Belviq Cancer Risk
A randomized, double-blind, placebo-controlled clinical trial found that patients taking Belviq (n=462; 7.7%) were more likely to be diagnosed with cancer compared to patients who took a placebo (n=423, 7/1%). A range of different cancer types was reported by the participants, with pancreatic, colorectal cancer, and lung cancer concerns reported most often.
The Food and Drug Administration is petitioning to have Belviq withdrawn because it believes that the Belviq potential cancer link outweighs any potential benefits, based on the agency's review of the trial. Eisai Inc. has submitted a request to voluntarily withdraw Belviq, according to the FDA.
In Jan. 2020, FDA announced that it was reviewing clinical trial data and alerted the public of a potential cancer risk with Belviq  based on a preliminary analysis of the data.
Related Article: Saxenda Weight Loss Medication Lawsuit
What is the Weight-Loss Drug Belviq?
Belviq is a weight-loss medication that is intended to be used together with a healthy diet and regular exercise to treat obesity caused by diabetes, high cholesterol, or elevated blood pressure levels. The FDA approved Belviq on June 27, 2012.
How Does it Work?
Belviq works by altering the brain’s chemical signals responsible for appetite and increasing feelings of fullness to help patients lose weight. Patients taking Belviq are overweight, obese, or suffering weight-related medical problems. Belviq is also sometimes prescribed to treat obesity linked to diabetes, high blood pressure, and high cholesterol, but it does not treat underlying health conditions.
What’s The Difference Between Belviq and Belviq XR?
Belviq is available in 2 separate forms. Belviq is a 10 mg tablet prescribed to be taken twice a day. Belviq XR is an extended-release form of lorcaserin prescribed as one daily dose.
Belviq Side Effects
Potential serious side effects of Belviq may include:
- Lung Cancer
- Colorectal Cancer
- Colon Cancer
- Pancreatic Cancer
- Breast Cancer
- Cardiovascular Events
- Heart Attack
- Heart Valve Damage
- Serotonin Syndrome
Other, less serious Belviq side effects may include:
- Allergic Reactions
- Unusual Thoughts or Behaviors
- Feelings of Extreme Happiness or Sadness
- Feelings of Standing Next to Yourself or Being Outside Your Body
- Thoughts of Suicide or Hurting Yourself
- Memory Loss
- Rapid Heart Rate
- Loss of Coordination
- Stiff Muscles
- Fast or Uneven Heart Beats
- Swelling in the Hands or Feet
- Pale Skin
- Flu Symptoms
- Sores in the Mouth or Throat
- Low Blood Sugar
- Breast Swelling or Nipple Discharge
- Penis Erection Lasting 4 Hours or More
Belviq Safety Study
In September 2020, an analysis of the long-term safety study on Belviq, called CAMELLIA-TIMI, was published in the New England Journal of Medicine (NEJM).
The study found 990 cases of cancer among about 12,000 patients. Approximately 520 of these cases were among Belviq users compared to 470 among nonusers.
While several types of cancers were noted in both groups, the Belviq group saw more patients who developed cancer (20 compared to 8) and cases of metastatic disease (34 compared to 19). More deaths from colorectal cancer occurred in the Belviq group (53 at a median of 3.3 years follow-up compared to 33 in the placebo group).
Three cancers stood out in the study that were of particular concern. Sixteen Belviq users developed pancreatic cancer risk during the study period compared to only two in the placebo group. Belviq users also had nearly twice the number of colorectal cancer than the placebo group, 26 versus 14.
There were also 40 cases of lung cancer among Belviq users compared to 25 among non-users, more cases of leukemia (12 vs 6) and more cases of liver cancer (10 vs 4) in the Belviq group.
“The agency recognizes the importance of weight-loss therapies, but the magnitude of clinical benefit associated with modest weight reduction is uncertain, and this benefit may manifest only after years of sustained weight loss,” the researchers said. “Cancer risk may also be higher among patients using lorcaserin over the long term.”
For example, during the first 180 days of the trial, 76 new cases of cancer were diagnosed in the Belviq group compared to 77 in the placebo group. But when the cancer rate was checked at an interval of every 60 days beginning at day 180 through day 900, cancer diagnoses among Belviq users were consistently above 1.0.
Is Belviq Safe to Take During Pregnancy?
Belviq is classified as a Pregnancy Category X medication, which means that there is evidence of fetal abnormalities based on adverse reaction data. Belviq should only be used by pregnant women when the potential benefits of the drug are greater than its risks, according to the FDA.
Does Belviq Affect Your Memory?
Studies have found that Belviq patients may increase the risk of memory loss, depending on the dosage taken and the length at which they consumed the drug.
Additionally, patients with diabetes who take lorcaserin can also experience back pain, coughing, high blood pressure and hypoglycemia as a result of taking the drug. Lorcaserin can also cause heart valve issues and slowed heartbeat.
The Drug Enforcement Agency classifies Belviq as a Schedule IV controlled substance citing risks of dependence; people who take more than prescribed dosage might experience hallucinations, slowed thinking, and euphoria.
Belviq can also adversely interact with other medications.
The European Medicines Agency also rejected the drug over safety concerns in 2012.
If You Are Taking Belviq
If you are currently taking Belviq, you should discontinue use immediately and talk to your doctor about alternative weight-loss treatments with less severe potential side effects.
Belviq should be disposed of at a drug take-back location, or in household trash using the following steps:
- Mix the medication with an uninviting substance such as dirt, used coffee grounds, or cat litter. Do not crush the pills.
- Place the mixture in a sealed container such as a plastic bag or bottle.
- Throw the container away in your household trash.
- Remove all personal information from the prescription labels on empty medication bottles or packaging. Recycle or throw away the containers.
FDA is not recommending special cancer screening for patients who took Belviq. Patients should still schedule regular recommended cancer screenings and contact their healthcare provider with any questions.
Belviq Class Action Filed in New York
A New York woman who was prescribed the weight-loss drug Belviq has filed a class action lawsuit against Eisai, Inc., alleging that the company knew about the drug's potential to cause pancreatic cancer and other forms of cancer for years, yet failed to adequately warn the public.
The suit seeks damages for alleged breach of implied warranty, deceptive acts, false advertising, unjust enrichment, fraud and conversion. In addition to Eisai, the class action names as defendants Arena Pharmaceuticals Inc., which developed and licensed lorcaserin, and CVS Health Co., the pharmacy where Plaintiff purchased the drug.
Other Resources: Dangerous Drugs Lawsuits
Has There Been a Recall?
The U.S. Food and Drug Administration in February 2020 requested that weight-loss drug Belviq be recalled over cancer concerns. While Eisai Inc. complied with the FDA’s request for removal, a class action lawsuit filed by Plaintiff Barbara Zottola states “by that point, unfortunately, the damage had already been done.”
Concerns regarding the safety of Belviq are not new. The FDA initially rejected an application for approval of lorcaserin “due to safety concerns, specifically cancer risk,” the complaint states.
A study conducted by Arena Pharmaceuticals Inc. in 2007 found that Belviq caused rare and aggressive tumors in rats. Despite these findings, Arena and Eisai resubmitted the application for lorcaserin as Belviq in 2012 and the FDA approved it in 2013 for use by patients with weight-related health conditions.
Concurrently, the FDA required Eisai to conduct long-term clinical trials to assess the increased risk of any cardiovascular side effects associated with Belviq and Belviq XR. However, the drug was already on the market and being prescribed to patients while the study was underway.
FDA subsequently reported that patients in the study who took Belviq were more often diagnosed with cancer than those who took a placebo. Zottola claims that Belviq and Belviq XR never would have been approved if Eisai and Arena told the FDA about the cancer risks identified in the initial clinical trials.
The lawsuit asks the federal court to certify a class of hundreds of thousands of people across the U.S. who purchased Belviq. The lawsuit seeks damages for alleged breach of an implied warranty, deceptive acts, false advertising, unjust enrichment, fraud, and conversion.
Status of Belviq Lawsuits
As the number of Belviq Lawsuits continue to grow, plaintiffs’ lawyers have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the cases into a multidistrict litigation (MDL) in the Eastern District of Louisiana.
MDLs are intended to make handling a large number of cases more efficient, and plaintiffs’ lawyers expect hundreds of people to file Belviq lawsuits.
Defendants in Belviq lawsuits oppose the motion to consolidate cases because they aren’t similar enough and they say there aren’t enough cases to warrant it. They prefer “cooperation and informal coordination between the parties,” according to their response to the motion to transfer filed on May 5, 2021.
To date, there have been no verdicts or major settlements.
Do I Qualify to File a Belviq Lawsuit?
If you took Belviq or Belviq XR and developed cancer or other adverse side effects might be eligible for a Belviq lawsuit seeking compensation for:
- Medical expenses from your treatment
- Pain and suffering, both physical and mental, caused by cancer, treatments, and recovery period
- Loss of wages, loss of earning capacities
- Loss of enjoyment of life resulting from the disease and damages
- Other punitive damages and compensatory damages
The first step to filing a Belviq lawsuit is hiring a personal injury lawyer. Your state’s statute of limitations allows only a certain window of time for you to take legal action after suffering an injury, so it is important to contact a lawyer as soon as possible.
In the unfortunate event that your loved one died as a result of cancer from Belviq, you may need to consult a wrongful death attorney.
Another important first step is to mitigate injuries and future costs by seeking immediate medical treatment and following your doctor’s orders.
Filing a Belviq cancer lawsuit requires the same steps as any other bad drug lawsuit. Familiarize yourself with the steps of the civil litigation process before you begin.
Your Belviq cancer lawyer will help identify liability – who is liable for you or your loved one’s diagnosis.
It’s important to start gathering evidence as soon as possible to support your claim against the manufacturer or liable party. This evidence includes medical bills and proof of damages, loss of wages, and documented physical and emotional suffering.
This will help prove the total cost of losses endured resulting from your diagnosis. In many bad drug lawsuits, the injured party can file for both compensatory damages and punitive damages.
After calculating your total damages, you will determine how much compensation you desire from your Belviq lawsuit to cover your total costs.
Your Belviq cancer lawyer will fight to maximize your compensation, either by settling with the liable party outside of court or moving along into a Belviq lawsuit trial.
Questions You Attorney May Ask
What type of cancer did you develop after taking Belviq?
Most patients who took Belviq and subsequently filed lawsuits were diagnosed with pancreatic, colorectal or lung cancer as their primary cancer.
How long had you been taking Belviq before you were diagnosed with cancer?
Patients had usually been taking Belviq for at least 6 months before their cancer diagnosis.
Had you previously been diagnosed with cancer?
Your attorney will want to know if you had previously been diagnosed with pancreatic, colorectal or lung cancer prior to taking Belviq, as this could put you at an increased risk of developing these cancers again.
When did you last use Belviq?
Individuals filing lawsuits typically had taken Belviq or Belviq XR within 7 years of their cancer diagnosis.
Can you provide a copy of your medical records?
Your Belviq lawyer will want to see copies of your medical records to review any information related to your cancer diagnosis.
What type of cancer treatment are you undergoing?
Be prepared to discuss the cancer treatment options your medical provider had recommended for you and which one you selected. Your attorney will want to know if it’s been effective.
Are you older than 18 years of age?
Belviq is indicated only for use in adults. For this reason, anyone under the age of 18 who took Belviq will likely not be eligible to file a lawsuit.
When did your loved one pass away from cancer?
If you’re seeking to file a lawsuit on behalf of a family member who died from cancer caused by Belviq, it’s important to act quickly. People filing lawsuits generally contact an attorney within a year and half of their loved one’s passing.
Do I Have a Belviq Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Belviq lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one got cancer after taking Belviq, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.