14 FDA drug safety communication alerting the public of a possible increased risk of cancer associated with Belviq based on a preliminary data analysis. At the time, the FDA stated that while it wasn’t clear that Belviq was the cause of the increased cancers, the agency wanted to inform the public of a potential risk and would continue its investigations.
According to MedPage Today, the FDA approved Belviq in 2012 for people with a body mass index of 30 or more, or a BMI of 27 with obesity-related co-occurring conditions such as diabetes. After an initial application was rejected, a second application was approved, although the FDA expressed concern about associated heart valve issues.
The medication decreases appetite to help patients avoid overeating. Serotonin 2C is activated in the brain, which helps the person eat less and feel more full after eating. Nevertheless, the results of the prescription weren’t revolutionary. During the clinical trials, the lorcaserin group and the placebo group had a small weight loss difference — only 3.3 percent.
For now, medical professionals should cease all prescriptions for this drug. If you have taken lorcaserin, please talk to your medical professional.