Belviq was approved by the Food and Drug Administration (FDA) in June 2012 for long-term weight management in overweight and obese adults. On Feb. 13, 2020, the FDA called for the withdrawal of Belviq and Belviq XR (an extended release version approved in 2016) from the U.S. market because clinical trials showed that patients taking Belviq had an increased occurrence of cancer.
Attorneys with Beasley Allen Law Firm are currently handling Belviq lawsuits involving cases of cancer among people who took the diet pill Belviq, including pancreatic cancer, colorectal cancer, and lung cancer.
What is Belviq?
Belviq diet pill was approved to treat adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight), with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The approval was granted based on three clinical trials involving fewer than 8,000 overweight patients. The patients used the medication for 52 to 104 weeks. Compared to a placebo, patients taking Belviq for up to one year had an average weight loss ranging from 3% to 3.7%.
Belviq contains the active drug ingredient lorcaserin, which works by activating the serotonin 2C receptor in the brain. This activation is thought to help a person feel full after eating smaller amounts of food and, as a result, eat less.
Serotonin 2C receptor is the same appetite-controlling hormone targeted by fenfluramine, the “fen” in the notorious 1990s diet pill cocktail fen-phen. Fen-phen was pulled from the market in 1997 – less than 18 months after its approval – after being linked to potentially life-threatening heart valve problems in up to one in three patients treated with the drug.
The Belviq recall occurred on Feb. 13, 2020, after a long-term study found that people who used the diet pill had a higher occurrence of cancer.
Belviq and Belviq XR are manufactured by Eisai Inc.
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 also 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 distribute 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.
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. Afterwards, the agency examined all adverse events after randomization in the study, as opposed to simply “on treatment” events, which is 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 occurrence of cancer.
Eisai is based in Japan with U.S. headquarters in New Jersey. The company has annual revenues of more than $600 million.
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 Belviq cancer link – 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 occurrence of cancer 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, as well as multiple primary tumors and metastatic disease.
The FDA is recommending 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 involved about 12,000 patients. A total of 990 cancers were found among them including 520, or 7.7% , among Belviq users compared to 470, or 7.1%, among nonusers of Belviq.
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). There were also more deaths from cancer 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 compared to the placebo group — 26 versus 14. There were also 40 cases of lung cancer among Belviq users compared to 25 among nonusers. There were also more cases of leukemia (12 vs six) and liver cancers (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, there were 76 new cases of cancer 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 an excess cancer risk from lorcaserin, and 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.”
Attorneys with Beasley Allen Law firm have filed Belviq lawsuits investigating cases of cancer 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.
- Why was Belviq recalled?
- Belviq was withdrawn from the market on Feb. 13, 2020, after safety studies revealed a higher occurrence of cancer among Belviq users compared to nonusers – about one additional case of cancer per 470 patients taking Belviq for one year.
- What types of cancer are connected to Belviq use?
- Safety trial data showed that Belviq users had a higher occurrence of cancer compared to people given a placebo. The cancers most often seen among people taking Belviq include pancreatic cancer, colorectal cancer, and lung cancer. But other cancers may be linked to Belviq as well.
- Are there withdrawal symptoms from Belviq?
- Since Belviq affects neurotransmitters in the brain, some people may experience Belviq withdrawal symptoms, such as nausea, vomiting, dry mouth, constipation, headaches and dizziness.
- I have taken Belviq and been diagnosed with cancer. What can I do?
- If you have taken Belviq and have been diagnosed with cancer, you may be eligible for compensation from the manufacturer. Beasley Allen Law Firm is handling Belviq cancer lawsuits involving cases of cancer among people who used Belviq, such as pancreatic cancer, colorectal cancer, and lung cancer.