On February 13, 2020, the U.S. Food and Drug Administration (FDA) announced that the drug manufacturer, Eisai Inc., has agreed to voluntarily withdraw its weight-loss drugs Belviq (lorcaserin) and the extended-release version, Belviq XR, from the market and discontinue sales after a clinical trial revealed an increased risk of cancer from Belviq use.
What Should Patients Do?
The FDA is not recommending additional screening for patients who have taken Belviq at this time, but patients should stop taking Belviq and consult with their health care provider about alternative weight-loss medicines and programs.
No-Cost Belviq Lawsuit Consultations
The Belviq lawyers at Cutter Law P.C. are reviewing potential lawsuits on behalf of former users of the drug who have since been diagnosed with Pancreatic cancer, Colorectal Cancer, Lung Cancer, or another cancer afflicting the digestive tract.
Belviq Recall Lawsuits
Our Belviq attorneys are specialized in dangerous drugs and are currently reviewing potential Belviq lawsuits and Belviq class action lawsuits.
The manufacturer of this weight loss drug has a moral and legal responsibility to research and present all of the potential risks. Allegations that will be against the manufacturer include:
- Failure to research the side effects of Belviq / Belviq XR before introducing this drug to the market
- Failure to follow up on studies related to Belviq cancer risks
- Ignored evidence linking Belviq and cancer
- Provided false or misleading statements about the safety of Belviq
- Deferred consumer safety to their desire for profits
- Delayed issuing a Belviq recall
- Continued sale of Belviq, despite the associated health risks
Belviq & Belviq XR Cancer Overview
What is Belviq?
Belviq (lorcaserin), developed by Arena Pharmaceuticals, is a weight-loss drug for those who are obese or have weight-related medical problems and are unable to lose weight through diet and exercise programs alone.
Belviq works by manipulating brain chemicals (specifically, serotonin levels) to reduce appetite, giving the user the feeling of being full.
On February 13, 2020, nearly seven years after the drug was released to the U.S. market, the FDA issued a statement requesting the withdrawal of the weight-loss drug due to increased risk of cancer.
When Was Belviq Approved by the FDA?
The drug was officially approved by the FDA in 2012 as a weight-loss drug, and was available in the U.S. markets a year later, in June 2013. In 2012, Belviq was the first obesity drug to be approved in 13 years.
However, even before the drug was introduced, there were concerns regarding the safety of the drug.
FDA Rejected Belviq Approval in 2010
In October of 2010, the FDA rejected the new drug application (NDA) approval of Belviq, for both clinical and non-clinical issues with the NDA. The FDA’s complete response letter (CRL) states there was an unclear safety margin for lorcaserin-emergent brain astrocytoma, and that additional clinical studies may be required to obtain a more complete assessment of lorcaserin’s benefit-risk profile.
Arena complies with the requirements of the FDA, and submitted a complete response letter in January 2012, which states increased tumors in rats would not affect humans.
Belviq Receives FDA Approval in 2012
The FDA voted 18-4 to approve Belviq in June 2012 but required the manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems, due to similar weight-loss drugs which were linked to cardiovascular issues (Fen-Phen and Redux were recalled in 1997).
This trial is known as the “CAMELLIA-TIMI 61” trial.
Clinical Trial Results of CAMELLIA-TIMI 61
The CAMELLIA-TIMI 61 trial was a 5-year, double-blind, placebo-controlled study of 12,000 patients in 8 countries.
The trials’ purpose was to determine the amount of risk to cardiovascular health, since, in 1997, the similar weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that these drugs caused heart valve damage, assumed to be related to activation of the serotonin 2B receptor on heart tissue.
The trial concludes that with 10 milligrams doses, twice a day, Belviq does not appear to activate the serotonin 2B receptor.
The trial results did not account for increased risk of cancer since the study was required in order to affirm cardiovascular health would not be affected.
Belviq lawyers correctly acknowledge that users may have avoided cancer if the drug manufacturer had adequately researched the side effects of Belviq and warned about the risk of cancer, which should have been diligently researched in 2010 – especially after the FDA first rejected the new drug application for Belviq due to inadequate data to confirm the drug would not increase risk of cancer.
Belviq Cancer Risk
On January 14, 2020, the FDA made an announcement alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer.
Although the initial trial indicated the drug was safe to use, over the long-term, it found that more patients taking lorcaserin (462; 7.7 percent) were diagnosed with cancer compared to those taking a placebo, which is an inactive treatment (423; 7.1 percent).
Belviq Recall: February 2020
Less than a month later, on February 13, 2020, the FDA announced that the drugmaker has agreed to withdraw Belviq from the U.S. market. The manufacturer of the drug has agreed to stop sales of the drug. Belviq wrongful death claims, Belviq lawsuits, and Belviq recall class actions are currently being investigated.
The most common types of cancers specifically linked with the drug are Pancreatic Cancer, Colorectal Cancer, and Lung Cancer, among others.
Finding A Knowledgeable Belviq Attorney
Cutter Law P.C. is a firm that has extensive experience with dangerous drugs, product liability, wrongful death, and class action lawsuits.
Our Belviq attorneys are well-versed in how Belviq works, side-effects, and know-how to hold the manufacturer liable for their negligence.
Though damages due to these drugs can never be erased, we’ve successfully represented thousands of clients affected by dangerous drugs and helped them receive settlement fair compensation.