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After eight years on the market with no cancer warning, federal regulators recently forced a Belviq recall after data from a new study found that users of the weight loss drug were diagnosed with pancreatic cancer, colorectal cancer, lung cancer and other cancers more frequently.
While the FDA indicated consumers should stop taking Belviq and speak with their doctors about concerns regarding the cancer risk, former users are raising questions about whether they need medical monitoring and individuals diagnosed with cancer are now pursuing potential Belviq lawsuits against the diet drug maker.
Concerns about potential Belviq side effects were raised shortly after the medication was approved in 2012, with the prominent consumer advocacy group Public Citizen predicting at that time that it may eventually be recalled due to signs of heart valve problems. However, while a post-marketing study required by the FDA did not find any cardiovascular risks, the results did result in the need to recall Belviq after an increased occurrence of various different cancers was identified among individuals receiving the weight loss drug, compared to those receiving a placebo.
The drug maker Eisai, Inc. marketed Belviq and Belviq XR as a safe and effective prescription weight loss drug, containing the active pharmaceutical ingredient lorcaserin. The drug is designed to promote weight loss among adults who are obese or have weight related medical problems that prohibit them from losing weight through traditional diet and exercise. The drug triggers chemical signals that make people feel full, and thus want to eat less. However, even the drug maker has acknowledged that the prices way Belviq works was not fully understood.
The Belviq cancer risk was identified following the review of data from a five-year, randomized, double-blind, placebo-controlled study conducted between January 2014 and June 2018, which involved 12,000 older men and women. Patients were randomly assigned to receive either the twice daily Belviq 10mg dose or a placebo.
According to the FDA, researchers found a “numerical imbalance” in the number of cancer cases, with one additiona cancer diagnosis observed per 470 patients treated for one year with Belviq. At least 462 patients taking Belviq were diagnosed with 520 primary cancers, which represented 7.7% of the users receiving the drug.
While a number of different cancers were observed, researchers noted that the imbalance specifically involved pancreatic cancer, colorectal cancer and lung cancer. In addition, there was no apparent difference in incidence of cancer during the first few months of treatment, but the imbalance increase the longer Belviq was used.
In a drug safety communication issued February 13, the FDA recommended that users immediately stop taking Belviq due to the cancer risk, recommending that they talk to their doctors about alternative weight-loss drugs or weight management programs.
While the agency did not monitor additional cancer screening for Belviq users, many individuals exposed to the recalled diet drug are questioning whether standard screening is sufficient.
It is widely expected that Belviq class action lawsuits will be filed to seek funding for medical monitoring, and individual product liability or wrongful death lawsuits are likely to be filed by former users already diagnose with cancer following use of Belviq.