Belviq: FDA Recall, Cancer Risks & Safety Concerns

In 2019, the U.S. Food and Drug Administration (FDA) released a warning that clinical trial data revealed a possible increased cancer risk with Belviq and Belviq XR (the extended-release version of lorcaserin).

The drug’s original maker, Arena Pharmaceuticals, gave Eisai Inc. the rights to develop and market Belviq in 2017. Esai withdrew the drug from the market in 2020 at the FDA’s request due to a potential increased risk of cancer in users. Some people filed Belviq lawsuits claiming it caused them to develop cancer.

While the drug is no longer on the market, understanding Belviq’s recall and safety risks is important if you previously used the drug. If you are interested in Belviq alternatives, you may consider lifestyle changes or other medications, including Saxenda, Wegovy or Zepbound. Surgical options, like bariatric surgery, may also be an option. Consult your doctor to discuss the safest, most sustainable option for you.

Belviq, also known by its active ingredient lorcaserin, is a weight loss medication that the FDA approved in 2012. It’s a tablet taken by mouth to help you lose weight when combined with a reduced-calorie diet and exercise. 

According to data compiled by Bloomberg News, at Belviq’s sales peak in 2015, consumers filled more than 600,000 prescriptions.

How Does Belviq Work?

Belviq’s active ingredient, lorcaserin, works by affecting 5-HT2C serotonin receptors in the central nervous system to reduce your appetite. These 5-HT2C receptors play a role in modulating mood and appetite. 

Some studies have shown that drugs affecting 5-HT2C receptors may have long-term effects on your body’s hormone production. This could lead to issues such as breast tumors, menstrual irregularities and infertility in women. Men may experience decreased fertility and erectile dysfunction.

Eisai issued the Belviq recall because the FDA reviewed post-market clinical trial data showing an increased risk of cancer. The agency requested Eisai withdraw the drug from the market.

“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 said in its February 2020 safety communication.

The FDA advised patients to stop taking Belviq and for health care professionals to stop prescribing the drug. While the agency didn’t recommend cancer screening for people who took Belviq, it encouraged people to talk to their health care provider if they had concerns. 

What Did the Study Find About Belviq and Cancer?

The study requested by the FDA in 2012 revealed higher rates of cancer in Belviq users, including colorectal, lung and pancreatic cancer. According to an article from Harvard Health Publishing, there was a 7.7% increased risk of cancer in lorcaserin users versus 7.1% in the placebo group. 

Researchers analyzed the data in various ways, and the increased cancer risk remained. The FDA said this data confirmed potential cancer findings in previous animal studies conducted before Belviq was approved. 

Based on this information, the FDA determined that the dangers would be too difficult to convey on a label, and further investigation of the risks in a trial would be unethical. The agency requested Eisai pull the drug from the market because it couldn’t be considered safe and effective. 

Another study published in 2021 in Obesity Reviews analyzed study data and found an increased risk of lung and pancreatic cancer but not colon cancer. 

Did Belviq’s Manufacturer Disagree With the Recall?

Eisai disagreed with the FDA’s analysis of Belviq’s safety and the subsequent request to recall the drug. The company issued a statement to the Washington Post saying it believed that Belviq’s benefits outweighed the risks but that it would cooperate with the FDA.

Eisai and Arena Pharmaceuticals faced lawsuits from Belviq users claiming the companies failed to warn the public about the risk of cancer. In 2023, the company reached a global settlement of multiple lawsuits about the weight loss drug. The amount was not publicized. 

Was Belviq Recalled in Europe or Canada?

The European Medicines Agency (EMA) and Health Canada didn’t recall Belviq because the agencies never approved the drug for sale. 

In 2013, the EMA declined to approve the drug, citing “major objections.” The exact objections weren’t disclosed. 

Health Canada was reviewing Eisai’s new drug submission, but the agency asked Eisai additional questions about the data provided. Eisai could not answer the questions and withdrew its application in 2018.

In addition to cancer, Belviq’s warning label lists mood changes, serotonin syndrome and valvular heart disease as other potential side effects.

Mood changes, including depression and suicidal thoughts, are mentioned on the label. You should stop taking Belviq if you experience these symptoms.

If you experience serotonin syndrome, which is when too much serotonin builds up in your body, you should stop taking Belviq and get treatment. Signs of serotonin syndrome include shivering, diarrhea, fever, seizures and muscle rigidity. Serotonin syndrome can be fatal if untreated.

The label also warns that people who develop valvular heart disease symptoms (chest pain, shortness of breath, swollen ankles) while taking Belviq should stop taking the drug or get evaluated for the disease.

If you want to lose weight, your doctor can suggest alternatives to Belviq. Weight loss alternatives include prescription medications, lifestyle changes, supplements and surgery. 

Talk to your medical provider if you previously took Belviq and are concerned about the increased cancer risk. 

FDA-Approved Weight-Loss Medications

FDA-approved weight-loss medications include GLP-1 receptor agonists and appetite suppressants. These weight-loss drugs work by slowing stomach emptying and increasing your feelings of fullness. 

These medications can come with serious side effects, so talk to your doctor about your options so you understand the risks and benefits of each drug.

Ozempic and Mounjaro are Type 2 diabetes medications that aren’t FDA-approved for weight loss, but people sometimes use them off-label to lose weight.

Nonprescription Weight Loss Options

You may prefer a natural or over-the-counter weight loss option. These include lifestyle changes and natural supplements. 

Lifestyle changes: Eat a balanced diet with plenty of fruits and vegetables, lean meats, low-fat dairy and whole grains. Get regular physical activity. Consult with a doctor, nutritionist or another specialist to craft a plan tailored to your needs. 

Weight loss supplements: These include products like pills, liquids, powders or bars that claim to help with weight loss. The National Institutes of Health cautions against these products because many have not been proven effective and may cause harm. Consult your doctor about the risks and benefits. 

Should You Consider Weight Loss Surgery?

Whether you consider weight loss surgery is a decision between you and your doctor. Bariatric surgery is typically for people who cannot lose weight with diet and exercise alone and who have serious health problems related to their weight.

Like all surgeries, bariatric surgery has risks and benefits. Make sure to discuss these with your doctor.