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The Belviq lawsuits claim that the use of Belviq can increase the risk of cancer, especially colorectal, pancreatic, and lung cancer.
Our law firm is no longer accepting Belviq injury cases.
Belviq (lorcaserin hydrochloride) was originally developed by San Diego-based Arena Pharmaceuticals, Inc. The drug is a serotonin 2C receptor agonist for weight management marketed as a medication for adults who are obese and suffer from a weight-related condition, like type 2 diabetes, high blood pressure, or high cholesterol.
On February 13, 2020, the U.S. Food & Drug Administration (FDA) announced that it had requested the voluntary recall of Belviq and Belviq XR from the market. The FDA’s Drug Safety Communication warned of an increased occurrence of cancer in a long-running clinical trial of the drugs. Based on these studies, the FDA concluded that the risks of Belviq outweigh its benefits.
This announcement came approximately one month after the FDA had issued an alert about the possible carcinogenic nature of the medication, also known as lorcaserin.
In 2012, the FDA approved Belviq with the requirement that drug manufacturer Eisai conduct clinical trials about the risk of cardiovascular problems associated with its weight-loss medication. Over the course of five years, 12,000 obese patients with various cardiovascular disease risk factors participated in a randomized, double-blind, placebo-controlled clinical trial.
The analysis that followed the trials was published in 2018. It indicated no meaningful difference in cardiovascular safety between groups who used Belviq and those who used the trial’s placebo. However, the analysis revealed a potential connection between Belviq and cancer. The analysis mentioned cancer cases in the two trial groups, reporting 215 cases in the Belviq group and 210 cases in the placebo group.
In the 18-month period after the 2018 analysis was released, the FDA determined that the clinical trial participants continued to experience an increase in cancer diagnoses—247 patients in the Belviq group and 213 patients in the placebo group.
Of the trial participants who took the weight-loss medication, 462 (7.7 percent) were diagnosed with 520 cancers, as compared with 423 (7.1 percent) placebo patients being diagnosed with 470 cancers. One additional cancer manifested for every 470 patients treated with Belviq for one year. Not only did the number of cancers increase, so did the types of cancers that were attached to Belviq — with higher incidents of colorectal, pancreatic, and lung cancer diagnoses among the medication’s users.
Prompted by this data and noting that these imbalances of cancer diagnoses increased with the amount of time that patients were taking Belviq, the FDA sounded its alarm.
As of December 10, 2021, there have been no large groups of mass torts settlements involving Belviq and the link to cancer. However, litigation likes this generally takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (known as an MDL).
In 2010, the FDA denied the original New Drug Application (NDA) for Belviq, in part because of some early red flags about potential cancer risks noted in preclinical rat studies. An October 2010 Complete Response Letter detailed the FDA’s concerns about a few observed conditions in rats that were administered lorcaserin: a large number of mammary tumor-related deaths and cancerous masses that metastasized to the lungs of female rats; and an increase in the incidence of a certain type of brain tumor in male rats.
The FDA’s letter also commented on poor documentation, pathology errors, and withholding of rat study data, all of which was referred to as “questionable conduct” on behalf of Arena.
Arena eventually resolved these issues and gave adequate assurance to the FDA regarding Belviq’s safety margins related to the observed cancers. The FDA approved Belviq in June 2012, then approved an extended release formulation, Belviq XR, in July 2016. The FDA has not approved any generic formulations of lorcaserin hydrochloride.
In February 2020, the FDA requested the recall of Belviq and Belviq XR from the market as a result of its potential cancer link.
As of March 16, 2020, only eight patients had submitted adverse reports to the FDA’s Adverse Event Reporting System (FAERS), a database containing information about medication errors and adverse events.
These patients reported 15 types of cancer:
Under most state laws, a patient injured through the use of a defective drug can bring a lawsuit based on the following legal theories:
All states enforce a statute of limitations that limits the amount of time you have to file a lawsuit against a drug manufacturer. A member of our legal team can inform you of your state’s laws.
Product labeling for Belviq includes warnings about greater decreases in white and red blood cell counts (referred to as hematological changes) when comparing lorcaserin vs. placebo test groups. The label also refers to elevation in prolactin, a protein connected with enabling the production of milk.
Although the medication’s label does present some data from the rat cancer studies, the product label does not feature any warnings about the heightened risk of cancer.
The FDA urges patients to stop taking Belviq/lorcaserin and dispose of unused portions via a drug take back location. If such a location is not accessible, patients can dispose of the medication in their trash by mixing it with cat litter, dirt, used coffee grounds or some other “unappealing substance.” The mixture should be sealed in a plastic bag, then thrown away in the patient’s home trash. The agency is not recommending special screening for individuals who have taken this medication, but they do suggest speaking with a healthcare professional about any questions or concerns.
The Japanese drug maker Eisai on Thursday said it would withdraw the weight-loss drug Belviq from the U.S. market after the Food and Drug Administration expressed concerns about an increased occurrence of cancer reported in people who used the product. The agency recommended that people using Belviq to lose weight should stop taking the medicine immediately, although the FDA is not recommending special cancer screening for people who have used the drug. Reported in STAT
Belviq is thought to trigger chemical signals that make people want to eat less. But early studies, done in rats, gave hints that it might also cause cancer. Since Belviq was approved, researchers have been conducting a five-year-long study to look at the drug’s safety profile. The FDA said Thursday that those higher risks were significant enough for the agency to take the rare step of calling for the drug’s removal. About 7.7 percent of Belviq patients had cancer diagnoses, compared with 7.1 percent of patients who got a placebo.Reported in Washington Post
The FDA said in its announcement that, when approving Belviq, the agency required the drug manufacturer, Eisai Inc., to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In the trial, conducted in about 12,000 participants over five years, more patients taking Belviq were diagnosed with cancer compared to patients taking a placebo. Reported in CNN
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