Belviq is the market name for the drug, lorcaserin, an oral medication that was commonly prescribed for weight-loss and to combat obesity. Part of a family of drugs known as “5-HT2c agonists”, Belviq acts as a receptor compound in the human central nervous system. It triggers the release of hormones that suppress appetite by giving users the sensation of “fullness”.
Belviq and Belviq XR were, until recently, available as prescription medication. On February 13, 2020, both versions of the drug were voluntarily recalled by manufacturer Eisai, Inc., after consultation with the U.S. Food and Drug Administration (FDA). The FDA took action to remove Belviq from the market after postmarket evaluations and clinical trials revealed an increased occurrence of cancer.
A month after the FDA recall, Barbara Zottola of White Plains, New York, became the first person to file a lawsuit naming Eisai, Inc. and drug developer Arena Pharmaceuticals alleging that they knew the drug was linked to cancer and hid that information from both the FDA and the public. That class-action lawsuit is currently pending before the federal court for the Southern District of New York.
Prescription Name and Overview
Belviq and Belviq XR (extended-release tablets) are the brand names for the medication lorcaserin, a weight loss medication approved by the FDA in 2012. It was typically prescribed as a tool to assist adults with weight-related medical issues or obesity to lose weight and keep it off (in combination with a low-calorie diet). Belviq is classified as a “serotonin receptor agonist” which works by interacting with hormones in the central nervous system to make users feel like they have eaten to fulfillment.
Belviq was originally developed by Arena Pharmaceuticals, Inc. which initially submitted the drug for approval by the FDA in 2010. The agency withheld approval at that time due to concerns specifically related to “cancer risk” in addition to questions as to whether or not the drug had any benefit to patients. Undeterred, Arena and Eisai jointly resubmitted Belviq for approval in 2012 and the FDA approved it for use in patients with weight-related conditions in 2013. The FDA’s approval was conditioned upon Eisai’s agreement to conduct long-term clinical studies to assess risks from heart and attack and strokes. These studies were equivocal concerning heart risks. However, they did evidence an increase in cancer diagnoses, and in February 2020, after consultation with the FDA, Eisai voluntarily withdrew Belviq from the market.
Generic Name and Overview
Lorcaserin (marketed as Belviq and Belviq XR).
OTC Name and Overview
Manufacturer
Belviq and Belviq XR (lorcaserin)
Eisai, Inc.
Tokyo, Japan (Global Headquarters
Woodcliff Lake, New Jersey (U.S. Subsidiary)
Drug Development
Arena Pharmaceuticals, Inc.
San Diego, California
Labeled Indications
Belviq is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese); or 27 kg/m2 or greater (overweight); in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
Dosages:
One tablet (10mg) twice daily. Use of Belviq should be discontinued if 5% weight-loss is not achieved by week 12.
What Is It Used For?
Belviq was prescribed as a way to help adult patients suffering with obesity or other weight-associated ailments to lose weight and keep from re-gaining it. A prescription for Belviq was commonly intended for use with a lower calorie diet and healthy activity plan.
How Does it Work?
Belviq acts to address 5HT2c receptors in the human central nervous system (in particular the hypothalamus) by stimulating the production and release of hormones (alpha-melocnocortin-stimulating hormone) to suppress appetite. It is taken orally and is rapidly absorbed through the gastrointestinal tract.
What are the Approved Uses?
Belviq was initially approved as a long-term aid to promote weight loss in obese or overweight patients. It has since been recalled from the market.
Production Anecdotes / History
The New Drug Application for Belviq was first submitted to the FDA in 2009 by the drug’s developer, Arena Pharmaceuticals, as a candidate drug for assistance with weight management and weight loss. In September 2010, an FDA Advisory Panel voted 9-5 to deny approval of Belviq on the basis of concerns stemming from studies that indicated tumor growth in rats; as well as uncertainty over whether Belviq actually achieved the weight control results in its manufacturer touted.
Arena resubmitted the application for Belviq in 2012 along with additional studies and research. The FDA panel reviewing the application then voted to approve Belviq for weight control with the condition that the manufacturer restricts its use and conduct additional monitoring of patients. Specifically, the FDA approved the use of Belviq in adults with a Body Mass Index (BMI) greater than 30 (obese) or with a BMI greater than 27 and accompanying conditions such as high blood pressure or type-2 diabetes.
International pharmaceutical manufacturer, Eisai, Inc. purchased the global rights to develop and market Belviq in 2017.
Precautions
Pregnancy
Belviq is classified by the FDA as a “Pregnancy Category X” due to the risk of weight loss during pregnancy and fetal harm which could result. Women who become pregnant while taking Belviq should immediately consult their physician to be properly apprised of the risks to themselves and the fetus.
Other Precautions
Belviq may trigger conditions associated with Serotonin Syndrome/Neuroleptic Malignant Syndrome in conjunction with other medications. Patients should consult physicians if they develop:
- Fever
- Confusion
- Mental Changes
- Restlessness
- Fast Heartbeat
- Muscle Spasms
- Trouble Walking
- Nausea
- Vomiting
- Diarrhea
Belviq patients should also be monitored for suicidal thoughts, depression, or other psychiatric disorders such as euphoria or dissociation.
The use of antidiabetic medications with Belviq may cause issues with blood sugar and cause hypoglycemia. Glucose levels should be monitored.
Priapism (erections which last four hours or more) can be a symptom of Belviq use.
Long-Term Use Considerations
Aside from the issues involving cancer and the potential for tumor growth identified in the Belviq recall notice, the most common reactions to Belviq (in non-diabetic patients) are headache, dizziness, fatigue, nausea, dry mouth, and constipation. Diabetic patients have been documented with reactions such as hypoglycemia; headache, back pain, cough, and fatigue.
Controlled Substance Classification
Belviq is listed as a Controlled Substance on Schedule IV of the Controlled Substances Act. In studies, Belviq has been shown to produce substantial episodes of euphoric “highs”, hallucinations or sedation. Accordingly, the ability to produce these effects suggests that Belviq also has the propensity to induce psychic dependence.
Drug Interactions
Belviq has been observed to have negative reactions when taken with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, St. John’s Wort.
Long-Term Side Effects
Long term side effects from use of Belviq are not well documented.
FDA Warnings (History Of)
On February 13, 2020, the FDA issued a “Drug Safety Communication” requesting the withdrawal of Belviq and Belviq XR from the U.S. market on the basis of clinical trials which indicated an increased occurrence of cancer from taking the drug. Belviq’s manufacturer, Eisai, Inc. voluntarily withdrew the drug following the communication.
The FDA’s communication came following years of randomized, double-blind, placebo-controlled clinical trials that were a condition of Belviq’s approval in 2012. These trials were instituted to look for risks associated with cardiovascular problems. They involved 12,000 patients over 5 years and instead uncovered several types of cancers which were reported more frequently, including:
- Pancreatic
- Colorectal
- Lung
Other Common Side Effects
Taking Belviq may involve the experience of serious side effects, including – but not limited to:
- Unusual changes in mood or behavior
- Thoughts of hurting yourself
- Dry eyes
- Blurred vision
- Feelings of standing next to yourself
- Memory problems
- Trouble concentrating
- Breast swelling
- Confusion
- Nipple discharge
- Penis erection that is painful or lasts longer than 4 hours
- Fast or uneven heartbeats
- Trouble breathing
- Dizziness
- Ongoing weakness
- Swelling in your arms, hands, legs, or feet
- Agitation
- Sweating
- Hallucinations
- Fever
- Overactive reflexes
- Nausea
- Vomiting
- Diarrhea
- Loss of coordination
- Fainting
- Very stiff (rigid) muscles
- High fever
- Tremors
- Lightheadedness
If a person has serious side effects and feel life threatening the doctor should be called right away.
Lawsuits
Following the FDA’s recall of Belviq in February 2020, a lawsuit was filed in federal court in the Southern District of New York by Barbara Zottola seeking designation as a class action against both Eisai, Inc. and Arena Pharmaceuticals. Ms. Zottola was prescribed Belviq and used the drug on regular occasions over a period of at least two years.
The complaint alleges that as far back as 2007, Arena undertook long-term tests in rats to determine the cancer risk from Belviq and that those tests, early on, indicated that Belviq was causing rare tumors. Furthermore, Ms. Zottola asserts that had Arena and Eisai been more forthright about the cancer risks as they understood them, that the FDA would not have permitted Belviq onto the market.
Sources Cited (14)
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
