The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search instagram avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner
Skip to main content

In February 2020, the U.S. Food and Drug Administration requested the withdrawal of the weight-loss drug, Belviq and Belviq XR (lorcaserin). The administration took this move because a safety clinical trial showed that Belviq could increase the occurrence of cancer.

Manufacturer Eisai Inc. voluntarily removed the drug from the market. Patients were advised to stop taking the medication and talk to their doctors about alternative weight-loss medicines and programs.

Now, many patients are filing individual and class-action lawsuits against the company for failing to make sure Belviq was completely safe before selling it to millions of people.

Study Shows Patients Taking Belviq Had a Slight Increased Risk of Cancer

The FDA first warned about the potential for Belviq to increase the risk of cancer in January 2020, after a preliminary analysis of the study data suggested a possible increased risk.

The administration required the manufacturer to conduct the study as a condition of the drug’s approval in 2012. Called the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients—Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial, it involved 12,000 participants and was conducted between January 2014 and June 2018.

The original goal was to evaluate the risk of heart-related problems in patients taking Belviq, but the primary analysis showed no meaningful difference between the drug and a placebo in the risk of major adverse cardiovascular events. Instead, there was an imbalance in the number of patients with malignancies.

During the course of the trial, 462 (7.7 percent) of patients treated with the drug were diagnosed with cancer compared to 423 (7.1 percent) of those taking placebo. The cancers included pancreatic, colorectal, and lung. The longer the patients took lorcaserin, the more their risk for cancer increased.

Based on these results, the FDA concluded that the risks associated with the drug outweighed the benefits, and requested a recall.

Plaintiffs Filing Belviq Lawsuits to Recover Damages

Since Belviq has been on the market since 2012, thousands of patients have been exposed to it. These patients are now understandably concerned that they may have an increased risk of developing cancer because they took Belviq.

Patients who took lorcaserin for long periods and then were diagnosed with cancer may be eligible to file personal injury lawsuits in an effort to recover damages. But it’s not only those who have been diagnosed who may have a case—those who must now undergo increased medical monitoring to watch for cancer may also have legitimate economic claims.

So far, manufacturer Eisai Inc. seems to have no intention of taking responsibility for Belviq and its potential connection to cancer. The company noted in a press release that it interpreted the results of the CAMELLIA-TIMI 61 trial differently than the FDA: “The Company’s assessment is that Belviq and Belviq XR continue to have a positive benefit-risk profile in the patient population for which they are indicated.”

Comments for this article are closed.