01

How Belviq Works

Belviq, also known by its drug name lorcaserin, is a weight loss aid designed to reduce feelings of hunger in overweight and obese individuals. The medication works by activating the serotonin receptors in the brain that affect a person’s appetite. Belviq was available in two formulations: Belviq—taken twice a day—and Belviq XR—taken once a day.

Use of Belviq was intended to accompany a low-calorie diet and doctor-supervised evaluation of weight loss. Patients who did not lose at least 5% of their body weight during the first 12 weeks on Belviq were generally not considered good candidates for continued use of the medication.

02

Belviq’s Unusual Approval Process

Belviq was initially developed by Eisai, Inc., a Japanese pharmaceutical company—making its path to FDA approval atypical. Drugs developed in other countries can receive U.S. approval without additional clinical trials. In these scenarios, FDA officials review the information gathered from the drug’s development in its home country to inform their decision.

Eisai first asked the FDA to approve the medication’s sale in the US in 2009. However, the application was rejected when a majority of review panel participants agreed that its dangerous side effects outweighed its usefulness as a weight loss aid.

Following this rejection, Arena Pharmaceuticals, an American company, stepped in to conduct additional testing and resubmit the application for Belviq’s approval in 2012. The FDA approved this second request but added certain monitoring requirements and restrictions. One such restriction was limiting Belviq candidates to those patients who either met the criteria for obesity or overweight status and had at least one related condition, such as diabetes or hypertension.

Another monitoring requirement for Belviq’s approval was conducting an additional trial into the drug’s impact on cardiovascular health. This ongoing testing ultimately uncovered the drug’s links to cancer and led to its FDA-sanctioned demise.

03

Belviq Side Effects

Initially, the side effects associated with Belviq appeared to be minor. According to the medication’s package insert, only 11 side effects were reported by more than 5% of users who tried Belviq during clinical trials.

Certain other potentially serious side effects were reported, including an increased risk of serotonin syndrome in patients who took Belviq with other serotonin-acting medications, including SSRIs used to treat depression. The package insert listed several such symptoms with the advice to seek immediate medical attention if they occurred. None of the listed symptoms, however, included cancer.

Additional Side Effects for Patients Without Diabetes

For patients without diabetes, the most common reported side effects included, constipation, dizziness, dry mouth, fatigue, headache, and nausea.

Additional Side Effects for Patients With Diabetes

Patients with diabetes were more likely to report hypoglycemia, cough, and back pain.

04

Research Links Belviq to Cancer

The FDA’s request that Eisai, Inc. take Belviq off the market was spurred by the results of the five-year study of Belviq patients. The research indicated that these patients were more likely to develop various types of cancer than similarly-situated patients who did not take Belviq.

The study followed 12,000 patients, some of whom took Belviq and some of whom took a placebo. The resulting data revealed that cancer developed in 7.7% of patients taking Belviq and in 7.1% of patients taking the placebo. Three specific types of cancer—pancreatic, colorectal, and lung cancer—were more likely to occur in the group of patients taking Belviq than in the group taking the placebo.

The FDA recommended that patients stop taking Belviq immediately and talk to their doctors about alternative options for weight management. The FDA also provided guidelines for disposing of unused medication in a safe manner.

Get the insights you need to strengthen your Belviq case.

05

Assessing Damages Caused by Belviq

Assessing both compensatory and punitive damages for Belviq patients will require careful evaluation of each patient’s individual circumstances. Depending on the patient’s cancer diagnosis and prognosis, damages could include medical expenses incurred from cancer treatment, pain and suffering caused by the patient’s cancer and treatments, loss of income earning capacity, and loss of enjoyment of life secondary to the patient’s cancer.

06

Active Belviq Lawsuits

Since Belviq was removed from the market, product liability lawsuits against the drug’s manufacturer and U.S. sponsor have begun to appear. These lawsuits, which are in their infancy, typically claim that the companies behind Belviq had a duty to create a non-cancer-causing product or to alert consumers about the increased cancer risk. With very serious health implications on the line, lawsuits will surely continue to emerge regarding Belviq and its alleged links to cancer.

07

Speak to a Belviq Expert Witness

As Belviq lawsuits continue to develop, they are likely to require the perspectives of expert witnesses. Since Belviq targets serotonin production, neuroscience experts who can discuss serotonin’s role in the body may be among those consulted. Likewise, oncology experts may discuss how certain types of cancer develop within the body.

Physicians specializing in weight loss management may also be consulted on the benefits and risks of Belviq as a weight-loss drug, as well as on the relationship, if any, between increased weight and cancer risk. Pharmacology experts will be helpful for explaining the process by which Belviq was developed as well as its chemical composition. Experts in FDA approvals will also be essential for explaining how Belviq was approved for use in the United States and the regulatory responsibilities of the FDA.

As this litigation proceeds, expert witnesses will play a vital role in establishing the key technical and medical facts for judges and juries.

Expert E-007175
E-007175

Drug Safety & Pharmacoepidemiology Expert

This expert isProfessor and Head of the Department of Health Outcomes Research and Policy at a major university school of pharmacy. He holds a bachelors degree in pharmacy from the University of Wisconsin, and a PhD in Social, Administrative, and Clinical Pharmacy from the University of Minnesota. Prior to joining Auburn University he was Associate Professor of Pharmaceutical Outcomes and Policy in the Eshelman School of Pharmacy at the University of North Carolina. ...

Expert E-008030
E-008030

Psychiatry, Pharmacology and Toxicology Expert

This board-certified and fellowship-trained expert has over 40 years of experience working as a clinician and researcher of post-traumatic stress disorder. Listed in "The Best Doctors" in America, he is a Distinguished Lifetime Fellow of the American Psychiatric Association and the past president of the International Society of Traumatic Stress Studies. He has over 300 publications including 27 books and monographs. He currently serves as Professor of Psychiatry and ...

Expert E-008734
E-008734

Pharmaceutical Sciences and Clinical Pharmacology Expert

This highly qualified Professor of Pharmaceutical Sciences received a bachelors in Pharmacy and a PharmD in Clinical Pharmacy. He is a member of numerous highly regarded professional organizations including the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology. He is an innovator with 10 patents registered in his name. He is widely published in Pharmaceutical literature with over 350 articles. In addition to his academic ...

Expert E-009560
E-009560

Pediatric Hematology and Oncology Expert

This fellowship-trained doctor received his medical doctorate from the University of Massachusetts School of Medicine. He completed a fellowship in Clinical Pediatric Hematology-Oncology at the prestigious University of Chicago Medical center. He is currently an assistant professor in the department of pediatrics hematology/oncology at a, where he frequently lectures on topics such as vascular abnormalities of the newborn....

Expert E-013252
E-013252

Toxicology Expert

This highly qualified expert is a nationally renown authority in toxicology. He received his Ph.D. in pharmacology from the University of Kansas Medical Center. He has served as Toxicology Program Director in the Department of Environmental Health at the University of Washington, then as Associate Chairman of the Department, as Associate Dean for Research in the School of Public Health, and Associate Vice Provost for Research. He is currently Dean and Vice Provost of ...

Expert E-002872
E-002872

Internal Medicine and Clinical Pharmacology Expert

This expert began his career as a medical consultant to the emergency room drug treatment and referral program. He’s been practicing for over 40 years and focuses on internal medicine, consulting in clinical pharmacology, and quality assurance medicine. He is currently involved in many aspects of pharmacology, and holds many positions on boards and committees related to drug abuse, prevention, and treatment. He has been a special government employee consultant for the ...

Expert E-008844
E-008844

Pharmacology and Toxicology Expert

This highly qualified Professor of Pharmacology received a bachelor's degree from the University of Illinois and went on to receive a doctorate in Pharmacy from the University of Michigan. He is board certified in Clinical Pharmacology and Nutrition. He is a Fellow of both the American College of Clinical Pharmacology and the American College of Nutrition. he has won many awards throughout his career including the American Society of Pharmacy Law honor for legal ...

Expert E-008530
E-008530

Pharmacoepidemiology Expert

This highly qualified Associate Professor earned a masters in Public Health in Epidemiology from the highly regarded Bloomberg School of Public Health. He is board certified in Internal Medicine. He has won many honors throughput his career including the Bruce Squires Award for the Best Research Paper. He is a member of numerous professional societies including the International Society of Pharmacoepidemiology. He serves as a reviewer for more than 50 peer-reviewed ...

Expert E-010122
E-010122

Pharmacology & FDA Drug Safety Expert

This expert is a pharmacist and a pharmacologist and a former professor at Yale University and Georgetown University. He is also a former FDA Medical Officer/Senior Medical Analyst, who is an expert in the areas of drug Safety, drug development, regulatory affairs and FDA policy. He as also served as an advisor on the 2016 Ted Cruz presidential campaign, and has also been invited to testify in front of the U.S. Senate as a healthcare policy expert, FDA expert and ...

Expert E-014727
E-014727

CNS Medicinal Chemistry and Pharmacology Expert

This highly qualified expert has years of experience in the field of neuropharmacology. He received his PhD degree from the University of California, Santa Barbara, and completed his fellowship training at Harvard University. He is a member of various professional associations, including the American Society of Pharmacology and Experimental Therapeutics and the American Chemical Society. He has published 250+ peer reviewed journal articles and has 51+ US issued patents ...