Belviq Cancer Risk
On Dec. 22, 2009, Arena Pharmaceuticals submitted an application to the FDA seeking approval for Belviq based on 18 clinical trials involving nearly 9,000 patients. The FDA held an Advisory Committee meeting in September 2010 during which members heard testimony from the drug maker and other parties. The following month, the FDA informed Arena and Eisai that it would not approve Belviq because there was not enough data regarding the occurrence of mammary and brain tumors in laboratory rats exposed to the drug and that a pathologist needed to examine those animal tissue samples for mammary and lung cancers as well as non-cancerous lesions.
The agency also questioned whether there was a correlation between Belviq and adenocarcinoma in lab rats and whether this could be translated to humans exposed to the drug. Adenocarcinoma is a type of cancer that starts in the mucus-producing glandular cells in the body. These can occur in any organ and are commonly seen in the breast, colon and rectum, lung, pancreas, and prostate.
The FDA wasn’t impressed with the weight loss results in patients and sought more studies proving Belviq’s effectiveness and that the potential benefits outweighed the risks.
Eisai, which took over exclusive rights to market and distributed Belviq in the U.S. beginning in 2012, resubmitted the application on Jan. 10, 2012. The FDA Advisory Committee met again in early 2012 and supported Eisai’s application. On June 27, 2012, the FDA officially approved Belviq marketing in the United States.
A year later, Eisai withdrew its application for approval of Belviq in Europe after the European Medicines Agency indicated that it was unlikely to approve the weight loss treatment based on the potential cancer link seen in animal studies. The agency also raised concerns about the drug causing tumors in humans, especially since the medication was intended as a long-term treatment.
Meanwhile, on July 19, 2016, the FDA approved Belviq XR, an extended-release version of Belviq.
Cancer Risk Emerges for FDA
The long-term safety trial data required by the FDA at the time Belviq was approved focused on the weight loss drug’s cardiovascular effects. While no major adverse heart problems were found, neither was the cancer risk. Afterward, the agency examined all adverse events after randomization in the study instead of simply “on treatment” events when the cancer risk emerged. The Belviq recall occurred on Feb. 13, 2020, after the long-term study found that people who used the diet pill had a higher cancer occurrence.
The approval of Belviq in 2012 was contingent upon the manufacturer conducting long-term safety studies to evaluate the risk of cardiovascular problems such as heart attacks and strokes. The studies tracked about 12,000 people over a five-year period and compared them to patients taking a placebo.
The study concluded in June 2018, but the focus was swiftly moved from cardiovascular concerns when the data revealed a link between Belviq and cancer. Several different cancers occurred more frequently among patients treated with Belviq. The FDA issued a Safety Communication on Jan. 14, 2020, warning the public of this risk and stating that the agency would continue to evaluate the clinical trial results.
On Feb. 13, 2020, the FDA called for the withdrawal of Belviq and Belviq XR due to the increased cancer occurrence in patients taking the diet pill, about 7.7% of Belviq users compared to 7.1% of nonusers. According to the FDA, one additional cancer diagnosis was observed per 470 patients taking Belviq for one year.
Cancers most often linked to Belviq use include:
- Pancreatic cancer
- Colorectal cancer
- Lung cancer
Belviq users may also be at increased risk for other cancers, including liver cancer and leukemia. Belviq was also linked to a higher rate of cancer-related death, multiple primary tumors, and metastatic disease.
The FDA recommends that people stop taking Belviq and talk to their doctor about alternative weight loss treatments and programs after long-term safety studies found that patients taking Belviq had a higher occurrence of cancers, including pancreatic cancer, colorectal cancer, and lung cancer, compared to people taking a placebo.
The FDA is not recommending special screening for patients who have taken Belviq diet pills. However, as with any individual, regardless of prior Belviq treatment, standard screening recommendations for cancer should be followed.
Belviq Safety Study
In September 2020, an analysis of the long-term safety study on Belviq, called CAMELLIA-TIMI, was published in the New England Journal of Medicine.
The CAMELLIA-TIMI 61 trial found 990 cases of cancer among about 12,000 patients. 520 of these cases were among Belviq users compared to 470 among nonusers.
While several types of cancers were noted in both groups, the Belviq group saw more patients with multiple primary tumors (20 compared to eight) and cases of metastatic disease (34 compared to 19). More deaths from cancer occurred in the Belviq group (53 at a median of 3.3 years follow-up compared to 33 in the placebo group).
Three cancers stood out in the study that were of particular concern. Sixteen Belviq users developed pancreatic cancer during the study period compared to only two in the placebo group. Belviq users also had nearly twice the number of colorectal cancers than the placebo group, 26 versus 14. There were also 40 cases of lung cancer among Belviq users compared to 25 among nonusers, more cases of leukemia (12 vs six) and more cases of liver cancer (10 vs four) in the Belviq group.
“The agency recognizes the importance of weight-loss therapies, but the magnitude of clinical benefit associated with modest weight reduction is uncertain, and this benefit may manifest only after years of sustained weight loss,” the group wrote. “Cancer risk may also be higher among patients using lorcaserin over the long term.”
For example, during the first 180 days of the trial, 76 new cases of cancer were diagnosed in the Belviq group compared to 77 in the placebo group. But when the cancer rate was checked at an interval of every 60 days beginning at day 180 through day 900, cancer diagnoses among Belviq users were consistently above 1.0.
The cancer-related safety signal from nonclinical studies supports the plausibility of excess cancer risk from lorcaserin. “The consistency of cancer findings in CAMELLIA-TIMI 61 and the robustness of sensitivity analyses further support a causative effect,” wrote John Sharretts, MD, of the FDA’s Office Division of Metabolism and Endocrinology Products in Silver Spring, Maryland, and colleagues. The increased risk of various cancer types associated with lorcaserin in the clinical study reflects the pattern seen in nonclinical studies.
Frequently Asked Questions About Belviq
File a Belviq Lawsuit
Attorneys with Beasley Allen Law firm have filed Belviq lawsuits. They are investigating cancer cases, including pancreatic cancer, colorectal cancer, and lung cancer, in patients who have been treated with Belviq. Please contact Roger Smith, Ryan Duplechin, or Melissa Prickett to discuss a possible Belviq lawsuit, or fill out our contact form on this website for a free consultation.