The Belviq lawsuit claims that the use of Belviq can increase the risk of cancer, especially colorectal, pancreatic, and lung cancer.
Our law firm is representing individuals who took Belviq and have suffered any form of cancer. We have been handling lawsuits against drug companies since 1955. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
What Do We Know About the Belviq Lawsuits?
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.
Belviq Clinical Trials & Injuries
In 2012, the FDA approved lorcaserin 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 lorcaserin and those who used the trial’s placebo. However, the analysis revealed a potential connection between lorcaserin and cancer. The analysis mentioned cancer cases in the two trial groups, reporting 215 cases in the lorcaserin group and 210 cases in the placebo group.
Cancer Concerns After Belviq Clinical Trials
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 lorcaserin 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 lorcaserin for one year. Not only did the number of cancers increase, so did the types of cancers that were attached to lorcaserin — 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 lorcaserin, the FDA sounded its alarm.
Compensation in Belviq Lawsuits
We are representing individuals who have suffered cancer as a result of using Belviq. If you or a loved one has experienced cancer, then we will be seeking the following damages for you, whether by jury verdict or settlement:
- Past and future medical expenses that result from your injuries.
- Past and future pain and suffering (physical and mental) caused by the injuries, and the treatment and recovery process.
- Past and future wage loss.
- Past and future loss of earning capacity.
- Past and future loss of enjoyment of life.
- Punitive damages, if appropriate.
Warnings and Recalls Regarding Belviq and Cancer
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.
Types of Cancer Reported to the FDA
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:
- Adenocarcinoma Pancreas
- Basal Cell Carcinoma
- Breast Cancer
- Colon Adenoma
- Endometrial Adenocarcinoma
- Follicular Thyroid Cancer
- Glioblastoma Multiforme
- Hodgkin's Disease
- Intraductal Papillary Breast Neoplasm
- Malignant Melanoma
- Pancreatic Carcinoma Metastatic
- Pancreatic Carcinoma
- Pharyngeal Neoplasm Benign
- Prostate Cancer
- Skin Cancer
- Thyroid Cancer
Belviq Drug Labeling and Cancer
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.
What to Do With Your Belviq/Lorcaserin
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.