Shedding Pounds and Getting Cancer: Facts About Recalled Weight Loss Drug Belviq

NOTICE: The weight loss drugs known as Belviq (lorcaserin hydrochloride) and Belviq XR have been recalled from U.S. sale due to an increased risk of developing a range of different cancers including pancreatic, colorectal, and lung cancer. The FDA is not recommending special screenings at this time, but does advise patients to discontinue use of the drug and to consult their physicians.

What Is Belviq, How Does It Work, and Who Is It for?

To understand why there is controversy surrounding Belviq, it’s best to understand a bit more about it. Belviq is the name given to lorcaserin hydrochloride. It is a serotonin 2C receptor agonist that tricks the brain into producing a feeling of fullness, reducing appetite. It is also marketed is Belviq XR.

It was developed for and marketed toward people who were obese with a Body Mass Index (BMI) of 30 or greater, and more specifically those with a BMI of 27 or higher that also had a weight-related comorbid condition, like hypertension (high blood pressure), type 2 diabetes, and so on.

Belviq, along with a nutrition plan and exercise, was said to help patients lose at least 5% of their baseline body weight and keep it off. While it may not seem like much, even a slight reduction in weight can reduce a person’s risk for a wide range of illnesses. The drug’s gains seem minimal, but for a small subsection, it was initially believed to be a breakthrough treatment. It was intended that patients would take Belviq for the rest of their lives.

Belviq: The Reason for the Recall

The recall and alarm stem from when the FDA required the manufacturer, Japanese pharmaceutical firm Eisai, to perform a randomized, placebo-controlled, double-blind study: the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients – Thrombolysis in Myocardial Infarction 61 or CAMELLIA-TIMI 61 trial.

The purpose of that study was to determine whether the drug elevated the risk of cardiovascular problems, which was a side effect of the infamous fen-phen, a drug whose heart-related side effects resulted in a massive class action lawsuit.

While the study seemed to indicate the drug had no profound effect on cardiovascular problems, it did find that it elevated the risk of cancer. Of those in the study, 7.7% of individuals who took Belviq developed cancer as opposed to 7.1% of participants taking the placebo. A range of cancer types was reported, and notably included pancreatic, colorectal, and lung cancer.

BREAKOUT: The Difference In Numbers

The study showed that 7.7% of Belviq users developed cancer versus 7.1% of those taking the placebo. Consider two things. 1) If the instances of specific cancers are higher with Belviq, it could indicate that the drug had a hand in causing those. 2) While it may seem insignificant, the 0.6% difference between the two study groups, extrapolated across one million users, would mean 6,000 additional users diagnosed with cancer. When dealing with product faults, the numbers of users are quite large. Even a small percentage represents thousands of people whose lives are adversely impacted.

Should Belviq Ever Have Been For Sale?

When it was approved by the FDA for sale in 2012, Belviq was among several new weight-loss drugs to be approved, and one of the first anti-obesity drugs to get approval in 13 years. For Belviq, the FDA did require a five-year test of the drug’s effects on cardiovascular health – the CAMELLIA-TIMI 61 trial – as a condition of approval. The CAMELLIA-TIMI 61 trial was a post-marketing study, so it did not culminate until 2017.

An evaluation of the study’s results concluded, “the utility of lorcaserin as an adjunctive therapy for diabetes prevention and remission appears to be limited in today's clinical practice for a number of reasons.”

Furthermore, there is evidence the company and the FDA were aware of a cancer risk as far back as 2012. An FDA review document from 2012 noted that a study in rats found Belviq “caused mammary gland tumors in both sexes at clinically relevant exposures, with no safety margin identified for female rats.”

Belviq was also refused clearance for sale in Europe. The original creator of the drug, Arena Pharmaceuticals – which later sold its rights to Eisai – pulled their application to market the drug in the European Union, where it was rejected by the EMA, in 2013. One conclusion read, “In practice, lorcaserin has not been shown to prevent complications of obesity or even lead to substantial weight loss. There is therefore no justification for exposing patients to the risk of adverse effects.”

The mounting evidence points to a drug that may well have been known to be harmful. Warning signs – and even stop signs in the case of the EU – were clear and present. And yet, the drug proceeded to market in the U.S.

Even More Reason to Doubt Belviq

Public Citizen, a consumer watchdog organization, vocalized its own concerns almost immediately upon Belviq’s approval in 2012. Dr. Sidney Wolf, then Director of Public Citizen’s Health Research Group, sent a letter to Dr. Margaret Hamburg, the Commissioner of the FDA at that time. In it, he detailed a very serious concern over the drug’s apparent effect of increasing heart problems by 67% over placebo based on study data already available.

Consumer Reports also stated its doubts about the drug. In their review of Belviq, they observed that the weight loss benefits were not large but the adverse effects of taking the drug could be. They recommended against taking it.

Combine that with a monthly prescription cost that could exceed $300, and it paints a puzzling picture of the decision to prescribe Belviq in the first place. Nonetheless, it was available to the public in 2013.

Next Steps

For those who have taken Belviq for any length of time, speak with your doctor as soon as possible. The drug’s recall means you should obviously discontinue use, but you should consult your physician about your next steps, as treatment plans vary.

The cancers reported vary, but the three most commonly cited are pancreatic, colorectal and lung. Speak to your doctor about your concerns, especially if you’re a long-time user of Belviq.

What Are the Benefits of Filing a Belviq Lawsuit

If you or someone you know has taken Belviq and been diagnosed with cancer, the time to act is now. A cancer fight is a difficult, expensive and often painful experience, and you should not have to shoulder that burden alone. The experienced product liability team at the Law Offices of James Scott Farrin stand ready to help you. Focus on fighting for your health and let us fight for your rights. Call 1-866-900-7078 or contact us at your earliest convenience. Together we can stand up to those who make faulty products.

The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.

The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.