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Why Did the FDA Recall Belviq

Alicia Betz
August 14, 2023

If you or a loved one have taken Belviq (also known as lorcaserin), you undoubtedly want to know why the weight-loss drug was recalled.

Lorcaserin, the active ingredient in Belviq, belongs to a class of drugs known as serotonin-receptor agonists. The drug reduces appetite by activating receptors in the brain that control appetite. This causes people who take it to feel more full, subsequently making them eat less.

In February 2020 however, the FDA recalled Belviq due to concerns that the drug is associated with an increased cancer risk. After the FDA requested the recall, the manufacturer, Eisai Inc. voluntarily recalled Belviq.

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If you or a loved one had cancer after using Belviq, Select Justice can help you fight for your rights and compensation.


It’s not a good feeling to know that you have taken a drug that might negatively affect your health. Facts can help calm worries and fears however, so continue reading to learn more about the recall and the facts about the connections between Belviq and cancer.



Health Concerns of Belviq

Belviq has been associated with both heart valve problems and an increased risk of cancer. It was ultimately the increased cancer risk that caused the recall. After the drug was approved in 2012, the FDA required Eisai Inc. to complete additional tests on efficacy and safety because previous clinical trials indicated cardiovascular and cancer risks. This led to a long-term safety clinical trial of Belviq.

When researchers followed up with test participants five years later, 7.1% of people in the placebo group developed cancer while 7.7% of people in the Belviq group developed cancer.

The types of cancer that were especially prevalent included lung cancer, pancreatic cancer, and colorectal cancer.

While the news about Belviq and cancer is scary, if you have taken Belviq and have not developed cancer, it is reassuring to know that the incidence of cancer is only slightly higher than the control group (.6%). However, according to the FDA, the risks of taking the drug outweigh the benefits.

The FDA does not recommend additional cancer screenings for people who have taken Belviq. They do however, recommend that anyone still taking the drug stop taking it and contact their healthcare provider to discuss alternative weight-loss strategies. Of course, if you have concerns about your health, you should also talk to your doctor about your symptoms and discuss potential screenings.

Belviq Lawsuit

The History Of Belviq

Even at the time of approval in 2012, Belviq was linked to an increased risk of cancer in rats, and there were additional concerns about cardiovascular health. A 2007 study indicated that it caused rare and aggressive tumors in rats. In 2010, the FDA rejected an application for Belviq approval; the agency said the reasons were “due to safety concerns, specifically cancer risk.” Nonetheless, in 2012 when the drug was resubmitted for approval, the FDA approved the second application.

In a letter warning about the safety concerns of Belviq, Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group called the FDA’s approval of the drug reckless. She also noted that the FDA approved Belviq reluctantly due to its connection to concerns with cardiovascular health. In addition to the trial showing cancer in rats, clinical trials completed before the drug was approved also showed a link to heart valve problems. These cardiovascular concerns were the reason the FDA requested an additional clinical trial when the agency approved the drug in 2012. The purpose of the clinical trial was to assess the long term safety of Belviq.

Belviq Lawsuit News Updates - 2023

People who developed cancer after taking Belviq began filing lawsuits shortly after the drug was recalled. The cases are ongoing, and are in the early stages. To date, there have been no verdicts, nor have there been settlements.

  • July 1, 2023 - FDA withdraws weight-loss drug Belviq and Belviq XR from the market.
  • March 1, 2023 - Mayo Clinic update - Belviq (Lorcaserinint) side effects update.
  • February 1, 2023 - After FDA flagging cancer risks, Eisai will take Belviq, an obesity drug from the U.S.
  • January 1, 2023 - After FDA flags potential cancer risks, Eisai will take Belviq, an obesity drug from the U.S.
  • November 21, 2022 - Belviq Update November 2022 - Uses, Side Effects, and More.
  • September 1, 2022 - 4 Medications doctors will never prescribe again - Belviq for weight loss is one of them.
  • August 1, 2022 - Researchers show effectiveness of migraine drug in weight loss.
  • July 1, 2022 - The FDA is proposing that all drug products containing lorcaserin hydrochloride be added to the withdrawn or removed list under sections 503A and 503B of the FD&C Act.
  • June 1, 2022 - Belviq XR Side Effects:
    • Nervous system: Headache, Dizziness
    • Cardiovascular: Hypertension
    • Psychiatric: Anxiety, insomnia, stress, depression/mood problems
    • Hematologic: Decreased lymphocyte count, decreased hemoglobin
    • Endocrine: Hypoglycemia
    • Respiratory: Upper respiratory tract infection
  • May 1, 2022 - U.S. Department of Justice, Drug Enforcement Administration Diversion Control Division, Drug & Chemical Evaluation Section: Belviq (Lorcaserin) is the list of Scheduling Actions Controlled Substances Regulated Chemicals.
  • February 1, 2022 - Cleveland Clinic - Belviq XR (Lorcaserin) side effects list update.
  • January 1, 2022 - National Library of Medicine - Belviq (Lorcaserin hydrochloride hemihydrate) Chemical and Physical Properties.
  • February 13, 2021 - FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR Lorcaserin from the market. F.D.A. has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) withdraw the drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer.
  • February 6, 2021 - Eisai Inc. announced that it will voluntarily withdraw from the market and discontinue sales of Belviq (lorcaserin HCl) CIV and BELVIQ XR (Lorcaserin HCl) CIV in the U.S. This action is being taken after a request from the U.S. Food and Drug Administration (FDA), based on the Agency’s recently completed analysis of data from the CAMELLIA-TIMI 61 trial.

What To Do If You Believe You’ve Been Harmed by Belviq

If you or a loved one have taken Belviq and subsequently developed cancer, you’re undoubtedly scared and upset. You also probably want to seek justice and get compensation for your medical bills and for the emotional toll you’ve experienced. Others have already started filing claims, and you can also find out if you are eligible to file a claim as well.

Free Case Evaluation

If you or a loved one had cancer after using Belviq, Select Justice can help you fight for your rights and compensation.


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We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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