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FDA Requests Withdrawal of Belviq Over Cancer Risk
The Belviq recall [1] was initiated following the FDA’s review of safety data from the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial [2]. The trial looked at the risk of major cardiovascular events in people who took lorcaserin, the active ingredient in Belviq.
The trial was conducted between January 2014 and June 2018 and consisted of a cohort of 12,000 men and women who were overweight or obese. While researchers were looking into the cardiovascular effects of the drug, they also found more diagnoses of cancer among Belviq users compared to patients who took a placebo.
“There was a numerical imbalance in the number of patients with malignancies, with one additional cancer observed per 470 patients treated for one year … Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases,” FDA said. “There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin.”
This means the FDA determined the potential cancer risk with Belviq increases the longer patients use the drug — especially the risk of pancreatic cancer, colorectal cancer, and lung cancer.
Related Article: Belviq (Lorcaserin) Lawsuit Update
How Many People Got Cancer From Belviq?
When the FDA approved Belviq in 2012, the agency required Eisai Inc. to perform a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems. The trial was conducted on 12,000 patients and over the 5-year course of the study, at least 462 (7.7%) patients treated with lorcaserin were diagnosed with cancer compared to the placebo group, in which 423 (7.1%) patients were diagnosed with cancer.
Can You Still Buy Belviq?
No. Belviq has been discontinued and is no longer available in the United States since it was withdrawn in February 2020 because of the increased cancer risk associated with the drug.
Are There Belviq Alternatives?
The Belviq recall has left patients wondering what alternatives are available to help with their weight loss. Multiple weight loss drugs exist on the market, but like all medications, each option carries its own set of risks and potential side effects. Alternatives to Belviq currently available on the U.S. market include Contrave, Phentermine, and Saxenda.
What is the Newest Drug Approved to Prevent Obesity?
Semaglutide (generic: tripeptide) was approved by the FDA for the treatment of overweight and obesity in June 2021 (with similar medications currently being developed). Semaglutide doesn’t work for everyone, but when it’s successful, it can help someone shed up to 15% of their body weight.
However, Semaglutide has been linked to serious side effects including bleeding, blistering, burning, coldness, discoloration of the skin, a feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.
FAQs
What types of cancer are associated with Belviq use?
Types of cancer associated with Belviq use include pancreatic cancer, colorectal cancer, and lung cancer. The FDA’s analysis revealed a statistically significant increase in these cancers among Belviq users, leading to the drug’s market withdrawal.
What should I do if I have taken Belviq?
If you have taken Belviq, consult with your healthcare provider to discuss potential risks and monitor for any symptoms of cancer. Your doctor can provide guidance on appropriate screenings and alternative weight management options.
Can I file a lawsuit if I developed cancer after taking Belviq?
Yes, individuals who developed cancer after taking Belviq may be eligible to file a lawsuit. Consulting with a personal injury lawyer who specializes in pharmaceutical litigation can help determine your eligibility and guide you through the legal process.
How can I report adverse effects from Belviq to the FDA?
You can report adverse effects from Belviq to the FDA through the MedWatch Online Voluntary Reporting Form. Providing detailed information about your experience helps the FDA monitor drug safety and take necessary regulatory actions.
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