Belviq, Belviq XR, and Increased Risk of Cancer

Belviq and Belviq XR are no longer available for use in the U. S. due to an increased risk of cancer. This market withdrawal was requested by the FDA in February 2020. If you took this weight loss drug and were diagnosed with cancer, you should talk to an attorney about your potential options for suing the drug manufacturer for your injuries.
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What Is Belviq?

Belviq (lorcaserin) is a drug that was approved for weight management, when used with increased physical activity and a lower calorie diet. Its extended-release formulation was approved as Belviq XR. Both are prescription medications. Belviq was approved by the U.S. Food and Drug Administration (FDA) in June 2012 and Belviq XR in July 2016. (1)

Belviq and Belviq XR are also known by their generic name, lorcaserin. Lorcaserin is intended to be used as a “satiety promoter,” which means it is supposed to help patients feel less hungry. (2)

Belviq and Belviq XR were approved for use in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or who are overweight, with a BMI of 27 kg/m2 or greater, and have at least one weight-related comorbidity, such as hypertension or type 2 diabetes. (3)

FDA Requests Withdrawal Over Cancer Risk

Both Belviq and Belviq XR have been withdrawn from the market in the U. S. because patients face higher risk of developing certain types of cancers. The higher number of cancers diagnosed in patients taking Belviq compared to those taking a placebo in a clinical trial “increased with longer duration on lorcaserin.” (4)

According to the FDA, the agency took action to request the market withdrawal because it believes “the risks of lorcaserin outweigh its benefits based on [the FDA’s] completed review of results from a randomized clinical trial assessing safety.” (5)

At the request of the FDA, the manufacturer announced in February 2020 that it would discontinue its sales of this medication and voluntarily withdraw Belviq and Belviq XR from the U.S. market. (6)

For a free Belviq consultation and more information about your legal options, please contact us today.

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Lawsuits Due to Cancer from Belviq

Weitz & Luxenberg is now accepting cases from people who developed these types of cancer after taking the weight management drug Belviq or its extended-release version, Belviq XR:

  • Pancreatic cancer.
  • Colorectal cancer.
  • Lung cancer.

If you were taking Belviq or Belviq XR and were later diagnosed with one of these cancers, reach out to us.

You may be entitled to seek compensation from the drug manufacturer for your injuries. We can provide more information on your legal rights during a free consultation.

One of our experienced attorneys can help you consider your legal options. Our team of defective drugs litigation attorneys has been handling complex pharmaceutical litigation for more than 35 years. We would feel privileged to assist you.

Side Effects of Belviq and Belviq XR

Belviq and Belviq XR have many side effects.

Cancer

Cancers that have been found disproportionately in Belviq-treated patients include pancreatic, colorectal, and lung cancer. The American Cancer Society provides estimated survival rates based on when cancer is first diagnosed. (7)

Patients first diagnosed when their cancer is localized often have a better projected survival rate after five years than patients first diagnosed when their cancer has spread (metastasized) to other areas in their body. Local to distant staged cancer estimated 5-year survival rates from the American Cancer Society for pancreatic, colorectal, and the most common type of lung cancer (non-small-cell lung cancer) are: (8)

  • Pancreatic — 37% to 3%. (9)
  • Colorectal — 90% to 14%. (10)
  • Non-small-cell lung cancer — 61% to 6%. (11)

Other Serious Side Effects

Taking Belviq and Belviq XR can also cause a number of additional serious side effects, including the following that are warned of in labeling: (12)

  • Serotonin syndrome or neuroleptic malignant syndrome-like reactions.
  • Valvular heart disease.
  • Cognitive impairment.
  • Psychiatric disorders, including euphoria and dissociation.
  • Depression or suicidal thoughts.
  • Potential for hypoglycemia in those with diabetes who are also using antidiabetic medication.
  • Priapism.

Common Side Effects

The most commonly reported adverse reactions (occurring in more than 5% of patients) reported in nondiabetic patients noted in the Belviq and Belviq XR labeling include: (13)

  • Headache.
  • Dizziness.
  • Fatigue.
  • Nausea.
  • Dry mouth.
  • Constipation.

The most commonly reported (occurring in more than 5% of patients) adverse reactions occurring in diabetic patients taking Belviq or Belviq XR noted in the labeling include: (14)

  • Hypoglycemia.
  • Headache.
  • Back pain.
  • Cough.
  • Fatigue.

Study Showed Cancer Risk

The results of the 5-year study requested by the FDA demonstrated that more patients who took lorcaserin were diagnosed with cancer compared to those who took a placebo, an inactive treatment.(15)

When approving Belviq for use and distribution in the United States in 2012, the FDA required the drug’s manufacturer to conduct a clinical trial to examine the potential risk of cardiovascular side effects occurring in patients taking lorcaserin. The study was called the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial. (16) (17)

The clinical study evaluated 12,000 patients over 5 years. It discovered that patients receiving lorcaserin developed a range of cancer types at a greater rate than those taking placebo. (18) (19)

The clinical study occurred from January 2014 through June 2018 in the United States, Canada, Mexico, the Bahamas, Europe, South America, Australia, and New Zealand. (20)

FDA Issues Safety Communications

In early 2020, the FDA issued two separate safety communications regarding Belviq and Belviq XR. The communications were based on the FDA’s completed data analysis from the postmarket clinical study of lorcaserin.

The FDA informed the public that the CAMELLIA-TIMI 61 clinical trial demonstrated an increased occurrence of cancer with patients prescribed Belviq or Belviq XR (lorcaserin) compared to those taking placebo.

In January 2020, the agency alerted the public about a possible increased risk of cancer linked to these medications based on its initial analysis. (21)

On February 13, the agency requested for Belviq’s manufacturer, Eisai Inc., to voluntarily withdraw this weight-loss medication due to the data indicating an increased occurrence of cancer in Belviq-treated patients in the CAMELLIA-TIMI 61 trial. (22) (23)

What To Do If You Took Belviq or Belviq XR

The FDA has advised patients to stop taking lorcaserin and talk to their health care professionals about other possible weight-loss drugs and weight-management programs.(24)

The FDA also advised health care professionals to stop prescribing and dispensing lorcaserin to their patients. The FDA further requested health care professionals to notify their patients currently taking lorcaserin to inform them about the increased occurrence of cancer linked to this weight-loss medication demonstrated in the clinical trial.(25)

You may want to talk with your doctor or another health professional, read the FDA safety communications, or call the FDA for more information.

W&L Successes with Other Drug Lawsuits

Weitz & Luxenberg has helped thousands of clients harmed by defective drugs. Over the years, we have won billions of dollars on behalf of our clients. Wins for our clients include:

*Past performance is no guarantee of future results. The Actos verdict was reduced to approximately $38 million by the trial court on October 27, 2014. The settlements in which Weitz & Luxenberg played leadership roles included patients not represented by W&L.

  1. Eisai Inc. GlaxoSmithKline. (2017, May). Belviq/Belviq XR Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf
  2. Voelker, R. (2020, February 18). FDA Assesses Potential Cancer Risk Associated With Weight Loss Drug. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2761071
  3. Eisai Inc. GlaxoSmithKline. (2017, May). Belviq/Belviq XR Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf
  4. U.S. Food & Drug Administration. (2020, February 13). FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market
  5. Ibid.
  6. Eisai Co., Ltd. (2020, February). Prescribing Information. Belviq. Retrieved from https://www.belviq.com
  7. American Cancer Society. (2020, January 8). Survival Rates for Pancreatic Cancer. Retrieved from https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html
  8. American Cancer Society. (2019). Cancer Treatment & Survivorship. Facts & Figures 2019-2021. Retrieved from https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-treatment-and-survivorship-facts-and-figures/cancer-treatment-and-survivorship-facts-and-figures-2019-2021.pdf
  9. Ibid.
  10. American Cancer Society. (2020, January 8). Survival Rates for Colorectal Cancer. Retrieved from https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
  11. American Cancer Society. (2020, January 9). Lung Cancer Survival Rates. Retrieved from https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html
  12. Eisai Inc. GlaxoSmithKline. (2017, May). Belviq/Belviq XR Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022529s005s007,208524s001lbl.pdf
  13. Ibid.
  14. Ibid.
  15. Voelker, R. (2020, February 18). FDA Assesses Potential Cancer Risk Associated With Weight Loss Drug. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2761071
  16. U.S. Food & Drug Administration. (2020, January 14). Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer. Retrieved from https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-drug-safety-communication-due-possible-increased-risk-cancer
  17. U.S. Food & Drug Administration. (2020, February 13). FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market
  18. Eisai Co., Ltd. (2020, February). Prescribing Information. Belviq. Retrieved from https://www.belviq.com
  19. U.S. Food & Drug Administration. (2020, February 13). FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market
  20. Ibid.
  21. U.S. Food & Drug Administration. (2020, January 14). Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer. Retrieved from https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-drug-safety-communication-due-possible-increased-risk-cancer
  22. Ibid.
  23. U.S. Food & Drug Administration. (2020, February 13). FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market
  24. Ibid.
  25. Ibid.

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