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Belvic Weight Loss Drug Lawsuit
‘Potential Risk Of Cancer Outweighs The Benefits’: Weight-Loss Drug Belviq Pulled From US Market Over Cancer Concerns
The United States Food and Drug Administration (FDA) issued on February 13 a drug safety communication urging that the prescription weight-loss drug Belviq (lorcaserin) be withdrawn from the US market after new clinical data showed an increased incidence of cancer in patients taking Belviq over a five-year period. The FDA recommendation also includes the extended-release version Belviq XR.
“The U.S. Food and Drug Administration (FDA) has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer,” the FDA Drug Safety Communication states.
In response, Japanese drugmaker Eisai Inc., manufacturer of Belviq and Belviq XR, “has submitted a request to voluntarily withdraw the drug,” the FDA said.
The FDA has instructed patients presently prescribed Belviq or Belviq XR to stop taking the drug immediately and to properly dispose of any remaining tablets. At this time, the FDA is not recommending additional cancer screenings or other measures for patients who have been taking Belviq.
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Belviq Weight Loss Drug Lawsuit
What Is Belviq (lorcaserin)?
First approved by the FDA for release on the US market in 2012, Belviq (lorcaserin) is a prescription weight-loss drug belonging to a group of medications known as serotonin receptor agonists. When accompanied by a calorie-restricted diet and appropriate exercise, Belviq is believed to assist obese individuals with weight management by increasing feelings of “fullness” when eating, thereby reducing the number of calories consumed.
“Lorcaserin is used to help adults who are obese or who are overweight and have weight-related medical problems to lose weight and keep from gaining back the weight,” describes Medline Plus, a website from the US National Library of Medicine, part of the National Institutes of Health (NIH).
According to an analysis by Bloomberg News and Symphony Health Belviq achieved its top US sales numbers in 2015 when upwards of 600,000 prescriptions were filled. The same analysis shows that, a year earlier, Belviq manufacturer Eisai earned nearly $50 million in revenue from Belviq sales across North and South America.
Belviq (lorcaserin) Concerns Arise
However, even at the time of Belviq’s initial approval, the US FDA harbored some skepticism about the drug’s safety, though these concerns primarily centered around Belviq’s potential impact on the human heart. Preliminary data also suggested that Belviq could be associated with an increased risk of cancer in rats. These worries led the FDA to demand at the time of Belviq’s 2012 approval that its manufacturer Eisai conduct a long-term clinical study on the drug’s safety in humans.
“When approving lorcaserin, we required the drug manufacturer, Eisai Inc., to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems,” the FDA explained in an earlier Belviq drug safety communication, dated January 14. “In this trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking lorcaserin were diagnosed with cancer compared to patients taking a placebo, which is an inactive treatment.”
While the FDA included in the January 14 communication the caveat that its “evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer,” by a month later, on February 13, the FDA was recommending that Belviq be pulled from the US market completely.
A website formerly set up as a marketing platform for Belviq has now been replaced with a text-only statement from Eisai Inc.
“Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA,” Eisai’s statement says. “The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive risk-benefit profile in the patient population for which they are indicated. However, based on the change in FDA’s risk-benefit assessment and as requested by the Agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market.”
Eisai says its conclusions about Belviq’s safety are based on evidence gathered "in more than 30 clinical trials involving over 22,000 patients over the last 15 years.”
However, the company concedes that the FDA found the data gathered in the CAMELLIA-TIMI 61 trial troubling enough to request the drug be withdrawn from the market.
“Following its review of the data, FDA concluded that the potential risks of lorcaserin outweigh its benefits,” Eisai says. “More specifically FDA noted there was a numerical imbalance in the number of patients with malignancies. FDA’s analysis of the study found that during the course of the trial, 462 (7.7 percent) patients treated with lorcaserin were diagnosed with cancers compared to the placebo group, in which 423 (7.1 percent) patients were diagnosed with cancers.”
Potential For Legal Action
While it is relatively early for prospective plaintiffs to have brought legal action against Eisai over its drug Belviq’s apparent potential for increasing a patient’s cancer risk, as the situation develops, there certainly is the possibility for significant legal fallout.
For a somewhat analogous situation, one need look no further than the ongoing recalls of the generic blood-pressure medication valsartan and related drugs due to their contamination with probable human carcinogens. While some plaintiffs have sued alleging that they already have developed cancer from taking contaminated valsartan, such injuries can take years if not decades to develop, and their cause can be difficult if not impossible to prove in court.
However, valsartan plaintiffs have found other avenues to sue the makers and distributors of the contaminated drugs, providing a template of sorts for potential Belviq plaintiffs. For example, multiple putative class-action lawsuits have been filed by plaintiffs seeking reimbursement for the money they spent on contaminated valsartan, saying they in essence wasted money on medications not fit to be on the market in the first place.
Belviq patients potentially could sue on similar grounds, claiming that they purchased Belviq on the belief that it would improve their health when, according to the FDA, its potential risks actually outweigh the supposed benefits. With the Associated Press reporting that a Belviq prescription can cost patients as much as $300 per month, such expenses easily could run into the many thousands of dollars per individual plaintiff.
Other valsartan plaintiffs include insurance companies who allege they were forced to pay increased drug costs as a result of a price spike prompted by the valsartan recalls. If the removal of Belviq from the US market results in similar cost increases for alternative treatments, one could see analogous lawsuits filed.
And, as frequently happens, once cases begin to go through the pretrial discovery process, plaintiffs could unearth internal company documents and other evidence providing the basis for other potential causes of action, as well.
In any event, the public-health, political, and legal ramifications of Belviq’s removal from the US market are now only beginning to be felt.
United States Food and Drug Administration (FDA). (13 February 2020). FDA requests the withdrawal of the weight-loss drugs Belviq, Belviq XR (lorcaserin) from the market. Drug Safety Communications. https://www.fda.gov/media/135189/download
MedlinePlus. (Accessed 20 February 2020). Lorecaserin. MedlinePlus.gov. National Library of Medicine. National Institutes of Health
The Washington Post. (14 February 2020). Weight-loss drug Belviq pulled off U.S. market because of cancer concerns
United States Food and Drug Administration (FDA). (14 January 2020). Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin). Drug Safety Communications
Belviq.com. (Accessed 20 February 2020)
Johnson, L. (13 February 2020). Weight loss drug Belviq pulled from market over cancer risk. AP News
Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.
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