In February 2020, the U.S. Food and Drug Administration (FDA) announced a recall of prescription weight loss drug Belviq after finding its side effects may include an increased risk of cancer.

The recall was a step up from the FDA’s January 2020 Drug Safety Communication that said the federal regulator was taking a closer look at data from a safety clinical trial.

Belviq Recall Over Cancer Risk

The FDA requested a voluntary recall of lorcaserin in mid-February, after the safety clinical trial found an increased occurrence of cancer.

The FDA required the drug manufacturer to conduct a clinical trial to evaluate the risk of cardiovascular issues among users, but found more patients on Belviq were diagnosed with cancer compared to the group that was taking a placebo (7.7 percent versus 7.1 percent). Many types of cancer were reported, but pancreatic cancer, colorectal cancer, and lung cancer are reportedly those most often seen among Belviq patients.

The clinical trial, known as CAMELLIA-TIMI 61 (Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61), was conducted between January 2014 and June 2018 and examined 12,000 male and female patients.

The FDA said there was no apparent difference in incidence of cancer during the initial months of a patient’s treatment; however, the imbalance increased the longer the patient was on lorcaserin.

Though the observed cancer risk in the clinical trial was low, FDA reviewers found it was still was too great compared to the drug’s relatively modest benefits.

“[O]ur review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment,” Janet Woodcock director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The company has submitted a request to voluntarily withdraw the drug.”

The FDA said health care professionals should stop prescribing Belviq and advised patients to stop using Belviq and talk to their health care providers about other weight-loss options.

“We will continue to track safety issues with medications on the market and use science and data as our guide to act quickly when we have determined that the risks associated with drugs are greater than the benefits of treatment,” Woodcock said.

The group analyzing the safety data admitted they could not be certain lorcaserin use is linked with higher instances of cancer.

What Is Belviq?

Belviq is a weight-loss drug made by pharmaceutical company Eisai Inc.

Generically known as lorcaserin, Belviq was approved by the FDA in the summer of 2012 to help people lose weight. At the time, Belviq was made by Arena Pharmaceuticals, which heralded the drug as the first prescription weight-loss medication to receive FDA approval in 13 years, according to WebMD.

Belviq was FDA approved in 2012 even though the federal regulating agency originally declined to approve the drug in 2010 because of safety and effectiveness concerns.

Starting in late June 2012, adults with a body mass index (BMI) of more than 30 and who were considered obese were able to receive Belviq, as were adults with a BMI of 27 or higher if they also suffered from high cholesterol, high blood pressure, or type 2 diabetes.

Is It Safe to Use Belviq for Weight Loss?

In the FDA Drug Safety Communication issued Feb. 13, 2020, the regulator said it believes the risks of the drug outweigh the benefits now that the FDA has completed a review of a randomized clinical trial.

Belviq and its extended released version, Belviq XR, have been recalled from the market, per the FDA’s direction.

Though the FDA has requested a voluntary recall on Belviq and its maker has obliged, the company stands behind its drug, maintaining Belviq is safe.

The marketing for Belviq touted many possible advantages for patients, and it looked like a promising new drug when it appeared on the market, according to ABC News. Belviq was introduced among multiple other weight-loss drugs after a dry spell in the production of new weight-loss drugs. 

Belviq seemed like a good option because it came with fewer side effects than other available competitors.

For instance, weight-loss drug Contrave, approved in 2014, came with a warning the drug may be linked to an increased risk of experiencing suicidal thoughts, and even an increased risk in suicide attempts, ABC News reported.

Belviq also seemed like a better alternative to diet drugs that had been on the market much longer.

Older diet drugs were reportedly removed from the market also because of their increased risk of suicidal thoughts, as well as the possibility of damage to the heart’s valves, according to ABC News.

One drug released around the same time as Belviq, Qsymia, did yield more weight loss than Belviq. It was also significantly cheaper than Belviq.

However, information about Belviq presented it as relatively positive when it was introduced.

The FDA has recommended that patients who have a supply of Belviq dispose of the medication either by returning the drug to the point of sale or the manufacturer or by destroying it by mixing the pills with dirt, cat litter, or coffee grounds and throwing them away in a sealed bag after removing all personal information from the medication’s label.

What Are Belviq’s Side Effects?

Common Belviq complaints include nausea, headache, dry mouth, dizziness, and constipation, according to WebMD. Some patients also might feel tired.

In patients with diabetes, Belviq may increase the risk of low blood sugar.

Some patients suffer serious side effects, including enlarged breasts or breast milk production, mood changes (including potential thoughts of suicide), shortness of breath, an irregular heartbeat, or unexplained fever, according to WebMD.

Other potential negative side effects of Belviq reported by patients include upper respiratory infections or coughs, muscle or back pain, sore throat, nasal problems, vomiting, rashes, urinary tract infections, and painful erections.

As with other drugs, the potential increased risk of cancer has just recently been discovered as a possible Belviq side effect.

Belviq Cancer Lawsuits

According to one woman who took the weight-loss drug, the manufacturer may have known of the potential risks for years, and still allowed the medication to remain on the market.

In her lawsuit, she claims the drug maker may have pushed the medication to market despite insufficient testing and evidence that it may cause negative health side effects, according to Westfair Online. The plaintiff is suing for compensation for false advertising and breach of implied warranty and alleges fraud and deceptive acts.

One reason plaintiffs may suspect the manufacturer’s motives might place profits over their health is the cost of the drug. Belviq costs approximately $300 per month and is not covered by most insurance plans, according to Westfair Online.

Filing a Belviq Cancer Lawsuit

When patients were prescribed Belviq, they had no way of knowing they could face a greater risk of cancer.

The potential link between Belviq and cancer means patients who have suffered from any type of cancer diagnosis after taking the medication could qualify to participate in a Belviq cancer class action lawsuit investigation.

If you took Belviq or Belviq XR and developed cancer, you may be able to join a FREE Belviq cancer class action lawsuit investigation. Fill out the form on this page for more information.

Get a Free Case Evaluation