Last February, just before the coronavirus shutdowns put everything on pause, the Food and Drug Administration (FDA) issued a Drug Safety Communication for the weight-loss drug Belviq. According to the FDA, studies show that Belviq increases the risk of certain types of cancers. In response to the FDA safety announcement for Belviq, Easai Inc. agreed to voluntarily withdraw the drug from the market. It now appears that Belviq is destined to suffer the same disastrous fate as many other prescription weight control drugs.
What is Belviq?
Belviq is the brand name for Lorcaserin, a new type of hormone appetite suppressant medication developed for the treatment of obesity. It was originally developed by Arena Pharmaceuticals and later manufactured and sold by Japanese-based pharmaceutical company Eisai.
The FDA approved Belviq in June 2012. Belviq was intended to complement a reduced-calorie diet and physical activity. It worked by suppressing one’s appetite. The drug came in two forms: a 10 mg tablet to be taken twice a day and a 20 mg extended-release tablet, named Belviq XR, to be taken once a day.
Initial FDA rejection of Belviq and its eventual approval
Even before its approval and initial release in 2012, there were questions and concerns about the safety of Belviq. When Arena initially applied to the FDA for approval of Belviq back in 2009, Endocrinologic and
The Metabolic Drugs Agency Committee (EMDAC) rejected the application. The EMDAC had concerns about an initial clinical trial on Belviq which found that it caused cancer in rats. They also found that it was not that effective with weight loss.
Despite this initial rejection, Arena did not stop pressing for the drug’s approval. Two years later, it submitted a study on Belviq concluding that it helped type 2 diabetics lose weight. Arena also submitted studies arguing the increased cancer risk was due to increased prolactin levels in rats. After five months, an EMDAC panel approved Belviq for the U.S. market.
The CAMELLIA-TIMI trial
To receive market approval, the FDA required Eisai to conduct a post-market cardiovascular safety study. The FDA has required all weight loss drug manufacturers to conducts these studies since 2010 when Meridia was recalled for increasing the risk of cardiovascular incidents.
The Belviq post-market study was named the CAMELLIA-TIMI 61 trial. Between February 2014 and November 2015, researchers randomly assigned Belviq or a placebo to 12,000 overweight or obese patients with either cardiovascular disease or other risk factors. They then followed up with these patients after a few years. The median follow-up was 39 months.
The researchers found that the drug helped patients lose weight without increasing the cardiovascular event risk. However, the results of the CAMELLIA-TIMI 61 trial also indicated that users of Belviq were more likely to be diagnosed with cancer compared to the control group. This seemed to reinforce the earlier results from the rat testing and prompted the FDA to take action.
January 2020 FDA Drug Safety Communication
On January 14, 2020, the FDA warned the public that Belviq was associated with an increased risk of cancer. However, the agency could not explain what caused cancer in Belviq patients. The FDA recommended that healthcare providers evaluate whether the drug’s benefits outweigh its risks. It advised Belviq patients to speak with their healthcare providers about the cancer risk.
February 2020 FDA withdrawal request
On February 13, 2020, the FDA requested a full market withdrawal of Belviq and advised all patients to stop taking the medication. They also advised them to speak with their physician about other weight loss medications and weight management programs. The FDA recommended disposing of unused Belviq in a drug collection site. It advised healthcare providers to stop prescribing the drug. This request was based on the FDA’s conclusion that Belviq was a possible carcinogen based on testing results.
Eisai’s voluntary recall of Belviq
Following the FDA’s request, Eisai announced that they were voluntarily recalling Belviq from the U.S. market. Despite issuing this recall, the pharmaceutical company disagreed with the FDA’s assessment. Eisai reiterated that Belviq had a “positive benefit-risk profile in the patient population for which they are indicated.” Nonetheless, it announced that they were respecting the FDA’s decision and would closely work with them to withdraw the drug from the U.S. market.
New England Journal of Medicine study
In September 2020 a study published in the New England Journal of Medicine definitively confirmed the association between Belviq and certain types of cancer. The NEJM study followed up on patients involved in the CAMELLIA-TIMI trial. Based on their data, the researchers found abnormally high rates of colorectal, pancreatic, and lung cancer in Belviq patients. They suggested that the risk of these cancers would be even higher in Belviq patients taking it long-term.
First Belviq Lawsuit filed in Missouri
The recall and studies linking Belviq to cancer opened the door to product liability lawsuits. The first Belviq lawsuit was filed in September 2020, in Missouri federal court against Eisai and Arena. The plaintiff claimed she developed breast cancer after taking Belviq for two years. The woman alleged that the Eisai and Arena failed to warn of the drug’s cancer risk. The woman also alleged that they failed to adequately test it. Since then a number of additional Belviq lawsuits have been filed around the country by other individuals who used Belviq and were later diagnosed with cancer.
Brazilian study on Belviq’s association with cancer
In the December 2020 edition of Obesity Reviews, Brazilian researchers also found that Belviq was associated with an increased risk for certain cancers. They conducted a meta-analysis of 11 trials and four studies. This included the CAMELLIA-TIMI trial. The researchers found that the drug was associated with lung and pancreatic cancers. However, they found no association with colon cancer. The researchers concluded that the evidence did not quite confirm Belviq’s cancer risk but suggested trends that could indicate otherwise.
Contact Miller & Zois About a Belviq Lawsuit
If you took Belviq for 12 months or longer and have subsequently been diagnosed with colon cancer, pancreatic cancer, or lung cancer you might qualify for a Belviq lawsuit. Our dangerous drug lawyers at currently looking for new Belviq cases, contact us online or call at 800-553-8082 for a free consultation.