Table of contents
- Latest Belviq Lawsuit Updates
- February 16, 2022: Court Lets Design Defect Claims Proceed
- August 10, 2021: Panel Denies Centralization
- September 17, 2020: FDA Withdraws Approval
- February 13, 2020: Eisai Withdraws Belviq
- January 14, 2020: FDA Warns of Possible Cancer Risk
- What Is Belviq?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Potential Compensation
- Frequently Asked Questions
- Is There a Belviq Lawsuit?
- Why Did the JPML Deny a Belviq MDL?
- What Does the Research Say About Belviq and Cancer?
- Did the Belviq Clinical Study Find Every Cancer Plaintiffs Allege?
- Does Eisai Deny the Belviq Claims?
- How Do I Report a Belviq Side Effect?
Lawsuits allege that Belviq (lorcaserin), a weight-loss drug, caused cancer. The FDA asked Eisai to withdraw the drug on February 13, 2020, after a safety trial showed more cancers in people taking lorcaserin.
The suits name Eisai Inc. and Arena Pharmaceuticals Inc. They allege the makers failed to disclose the cancer risk. As of the August 2021 JPML order, individual injury suits and one putative class action were pending in separate federal courts.
A federal panel refused to centralize the cases on August 10, 2021, so no MDL exists and each case continues on its own.
Latest Belviq Lawsuit Updates
February 16, 2022: Court Lets Design Defect Claims Proceed
The U.S. District Court for the Northern District of New York denied Eisai and Arena dismissal of most claims in a suit by Jennifer Reynolds-Sitzer. She alleges Belviq caused her thyroid cancer, Bloomberg Law reported [1].
Her design-defect claims were adequately pleaded, and her fraud claims were dismissed. The ruling is on a motion to dismiss and is not a finding that Belviq caused cancer.
August 10, 2021: Panel Denies Centralization
The Judicial Panel on Multidistrict Litigation (JPML) denied a request to centralize the Belviq cases, MDL No. 3005. It concluded that “centralization is not the preferable course” [2].
The order described thirteen actions pending in ten districts. Without centralization, the cases proceed separately in federal courts, and each moves on its own schedule.
September 17, 2020: FDA Withdraws Approval
The FDA withdrew approval of the new drug applications for Belviq and Belviq XR. The Federal Register notice says approval was withdrawn as of September 17, 2020 [3].
The notice also says distribution of Belviq into interstate commerce without an approved application is illegal and subject to regulatory action.
February 13, 2020: Eisai Withdraws Belviq
At the FDA’s request, Eisai Inc. announced it would voluntarily withdraw Belviq and Belviq XR from the U.S. market. The FDA Drug Safety Communication said the risks of lorcaserin outweigh its benefits [4].
The FDA said it took this action based on its completed review of results from a randomized clinical trial assessing safety.
January 14, 2020: FDA Warns of Possible Cancer Risk
The FDA alerted the public that a clinical trial showed a possible increased risk of cancer with Belviq and Belviq XR. It said the cause of the cancer is uncertain [5].
The FDA also said it could not conclude that lorcaserin contributes to the cancer risk. The alert covered both the tablet and the extended-release tablet.
What Is Belviq?
Eisai says the FDA approved Belviq in June 2012 for chronic weight management in adults. Those adults had obesity, or overweight with a weight-related condition. The drug launched in the United States in June 2013 [6].
The FDA says lorcaserin works by increasing feelings of fullness so that less food is eaten. It came as a tablet (Belviq) and an extended-release tablet (Belviq XR). The lawsuits on this page concern both.
Who May Be Affected?
People who took Belviq or Belviq XR and were later diagnosed with cancer are the group the lawsuits describe. Plaintiffs in the individual actions allege breast, colorectal, thyroid and parotid gland cancer.
The JPML noted three related actions alleging cancer of the appendix, bladder cancer and ovarian cancer. In the trial the FDA reviewed, pancreatic, colorectal and lung cancers occurred more often with lorcaserin.
Some plaintiffs allegedly took Belviq for as little as a month or two. Others claim to have taken it for several years or more. Only an individual legal review can say whether your Belviq use and diagnosis support a claim.
Reported Injuries or Damages
These are allegations and have not been proven in court. In March 2020, Barbara Zottola filed a putative class action in White Plains, New York, Westfair Business Journal reported [7]. It names Eisai, Arena and CVS Health Co.
The complaint does not say whether she has been diagnosed with cancer. It seeks unspecified damages. It alleges breach of implied warranty, deceptive acts, false advertising, unjust enrichment, fraud and conversion.
The FDA analysis covered the CAMELLIA-TIMI 61 trial. It had about 12,000 participants over 5 years. In it, 462 (7.7 percent) patients taking lorcaserin were diagnosed with cancer, against 423 (7.1 percent) taking placebo.
Recall and Regulatory Background
The FDA advised patients to stop taking lorcaserin. It also advised them to talk to a health care professional about other weight-loss medicines.
Unused pills can go to a drug take-back location. They can also go into household trash mixed with an unappealing substance.
Eisai says its reading of the trial data differs from the FDA’s. Eisai medical information is at esi_medinfo@eisai.com or 1-888-274-2378.
Evidence to Preserve
Keep these records and items together, because they show your Belviq use and your diagnosis:
- Medical records showing the cancer diagnosis and the date it was made
- Pharmacy and prescription records showing Belviq or Belviq XR use, doses and dates
- Pill bottles and packaging, if you still have them
- Insurance and billing records connected to your care
- Photographs related to your condition or the medication
- A timeline of when you started and stopped taking the drug
- Communications with your doctors or the companies
- Any journal or notes on symptoms you kept
Filing Deadlines
Filing deadlines exist and come from state law. They depend on where you live and on when the injury, the illness and the diagnosis happened.
Some states start the clock at diagnosis. A Belviq claim filed after its deadline can end, however strong the facts. Talk with a lawyer soon about the deadline in your state.
Potential Compensation
Depending on the facts, damages in product-liability cases can include medical expenses, lost income, and pain and suffering. In a wrongful-death claim, they can include funeral costs and loss of support.
No Belviq verdict or settlement has been reported. Compensation amounts vary by case. Past results do not guarantee future outcomes. Each person’s records and diagnosis shape any potential compensation.
Frequently Asked Questions
Is There a Belviq Lawsuit?
Yes, there is a Belviq lawsuit. As of August 10, 2021, the JPML described twelve individual personal injury actions and one putative class action. All allege that lorcaserin hydrochloride is a potential carcinogen.
Why Did the JPML Deny a Belviq MDL?
The JPML denied a Belviq MDL because individualized causation issues would predominate. It noted that plaintiffs in over half the actions share counsel. It also noted seven potentially related actions and at most twenty actions in total.
What Does the Research Say About Belviq and Cancer?
The FDA’s review of the CAMELLIA-TIMI 61 trial is central to the research on Belviq and cancer. The FDA is not recommending special screening for patients who have taken lorcaserin after reviewing the trial.
Did the Belviq Clinical Study Find Every Cancer Plaintiffs Allege?
The Belviq clinical study did not find every alleged cancer more often. The JPML noted that it found no increased incidence of six of the seven forms of cancer alleged in the involved cases. That observation does not decide causation.
Does Eisai Deny the Belviq Claims?
Eisai denies the Belviq claims in the Zottola case. It said it intends to vigorously defend against the claim and called the suit without merit. Westfair Business Journal reported those statements on April 15, 2020.
How Do I Report a Belviq Side Effect?
You can report a Belviq side effect to FDA MedWatch by calling 1-800-332-1088. The FDA’s January 14, 2020 alert lists MedWatch under Contact FDA as the place to report a serious problem.