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Belviq® (Lorcaserin)

The popular weight-loss drug Belviq has been linked to a number of dangerous side effects, including increased cancer risks. In January 2020, the Food and Drug Administration (FDA) issued a drug safety alert regarding the potential link between weight loss drug, Belviq (lorcaserin), and an increased risk for developing several types of cancer including pancreatic, colorectal, lung and breast cancers. The FDA followed up on the safety alert in February 2020, by requesting Eisai Inc recall Belviq and Belviq XR from the market.

 

Issues with the safety of the weight-loss drug were evident even during its development. A study run by Arena Pharmaceuticals in 2007 showed that lorcaserin caused rare and aggressive tumors in rats. Disregarding these issues, Arena and Eisai resubmitted the new drug application for lorcaserin as Belviq in 2012.

FDA Warning

Belviq was subsequently given conditional approval by the FDA in 2013 but required Eisai to conduct a further long-term, post-market clinical study to study the potential risk of cardiovascular complications. In reviewing the data from the five-year-long post-market study, FDA investigators noted a significant increase in cancer diagnosis by those who had taken Belviq as opposed to the placebo among the 12,000 participants in the study. Shortly after this discovery, the safety alert and recall request to remove Belviq from the market were made by the FDA. In February 2020, Eisai voluntarily recalled Belviq.

 

In January 2021, veteran MDL US District Court of Louisiana Judge, Lance Africk, denied defense summary judgment motion with respect to a design-defect claim, allowing the case to continue forward.

Current Status Of Litigation

In April 2021 plaintiffs petitioned the JPML to consolidate proceedings to the Eastern District Court of Louisiana under Judge Lance Africk. The motion was denied by the panel in August, citing the limited number of cases filed and thus, informal coordination deemed unnecessary at the present time.

Links:

  1. https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-drug-safety-communication-due-possible-increased-risk-cancer
  2. https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-eisai-drug-safety-communication-fda-requests-withdrawal-weight-loss-drug
  3. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022529Orig1s000PharmR.pdf
  4. https://abcnews.go.com/Health/wireStory/weight-loss-drug-belviq-pulled-market-cancer-risk-68973534
  5. https://www.miamiherald.com/news/health-care/article240278116.html
  6. https://www.prnewswire.com/news-releases/eisai-to-voluntarily-withdraw-belviqbelviq-xr-in-the-us-301004885.html

Links:

  1. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3005-Order%20Denying%20Transfer-07-21.pdf