A popular weigh-loss drug has been linked to cancer. Specifically, the FDA requested the withdrawal of Belviq (otherwise known by its generic name of lorcaserin hydrochloride) from the market after determining the drug’s potential risks outweigh its benefits. Now, patients who have developed certain cancers after using the drug are filing lawsuits to hold the drug manufacturer accountable.
Belviq was manufactured by Arena Pharmaceuticals, which was founded in 1997 and has its headquarters in San Diego, California. Eisai Inc. promotes and distributes the drug in the United States. Eisai’s headquarters are in New Jersey. The research and discovery labs are in Massachusetts and Pennsylvania. The global supply chain effort is in Maryland and North Carolina, making it a truly multi-state corporation.
There is now significant evidence that these companies knew or should have known about the carcinogenic effects of Belviq and its generic equivalent. Based on what we now know, our law firm is helping patients with legitimate cases file Belviq lawsuits to hold these companies accountable.
Belviq’s FDA Approval History
Belviq is a serotonin 2C receptor agonist developed by Arena Pharmaceuticals as a weight-loss drug for some overweight/obese adults. To receive a prescription for Belviq, patients must also have at least one other long-term health condition, such as:
- Type 2 (T2) diabetes,
- high blood pressure, or
- high cholesterol.
Belviq affects the chemical signals in the brain that control appetite. The drug makes patients feel fuller and therefore eat less. Doctors prescribe the drug together with diet and exercise for weight loss.
In December 2009, Arena Pharmaceuticals applied to the Food and Drug Administration (FDA) for approval of lorcaserin as a new drug for weight-loss and weight management. The FDA accepted the application in February 2010. The FDA originally said it could not approve the new drug application in its present form because the data showed incidences of cancer in the test lab rats.
In January 2012, Arena Pharmaceuticals responded to the FDA’s denial letter with additional information. In June 2012, Arena Pharmaceuticals received FDA’s approval for 10 mg tablets for use in weight loss in some obese/overweight adults.
In July 2016, Arena Pharmaceuticals announced FDA’s approval for the extended-release form in 20 mg tablets. Arena touted the new pills as a once-a-day treatment to help achieve weight loss instead of twice a day as in the original version. Arena’s announcement also indicated that the safety of both versions, when taken in combination with other prescriptions, over-the-counter products, or herbal products was unknown. The announcement also declared that it was unknown whether either version changed the risk for heart or stroke problems, or death from heart or stroke problems.
Belviq is available by prescription only, as is Belviq XR, the extended-release version. Physicians are warned not to prescribe the drugs to pregnant women, women who expect to become pregnant, or women who breastfeed.
Withdrawal of Belviq from the Marketplace
In February 2020, the FDA requested that Eisai Inc. voluntarily withdraw Belviq due to its potential cancer risk. The request to withdraw the drug was based on the results of a five-year clinical study that Eisai conducted on consumers to ensure that there were no serious cardiovascular effects from the drug. The study was conducted at the request of the FDA at the time of its approval, and the results of that study were reported in the New England Journal of Medicine.
The study consisted of 12,000 consumers in a random, double-blind study, with some taking a placebo. The analysis of the results of the study showed no significant difference with regard to cardiovascular safety between the prescription group and the placebo group. However, the study after five years showed a potential link between Belviq and cancer. FDA subsequently announced that the risks from Belviq use greatly outweigh the benefits after 7.7% of study participants taking the prescription developed cancer, while only 7.1% of people taking the placebo developed cancer. FDA asked Eisai to voluntarily withdraw the drug from the marketplace.
Eisai agreed to withdraw the drug but stated in its announcement that its interpretation of the study data did not agree with the FDA’s interpretation.
What Users of Belviq Should Do Now
The FDA did not mandate any special cancer screening or any other tests. Patients should discuss the recall of Belviq with their doctors. FDA recommends that patients stop taking the drug and talk to their physicians about alternatives for weight loss. The FDA also recommended that doctors stop prescribing the drug and that they contact their patients to tell them the cancer risks involved. The FDA also advised that patients should safely dispose of any unused medicines at their closest drug takeback location.
Consumers who experience any unexpected side effects should report them to the FDA on its adverse events page.
The Kinds of Cancer That Result
The Belviq cases are “emerging,” meaning that there have been no settlements of trials as of yet. Belviq users have reported to the FDA a range of cancer that they have developed. However, the strongest evidence links the following types of cancer to use of Belviq:
- colorectal, and
Serious side effects also result from use in some patients. Some examples are:
- low blood sugar, back pain, coughs with respect to diabetics
- low white blood cell count or anemia
- mood changes
- suicidal thoughts
- changes in heart rate
- swollen breasts and milk discharge
- shaking and twitching, and
- shortness of breath.
The Drug Enforcement Administration lists Belviq as a Schedule IV controlled substance because of the risks for dependence on the drug. When patients take more than the amount prescribed, they can see and hear hallucinations, and both thinking and heartbeat slow down. The drug also adversely interacts with other medicines.
The First Case Filed in New York
About a month after FDA asked Eisai to voluntarily withdraw Belviq from the market, Barbara Zottola filed the first civil lawsuit on March 27, 2020, in the United States District Court for the Southern District of New York. The case is Zottola v. Eisai Inc. et al assigned to Judge Philip M. Halpern. The defendants are Arena Manufacturing, Eisai Inc., and CVS. As of September 15, 2020, the case is in its opening stages with defendants’ and plaintiffs’ counsel briefing defendants’ motions to dismiss.
Zottola claims that Belviq would not have received FDA approval if Eisai had told the FDA about the cancer risks shown in the initial rat study. The lawsuit seeks certification as a class action and requests a trial by jury. The plaintiff’s claims are based on an implied warranty, deceptive acts, false advertising, unjust enrichment, fraud, and conversion. The amount in controversy exceeds $5 million plus court costs and fees.
Our law firm is currently evaluating consumers with injuries for additional product liability lawsuits.
Do You Qualify as a Potential Claimant?
Consumers who developed pancreatic, colorectal, or lung cancer may qualify to file lawsuits if they ingested the product:
- for six months or longer (the six months do not have to be consecutive)
- within seven years before the cancer diagnosis, and
- are over age 18 (Belviq is prescribed only for adults).
In addition, the pancreatic, colorectal, and lung cancer must have started in those organs, not spread to them from somewhere else in the body.
Things Product Liability Attorneys Need to Know to Qualify Consumers as Plaintiffs
If you seek the assistance of an attorney, make sure you provide them with the information below. Our attorneys are familiar with these cases and will make sure to determine whether you are eligible to file a claim against the manufacturers of Belviq:
- if the patient’s primary cancer diagnosis is pancreatic, colorectal, or lung cancer
- how long the patient took Belviq before the doctor diagnosed cancer (at least six months is typical)
- whether the patient was diagnosed with cancer before they were prescribed the drug
- when the patient stopped taking the drug (typically within seven years of diagnosis)
- copies of medical records to provide additional information about the cancer diagnosis, and
- the type of cancer treatment options the physician provided to the patient, what treatment was selected, and whether it is effective.
The Kinds of Damages That Result from Product Liability Lawsuits
Product liability recoveries are awarded to make the plaintiff as whole as possible; that is, as if the injury never happened. While each plaintiff’s lawsuit is unique, a plaintiff in a successful product liability lawsuit may expect to demand the following types of monetary damage award:
- reimbursement for medical expenses that result from your injuries
- compensation for physical and mental pain and suffering
- reimbursement for loss of wages
- compensation for loss of earning capacity
- compensation for loss of life’s enjoyment, and
- punitive damages if the defendant’s behavior was egregious.
What If You Can’t Afford to Hire an Attorney?
It is important that consumers hold corporations responsible for injuries suffered from defective and dangerous products without worry about the cost of litigation. We offer free case evaluations to any clients who calls. Moreover, we only work on a contingency fee. That means that the plaintiffs do not pay for attorney fees until and unless the attorney recovers an award for you in the case. That means that you will never pay us out of pocket; we only earn a percentage of your recovery if we win your case.
Do You Know Someone Who May Have a Belviq Lawsuit?
If you or someone you love has received a cancer diagnosis within seven years of taking Belviq, please contact us for an evaluation of your qualifications as a plaintiff. One of our product liability lawyers will be pleased to assist you. In fact, we invite you to make us your resource for all your legal questions.
Justin is an attorney at Roberts & Roberts and focuses his practice on mass tort litigation, where he specializes in helping individuals who are harmed by recalled or unsafe pharmaceutical drugs and medical devices. He has earned recognition as a “Top 40 Under 40” Trial Lawyer by the National Trial Lawyers. Prior to joining Roberts & Roberts, Justin served as an attorney in all three branches of Texas’s state government, including as a Briefing Attorney on the Texas Supreme Court. He also represented electric and natural gas utilities in complex regulatory proceedings before the Public Utility Commission of Texas and the Railroad Commission of Texas. Justin is a published author in the St. Mary’s Law Journal.