Why Was Belviq Recalled from the FDA?

January 21, 2021

Belviq – a weight-loss drug approved by FDA and released in 2012 – showed great promise as one of the first weight-loss drugs without increased risk of heart disease. Yet, in February 2020, it was taken off the market for potentially increasing the risk of cancer. A few months later, a woman named Barbara Zottola filed a lawsuit against Eisai Inc., the New Jersey manufacturer of Belviq. She alleged that Eisai had known about the drug’s cancer risk for years, but had failed to disclose it. The lawsuit also includes Arena Pharmaceuticals Inc. who developed and licensed the active ingredient lorcaserin. 

Belviq & Other Weight-Loss Drugs

Weight-loss drugs have come a long way since they were first made available in the late 1800s, but they are not without risk. The challenge remains: Do their benefits outweigh their risks? The holy grail for  weight-loss drugs is to mitigate the health risks caused by obesity without any side effects. Some of the obesity risks include an increased risk of coronary heart disease by 12 percent and risk of stroke by 24 percent. History shows that has not always been the case. For example, Fen-Phen – the combination of fenfluramine and phentermine – was banned in 1997 for causing permanent damage to the heart. 
Belviq (lorcaserin) was the first weight-loss drug approved by the FDA in thirteen years. It was followed by Qsymia a month later, and Contrave and Saxenda in 2014. With Qsymia, one could lose the most weight, but had the additional risk of possible birth defects. With Contrave, side effects at the time appeared to be more severe than Belviq. 

How Belviq Works

Belviq lowers appetite by affecting the brain’s response to serotonin, the mood-stabilizing neurotransmitter. But unlike antidepressants, Belviq only increases feelings of satisfaction and fullness where the appetite is concerned. 
FDA approved Belviq use for anyone who is obese, with a body mass index (BMI) of 30 or higher, or overweight, with a BMI of 27 or higher.
While Belviq had common side effects such as headache, nausea, constipation, fatigue, dizziness and low blood sugar, it appeared to be safer for the heart and safer overall. A long-term clinical trial required by the FDA confirmed the lack of  cardiovascular side effects, but it showed a small, but significant increase in cancer risk for participants. That led to its recall in 2020.

Belviq Lawsuit and Link to Cancer

The Belviq lawsuit states that the developer Arena Pharmaceuticals Inc. was aware of lorcaserin’s link to cancer, but chose to withhold those findings for more profit, putting the public at risk. 
To gain FDA approval, Arena led a “Rat Study” to assess the risk of lorcaserin for humans. In 2007, the study revealed that lorcaserin caused “mammary, brain, skin and nerve-sheath tumors, including lethal, malignant mammary and brain tumors,” according to the lawsuit. The cancers showed up early in the study and were aggressive. 
In March 2008, the results worsened at all doses, with a higher number of deaths caused by mammary-tumors. A month later, however, Arena updated the results to state that there were less malignant mammary-tumors and more benign tumors. 
According to the lawsuit, Arena failed to disclose the full extent of the findings from the rat study, and made false statements concerning the weight-loss drug. Zottola believes the drug would not have made it to the market had the FDA known the full truth.

If You Are Impacted by Belviq

If you developed cancer after using Belviq, you have legal options and the support of our law firm. A weight-loss drug that pledged to improve your health should improve your health without prompting new and unexpected challenges in your life. You should not be kept in the dark about any side effects – especially as grave as cancer. Contact the San Diego Belviq attorneys at Estey & Bomberger, LLP anytime, and we will be there for you.