Belviq Cancer Lawsuits
Weight-loss drug Belviq (lorcaserin) has been prescribed since 2013 to help obese and overweight individuals experience more success with their weight-loss efforts. On February 13, 2020, however, the U.S. Food and Drug Administration (FDA) issued a safety communication noting that they had requested the withdrawal of the drug from the market.
A preliminary analysis of a post-marketing study on Belviq showed that patients taking the drug over a multi-year period were more likely to be diagnosed with cancer than those taking a placebo. After examining the results, the FDA concluded that the drug’s risks outweighed its benefits, and requested the manufacturer recall it.
Chaffin Luhana is currently investigating cases in which patients took Belviq or Belviq XR and then were diagnosed with cancer.
Belviq Linked with Increased Cancer Risk
The FDA set a condition upon its initial approval of Belviq in 2012, requiring the manufacturer to conduct a clinical trial to evaluate the risk of heart-related problems. Consumer-advocacy group Public Citizen also warned about potential health problems associated with the drug at the same time the FDA approved it in 2012.Public Citizen predicted the drug would eventually be withdrawn from the market, stating:
“The Food and Drug Administration (FDA) today recklessly approved another diet drug, lorcaserin, the latest in a series of obesity-related pharmaceuticals that pose serious health threats. We expect that as with many of the other drugs, this one will be withdrawn from the market after the agency is forced to confront the many serious adverse health effects, such as heart valve damage, that will be reported.”
Eisai Inc. complied with the FDA’s condition, testing the product in about 12,000 participants who were overweight or obese. The patients were required to have either established cardiovascular disease or to be at least 50 years old for men and 55 years for women with type 2 diabetes, plus at least one additional cardiovascular risk factor.
The participants were then randomly assigned to take either lorcaserin 10 mg twice daily or a placebo. The median follow-up was 3 years and 3 months, and about 96 percent of the patients completed the study. A preliminary safety analysis showed no significant difference between the drug and the placebo when it came to major cardiovascular events like heart attack and stroke. But there was a difference in the number of patients who were diagnosed with cancer.
During the course of the trial, 462 (7.7 percent) of the patients treated with lorcaserin were diagnosed with cancer—including pancreatic, colorectal, and lung cancer—versus 423 (7.1 percent) of the patients taking the placebo. The longer the patients took the drug, the more of an imbalance there was, indicating that the cancer risk may increase with longer-term drug use.
On January 14, 2020, the FDA released a safety communication alerting the public to the results, stating it couldn’t conclude that lorcaserin contributed to cancer risk, but that it would continue to evaluate the trial results.
On February 13, 2020, the FDA announced that it was requesting the manufacturer of Belviq and Belviq XR to voluntarily withdraw the weight-loss drug from the market “because a safety clinical trial shows an increased occurrence of cancer.” The agency further stated it believed the risks of lorcaserin outweighed its benefits based on its completed review of the trial results.
Eisai Inc. complied with the FDA’s request, announcing it would voluntarily withdraw from the market and discontinue sales of Belviq and Belviq HR in the U.S. “This action is being taken after a request from the U.S. Food and Drug Administration (FDA),” the company stated.
Eisai’s interpretation of the data, however, differed from that of the FDA: “The Company’s assessment is that Belviq and Belviq SR continue to have a positive benefit-risk profile in the patient population for which they are indicated.”
Types of Injuries Associated with Belviq
Considering the results of the trial, Belviq may be associated with:
- Colorectal cancer
- Lung cancer
- Pancreatic cancer
- Other types of cancer
What is Belviq?
Belviq was created and manufactured by Arena Pharmaceuticals, which submitted a new drug application to the FDA on December 22, 2009. The company had performed initial critical trials on the drug involving over 8,500 patients, and found that lorcaserin “consistently produced significant weight loss with excellent safety and tolerability.”
Lorcaserin was the first in a new class of selective serotonin receptor agonists that help people lose weight by controlling appetite. It binds to the serotonin receptor known as the 5-HT2C receptor in the hypothalamus, fooling the brain into thinking it’s satisfied and doesn’t need more food. When taking the drug, patients are likely to be able to eat less and feel full after eating smaller amounts of food.
The FDA sent a response to Arena in October 2010, noting that it could not approve the application for several reasons, including unclear safety margins. Some Belviqu studies had linked the drug to an increased risk of cancer and tumors in animal subjects. The agency gave the company instructions on how to address the issues, and Arena submitted its response in January 2012.
The FDA then convened a meeting of an advisory committee to discuss the drug’s application. The committee voted 18 to 4, with one abstention, that based on the available data, the potential benefits of the drug outweighed any potential risks when used long-term in a population of overweight and obese individuals.
The official approval was dated June 27, 2012. Specifically, the drug was approved for use in adults with a body mass index (BMI) of 30 or greater (defined as obese), or adults with a BMI of 27 or greater (overweight) and who had at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
In November 2013, Arena Pharmaceuticals concluded an agreement with Eisai Inc., a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. to market and supply Belviq. In December 2016, the two companies expanded that agreement giving Eisai all development and marketing rights to the product worldwide.
In July 2016, the FDA approved the new drug application for Belviq XR, an extended-release version of the drug that enabled once-daily treatment, compared to the twice-daily original Belviq tablets.
Belviq Cancer Lawsuits
Patients who took Belviq for years may now be understandably concerned about their potential cancer risk. Even more concerning is why the manufacturers didn’t warn about the drug’s potential to increase cancer risk long before its withdrawal from the market.
If you took Belviq or Belviq XR and were later diagnosed with cancer, you may be eligible to file a Belvq lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.