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When Eisai Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for Belviq diet drug in 2012, the introduction of the drug to the market came with one caveat: The FDA ordered Eisai to run post-market studies in an effort to determine whether the diet drug caused heart issues.
This post-market research showed an increased risk of cancer associated with Belviq, the generic version of which is lorcaserin.
Who Is Eisai Pharmaceuticals?
Eisai Pharmaceuticals was started as Nihon Eisai Co. Ltd. in 1941 in Japan. The company was founded by Toyoji Naito, who changed the name to Eisai Co. Ltd. in 1955.
The company now has locations throughout the world, including in the United States, where U.S. subsidiary Eisai Inc. and Arena Pharmaceuticals of California launched Belviq in 2012.
The FDA approved Belviq on June 27, 2012, to be used as a weight-loss diet pill in conjunction with a reduced-calorie diet and increased exercise for patients who have a body mass index (BMI) of 30 or greater. Patients diagnosed with at least one weight-related comorbid condition and had a BMI of 27 or greater also were allowed to receive Belviq. The pill is intended as a long-term treatment to reduce a person’s feelings of hunger in an attempt to encourage weight loss. It works by targeting the brain’s serotonin receptors that affect hunger levels, controlling the person’s feelings of fullness and satisfaction.
At the time, Eisai Belviq was the first prescription weight-loss medication approved in the U.S. in 13 years.
The approval was hailed because the U.S. Centers for Disease Control and Prevention found that more than two-thirds of adults in America are either overweight or obese. With excess weight, people are at an increased risk of a variety of issues, including diabetes, cardiovascular problems, high blood pressure, and cancer.
On Feb. 14, 2020, the FDA called for a recall of Belviq after analyzing research and deciding the cancer risks associated with the weight-loss medication outweighed the benefits.
Are Eisai Products Causing Cancer?
A preliminary review of clinical trial data, according to the FDA, found a possible increased risk of cancer associated with the use of Belviq and Belviq XR, the extended-release version of the drug that was added to the market in Oct. 2016.
In a randomized, double-blind, placebo-controlled clinical trial intended to evaluate any risks Belviq posed to the cardiovascular system, researchers found more patients who were taking Belviq developed cancer compared with those taking a placebo. The trial included 12,000 patients over a span of five years. Although kinds of cancer were reported, the Belviq patients most frequently were diagnosed with pancreatic, colorectal, and lung cancer.
Eisai Pharma called the study the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial.
Held between January 2014 and June 2018 among people in the U.S., Canada, Mexico, the Bahamas, Europe, South America, Australia, and New Zealand, the study looked at 12,000 men and women who were overweight or obese. The study group had to have either an established case of cardiovascular disease or be a minimum of 50 years old for men or 55 years old for women with diabetes plus at least one other cardiovascular risk factor. Patients were randomly provided either Belviq or a placebo that they took twice a day. About 96% of patients completed the entire study.
During the trial, 462 (7.7%) Belviq patients reportedly received a diagnosis of 520 cancers compared with the placebo patients, 423 (7.1%) of whom were diagnosed with 470 cancers.
“There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin,” the FDA’s report said.
Eisai Belviq Side Effects
Like any medication, Belviq is associated with a number of side effects. Side effects of Belviq and Belviq XR may include mild ones such as dry mouth, headache, dizziness, nausea, tiredness, or constipation.
Serious side effects may include the following:
- Easy bleeding
- Easy bruising
- Enlarged breasts
- Abnormal production of breast milk
- Confusion
- Depression
- Suicidal thoughts
- Anxiety
- Memory or attention problems
- Muscle twitches
- Shortness of breath
- Slow, fast or irregular heartbeat
- Swollen ankles, feet or hands
- Fever unattributed to anything else
Patients with diabetes are warned Belviq may increase the risk of low blood sugar. Symptoms include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, and sometimes, tingling of the hands or feet.
An increased risk of cancer — particularly pancreatic, colorectal, and lung cancer — is now a known potential side effect, too.
Eisai Reluctantly Agreed to Withdraw Belviq in the U.S.
Eisai continues to believe both Belviq and Belviq XR “have a positive benefit-risk profile in the patient population for which they are indicated,” according to a statement on the company’s website.
Eisai says it interprets the data of the CAMELLIA-TIMI 61 trial differently than the FDA, but respects the FDA’s decision to withdraw the drug from the market.
The company says most of its medications are developed in-house. Despite the clinical trial of Belviq pointing to an increased risk of cancer, Eisai says it concentrates on the areas of oncology and neurology in its drug development efforts.
Belviq’s FDA Approval History
This is not the first time the Belviq diet pill has run into approval issues with the FDA. In fact, before it was approved back in 2012, it was initially rejected by an FDA panel in a 9-to-5 vote, according to The New York Times. Some committee members were primarily concerned about the safety of the drug, noting tumors had been found in rats exposed to Belviq.
Others were less concerned about these potential side effects and more concerned about the efficacy of the drug, finding it didn’t seem to be particularly effective as a weight loss medication.
“The argument that there is an urgent need I don’t think really mitigates the concern of putting a drug that doesn’t do much and may do harm on the market,” committee member Dr. Pamela S. Douglas, professor of research in cardiovascular diseases at Duke, told The New York Times.
Belviq Litigation
A woman from Hudson Valley, New York, has filed a proposed class action lawsuit against Eisai Pharmaceuticals over allegations the company knew for years that Belviq could increase the risk of certain cancers, according to Westchester and Fairfield County Business Journals.
The lawsuit was filed in March in the U.S. District Court in White Plains, New York, and names two other defendants in the case: Arena Pharmaceuticals Inc., the San Diego pharmaceutical company that developed Belviq’s active ingredient, lorcaserin, and pharmacy chain CVS Health Co. Plaintiff Barbara Z. said she bought Belviq from CVS.
The complaint alleges Arena Pharmaceuticals found lorcaserin was responsible for the development of rare and fast-growing cancerous tumors in rats as far back as 2007. Barbara alleges that if Arena and Eisai would have disclosed the results of the 2007 study to the FDA at that time, the FDA would have prevented Belviq from being available in the U.S.
Barbara’s complaint does not state whether she has been diagnosed with cancer, but does say she is seeking class certification for the lawsuit to include patients throughout the U.S. who took Belviq.
Eisai Inc. and Arena Pharmaceuticals are facing a slew of lawsuits over Belviq cancer. In August 2021, the U.S. Judicial Panel on Multidistrict Litigation ordered that the companies will face lawsuits individually, rather than combining them into the MDL requested by the plaintiffs, per Bloomberg Law.
How to Take Action Against Eisai Pharmaceuticals
Patients who were prescribed Belviq may wish to hold Eisai Pharmaceuticals responsible for side effects suffered due to the use of the weight-loss drug.
Eisai Pharma class action lawsuits can hold the company accountable for allegations related to its purported failure to completely research Belviq’s side effects before placing the drug on the market. Eisai also has been accused of failing to recognize a link between Belviq use and cancer and of delaying the drug’s recall.
Individual wrongful death lawsuits or individual cancer lawsuits may help victims of Eisai’s allegedly false and misleading marketing campaign regarding the safety of weight-loss drug Belviq receive compensation for their losses.
Filing a lawsuit can be a daunting prospect, especially after a cancer diagnosis or the death of a loved one, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.
If you took Belviq or Belviq XR and developed cancer, you may be able to join a FREE Belviq cancer class action lawsuit investigation. Fill out the form on this page for more information.
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