FDA withdraws Belviq, Belviq XR approval due to cancer risks

At least a dozen lawsuits have been filed by Belviq users with cancer. More lawsuits are expected to be filed by lawyers involved in this litigation.

The Food and Drug Administration has formally withdrawn approval of the weight loss drugs Belviq and Belviq XR (lorcaserin), citing the increased cancer risk associated with these medications. The FDA had previously ordered the manufacturers of Belviq, Arena Pharmaceuticals and Eisai, to withdraw the two formulations of the drug in February after studies showed that patients who used the diet medications were more likely to develop cancer.

FDA orders Belviq recall citing increased cancer risks

Belviq and Belviq XR were approved by the FDA in 2012 and 2016, respectively. The drugs were designed to help patients lose weight in combination with diet and exercise by making them feel more fully after eating. Belviq was the first prescription weight loss drug approved by the FDA since the recall of Fen-Phen and Redux almost 20 years before.

When Belviq was first approved by the FDA in 2012, clinical trial data had shown that the weight loss drug was linked to an increased cancer risk in laboratory animals. Although the drug’s manufacturers denied that this meant that Belviq could cause cancer in humans, the FDA ordered additional clinical trials to determine whether the drug was linked to an increased cancer risk in patients who were prescribed Belviq.

In early 2020, the FDA received the first results from these clinical trials to investigate the cancer risk of Belviq. Preliminary data showed that patients taking Belviq were more likely to develop several types of cancers, including pancreatic cancer, colorectal cancer, and lung cancer.

After reviewing this data, the FDA ordered Arena and Eisai to withdraw Belviq and Belviq XR from sale in the U.S. In February 2020, the drugmakers complied with the FDA request, and the two weight loss drugs were taken off the market in the U.S.

FDA formally withdraws approval for Belviq and Belviq XR

Following the FDA’s decision to withdraw Belviq and Belviq XR, Eisai requested that the agency withdraw its approval of the drugs. The drugmaker waived its opportunity for a hearing in connection with the formal withdrawal of approval for the weight loss drugs.

In September 2020, the FDA announced that due to the increased cancer risk associated with Belviq, and following Eisai’s request, the agency was withdrawing formal approval of Belviq and Belviq XR. After the two drugs were stripped of their FDA approval on September 11, 2020, the agency publish a notice of its decision on September 17.

Belviq Cancer Lawsuits Filed Against Eisai and Arena

In the months following the FDA’s initial announcement of the link between Belviq and an increased cancer risk, patients who were diagnosed with cancer after using the weight loss medication have filed lawsuits against Eisai and Arena Pharmaceuticals. In addition to the numerous personal injury lawsuits that have already been filed, the drugmakers also face class action lawsuits over the link between Belviq and cancer.

The lawsuits filed against the two drugmakers allege that Eisai and Arena were aware of the cancer risks associated with Belviq and Belviq XR long before these were publicly announced by the FDA. Despite their knowledge of the side effects linked to the two drugs, these lawsuits allege that the two drug companies failed to properly warn doctors and patients about the risk of side effects faced by patients who were treated with Belviq or Belviq XR.

Free Legal Consultation for Belviq Users with Cancer

If you or a loved one used Belviq or Belviq XR for weight loss and have been diagnosed with colorectal cancer, lung cancer, pancreatic cancer, or other types of cancer, you may be eligible to file a lawsuit. The first step in taking legal action is to consult with an experienced pharmaceutical liability attorney, who can advise you regarding your legal rights and walk you through the first steps in filing a case.

For more information about whether you may qualify to file a Belviq lawsuit, contact the law firm of Hissey, Mulderig & Friend to schedule your free legal consultation with an attorney. You can reach us by calling toll-free at 1-866-210-5686, or by filling out our free online case evaluation form located on the right side of this page.

After we receive and review your information, a member of our staff will contact you for additional information and to schedule your free consultation with one of our lawyers.

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