After determining a potential link to increased risk of cancer from Belviq FDA officials issued a warning, a voluntary recall and finally a withdrawal of its approval of the weight loss medication.

Belviq, generically known as lorcaserin, was initially hailed as a breakthrough drug to help give the more than 70 million obese Americans a new opportunity to lose weight. According to the Centers for Disease Control and Prevention (CDC), more than 42 percent of U.S. adults were classified as obese in 2018.

A body mass index (BMI) of 30 or more is considered to be obese, while a BMI of 40 or more is considered to be severely obese. The BMI is a calculation based on the weight (kilograms) divided by height (meters squared) and rounded to one decimal place.

Is Belviq a Controlled Substance?

Yes. The U.S. Drug Enforcement Agency uses a scale of one to five, with one being the category for the most strictly controlled substances and five designated for the least controlled drugs, which show very low possibility for drug abuse or drug dependence.

According to these Controlled Substances Act guidelines, Belviq was assigned to Schedule IV, which also includes drugs such as sleep inducer Ambien.

In a clinical trial in Canada, people who took four to six times higher than the recommended 20 milligram daily dose of Belviq began to have some side effects. In people who took a 60 milligram dose, some patients began to experience hallucinations and feelings similar to those in people who have taken LSD. These results helped researchers decide that Belviq was unlikely to be abused.

When Was Belviq FDA Approval Revoked?

The FDA withdrew its approval of Belviq and extended release version of the drug known as Belviq XR on Sept. 17, 2020.

The Belviq FDA approval was withdrawn upon request of Eisai, which waived its opportunity for a hearing.

The withdraw followed an FDA Drug Safety Communication that was issued on Jan. 14, 2019, which warned the public that patients taking Belviq and Belviq XR could experience a possible increased risk of cancer. On Feb. 13, 2020, the FDA asked Eisai to voluntarily remove Belviq and Belviq XR from the market because of clinical trial results indicating the increased cancer risk.

How Does Belviq Work?

The brain has three different serotonin receptors that a drug may influence. These all begin with the designation 5-HT2 but end with A, B or C. Belviq stimulates the 5-HT2C receptor, which helps control the appetite. The 5-HT2C receptor also mediates moods and assists with cognitive abilities.

Hallucinogens such as LSD stimulate a different receptor known as the 5-HT2A.

When fen-phen was a popular weight loss medication combination years ago, the third type of receptor, the 5-HT2B, was stimulated. The fenfluramine (the “fen” part) was linked to the development of heart valve problems, which led to the discontinuation of fen-phen.

At the recommended dose, Belviq’s stimulation of the 5-HT2C receptor was not found to cause hallucinations or heart issues.

Still, Belviq doesn’t only affect the targeted 5-HT2C receptor exclusively 100% of the time. According to researchers from Arena Pharmaceuticals and reported by Forbes, Belviq proved 7.5 times more selective for the 2C receptor when compared with its selectivity of the 2A receptor and was more than 11 times more selective for 2C when compared with its selectivity of 2B.

What Clinical Results Influenced the Belviq FDA Withdrawal as an Approved Drug?

When the FDA approved Belviq in 2012, the regulatory agency required a randomized, double-blind, placebo-controlled clinical trial to be conducted by the drug’s manufacturer. At that time, the FDA wanted to see if patients taking Belviq had an increased risk of cardiovascular issues.

The clinical trial was conducted between January 2014 and June 2018 and included 12,000 men and women who were classified as either obese or overweight. Eisai Pharma called the study the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial.

The CAMELLIA-TIMI 61 trial patients were selected if they had an established case of cardiovascular disease or if they men who were at least 50 years of age or women of at least 55 years of age who had diabetes and at least one additional risk factor for cardiovascular disease.

Patients were randomly provided either a real Belviq pill or a placebo (fake pill) that they had to take twice daily.

Researchers determined that 7.7 percent of Belviq patients were diagnosed with 520 cancers compared with 7.1 percent of placebo patients who were diagnosed with 470 cancers. These results were published in the September 2018 issue of the New England Journal of Medicine.

“There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin,” reported the FDA.

The most commonly diagnosed cancers among the Belviq patients were pancreatic, colorectal or lung cancer, but tumors of other types have been reported, too.

Have Any Belviq Lawsuits Been Filed?

In June, a New York woman filed a Belviq lawsuit alleging the drug caused her to develop thyroid cancer.

Plaintiff Deborah S., now age 52, filed a complaint saying Belviq should have never been made available to patients in the first place because the drug posed unreasonably dangerous side effects. Both Eisai, Inc. and Arena Pharmaceuticals, Inc. are named defendants.

In court papers, Deborah claims she was on a regimen of Belviq from November 2014 through February 2017. Her thyroid cancer diagnosis was made in July 2018.

“Defendants negligently and improperly failed to perform sufficient tests, if any, on humans using Belviq during clinical trials, forcing Plaintiff, and Plaintiff’s physicians, hospitals, and/or the FDA to rely on safety information that applies to other chronic weight management treatments, which does not entirely and/or necessarily apply to Belviq whatsoever,” says the lawsuit.

The Belviq lawsuit also alleges that early studies of the drug on rats and mice found evidence of cancer-inducing activity, but that in at least one of those studies, the tumors were deemed to be caused by increased levels of the hormone prolactin, which was called “a rodent-specific phenomenon.”

The Belviq Lawsuit is Deborah S. v. Eisai, Inc., et al., Case No. 1:20-cv-02608, in the U.S. District Court for the Eastern District of New York.

Join a Belviq Cancer Lawsuit Investigation

If you took Belviq and developed cancer, you may be able to join a Belviq cancer class action lawsuit investigation. 

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