Belviq

Introduction

Belviq (lorcaserin) is a medication prescribed to help patients lose weight and belongs to a group of drugs called Anorexiants. The primary function of Anorexiants is weight loss, as they act as an appetite suppressant. Belviq works by targeting the hunger receptors in the brain and makes an individual feel full sooner while reducing appetite. The FDA approved Belviq in 2012 to be used by obese or overweight adults in conjunction with a reduced calorie diet and exercise to increase weight loss. Belviq was available in a tablet (Belviq) and an extended-release tablet (Belviq XR). The drug is manufactured by Eisai Inc., a subsidiary of a Tokyo based pharmaceutical company.

Prior to Belviq’s approval, the FDA feared that Belviq may cause heart-related complications similar to prior weight loss drugs like fenfluramine/phentermine (fen-phen). Therefore, the FDA approved Belviq, but they requested that a randomized, double-blind, placebo-controlled clinical trial be conducted to evaluate the potential risk of heart related problems associated with the drug. In this trial, which reviewed 12,000 patients over a five year period, more patients taking Belviq compared to those taking the placebo were diagnosed with cancer.

History of the Case

A five-year study of 12,000 participants from many different areas of the world was performed to study the long-term effects of Belviq. Common side effects included relatively normal conditions such as headaches, dizziness, dry mouth, nausea, constipation, and back pain. In fact, the study concluded that Belviq was an effective weight loss drug with the group taking Belviq losing more weight on average than the control group. In addition to this, it was found that Belviq can help to lower blood sugar. For people who are taking this drug and are prediabetic this translates to a lower risk of diabetes.

Cancer concern?

However, the FDA became concerned when it was found that Belviq may be causing cancer. During the study, the group taking Belviq reported positive cancer diagnoses in greater numbers than the placebo control group (7.7% vs 7.1%). The study, published in the New England Journal of Medicine, showed an increase in several different types of cancers but specific increases in colon, lung, and pancreatic cancers.  Although Eisai Inc. continues to maintain that Belviq has a positive benefit to risk ratio for its clients – the FDA disagrees.

FDA recall

On January 14, 2020, the FDA issued a warning letter stating that Belviq may cause an increased risk of cancer, but that final conclusions are still uncertain. Because of these findings, the FDA requested the withdrawal of Belviq from the market, and Eisai Inc. has complied. The FDA has promised to continue to evaluate the results of the clinical trial and communicate their final assessment of Belviq. Belviq is no longer available in the United States. Lorcaserin has no generic type and is only produced by Eisai Inc. as Belviq. This means that after the market withdrawal, this drug is no longer available in any form. Patients taking this weight loss drug should speak with their doctors about possible alternatives.

Injuries Related to Product

Cancers Possibly Linked to Belviq:

• Colon
• Bladder
• Lung
• Hepatic
• Prostate
• Bone
• Breast
• Ovarian
• Kidney
• Urethral
• Uterine

Additional Literature

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Gustafson, A., King, C., Rey, J. (2013) Lorcaserin (Belviq) A Selective Serotonin 5-HT2C  Agonist In the Treatment of Obesity. Drug Forecast, 38, 9, 525-534… Continue