Ten years ago, Belviq was one of the first weight loss drugs approved by the Food and Drug Administration (FDA) since the 1990s. The FDA had already denied the application to allow Belviq sales in the US when the developer of the drugs submitted new data showing its safety.
Still, Belviq was an extremely controversial drug when it was first released. The FDA required the drug’s makers to engage in new clinical trials to prove the drug’s safety.
Unfortunately, a trial required by the FDA as a condition of it approving Belviq proved the drug was unsafe. Eight years later, Belviq’s makers removed the drug from the market at the request of the FDA. The FDA advised patients to stop taking Belviq immediately.
Here, we will answer many of the questions you probably have about Belviq, such as:
- What about the research convinced the FDA to ask for a recall?
- What do doctors think about the research that caused the recall?
- What active lawsuits are there against the pharmaceutical companies?
- Where can you find more information about Belviq?
Belviq’s History as a Weight Loss Drug
Arena Pharmaceuticals developed the drug sold under the name Belviq. Eisai Inc. manufactured Belviq. Before Belviq, there was only one long-term weight loss drug available in the US — Xenical. Most patients didn’t take Xenical for long because of its harsh side effects. The FDA approved Xenical in 1999.
Belviq activates a serotonin receptor in the brain that reduces hunger signals. As a result, patients eat less and lose weight. Since it acts on serotonin receptors, it works in a way similar to many antidepressants.
Why Was the FDA Concerned About Belviq?
The FDA turned down Arena’s application to approve Belviq in 2010. Arena submitted new data. On June 27, 2012, the FDA approved Belviq based on the new data, but required additional clinical trials as a condition of approval.
According to the New York Times, the FDA’s primary concern was that Belviq could damage heart valves since it worked in the same way as fenfluramine. That drug was a part of Fen-Phen, the weight loss drug that was withdrawn from the US market in 1997 because it damaged patients’ heart valves.
The FDA had been requiring post-approval clinical trials for weight loss drugs since Meridia’s manufacturer recalled it in 2010 for causing coronary issues in patients. Belviq’s makers would have to conduct post-approval trials to prove Belviq didn’t cause heart issues.
According to the New England Journal of Medicine, another issue had arisen with Belviq during the approval process. In 2009, tests with rats showed Belviq was likely to cause tumors to grow. That’s part of the reason for the FDA’s denial of the Belviq application in 2010.
In 2012, Arena submitted new data to show that what happens in rats doesn’t necessarily happen in humans. We’ll take a more in-depth look at the research in a special section below.
Is Belviq an Effective Drug?
In trials, the average weight loss after one year for patients using Belviq was 5.8%. For some patients, it was more effective than others. In the trials, 23% of patients lost 10% or more of their weight. It’s hard to call 5.8% per year effective.
As a general rule, weight loss drugs are for people with a body mass index (BMI) over 30 because that’s the obesity level. Over 25 is overweight but not obese. So, how long would it take someone that has a BMI of 36 to no longer be overweight if they’re achieving average results from Belviq?
For a male weighing 250 pounds and five-feet ten-inches tall, they would have a body mass index (BMI) of 35.9. The weight a five-feet ten-inches tall male needs to reach to have a BMI of 25 is 174 pounds. The table below shows how long it would take this person to reach 174 pounds if they’re achieving the average results while taking Belviq.
|Years||Percentage Lost||Weight Lost||Weight|
|After 1 Year||5.80%||14.50||235.50|
|After 2 Years||5.80%||13.66||221.84|
|After 3 Years||5.80%||12.87||208.97|
|After 4 Years||5.80%||12.12||196.85|
|After 5 Years||5.80%||11.42||185.44|
|After 6 Years||5.80%||10.76||174.68|
Six years is a long time to take Belviq — especially when you consider the side effects.
Reported Side Effects From Taking Belviq
According to the Mayo Clinic, there are many common side effects for Belviq. In the “more common” category, the side effects include:
- Bladder pain
- Bloody or cloudy urine
- Blurred vision
- Body aches or pain
- Cold sweats
- Cool, pale skin
- Difficult, burning, or painful urination
- Difficulty with breathing
- Ear congestion
- Fast heartbeat
- Frequent urge to urinate
- Increased hunger
- Loss of voice
- Lower back or side pain
- Nasal congestion
- Pounding in the ears
- Runny nose
- Slow or fast heartbeat
- Slurred speech
- Sore throat
- Swelling of the breasts or breast soreness in both females and males
- Unexpected or excess milk flow from the breasts
- Unusual tiredness or weakness
The side effects aren’t the only concern. Belviq has dangerous interactions with many common drugs — including the most common antidepressants and anti-anxiety medications. But there’s another risk that’s much larger than these side effects. And unlike side effects that sometimes subside over time, this risk gets worse. We’ll go into more detail in the research section below.
Names Belviq Goes By
Belviq and Belviq XR (extended release) are the brand names. The generic name for this drug is lorcaserin or lorcaserin hydrochloride.
What Clinical Trials of Belviq Show
As mentioned earlier, as a condition of approval, the FDA required the pharmaceutical companies to conduct clinical trials after the drug came to market to ensure Belviq didn’t cause damage to the heart.
From 2014 through 2018, researchers conducted the CAMELLIA-TIMI 61 trial. This trial included 12,000 participants, with half receiving Belviq and half receiving a placebo. The trial found no evidence Belviq affected the heart. But it found something else.
Remember, there was also the issue of many tumors growing in rats that were given Belviq, but cancer wasn’t the focus of the study. The incidences of cancer in the Belviq group was 7.6%. In the placebo group it was 7.1%. That’s not a big difference. But there is more to consider.
In the Belviq group, .9% died from cancer. In the placebo group, only .6% died from cancer. That is a 50% higher risk in the Belviq group (.9 is 150% of .6). But it’s still only a .3% difference. The key issue with Belviq and cancer was the increase in cancer diagnosis in the Belviq group versus the placebo group over the term of the clinical trial.
At the 180-day point in the study, the cancer rate for the Belviq group was only about 10% higher than the rate for the placebo group. And, for the first couple of years, the cancer rate for the Belviq group fluctuated in the 10% to 20% range above the placebo group.
At approximately 800 days, the Belviq group started a steep increase. By 900 days, its cancer risk was approximately 35% higher than the placebo group. Based on the variance, this was too much to be explained by random fluctuations.
Nine hundred days is about two and a half years. Remember the table above shows someone with a BMI of 36 that gets average results from Belviq will need to take it for six years to no longer be overweight. But after only two and a half years, their risk of cancer has risen by almost 35%. What happens to cancer risk after six years?
The Belviq group had much higher rates of the deadliest cancers. According to WebMD, the four deadliest cancers are:
- Lung Cancer
- Colorectal Cancer
- Breast Cancer
- Pancreatic Cancer
While the comparison of breast cancer between the Belviq group and the placebo group is almost the same, there were major differences in the other cancers in the top four.
Incidences of lung cancer were 60% higher in the Belviq group versus the placebo group. Colorectal cancer was almost twice as common in the Belviq group as the placebo group. Pancreatic cancer was eight times more likely in the Belviq group than in the placebo group.
We won’t know if the cancer rate continues to rise or why it causes certain types of cancer because it’s too risky to perform another trial for this drug.
While all drugs have some risk — especially weight loss drugs– it was too dangerous to continue to allow Belviq sales in the US. By 2020, there were too many alternatives on the market with lower risks to continue allowing Belviq prescriptions in the US.
The Belviq Recall
After the FDA spotted the cancer risk from the trial data, it made the decision that the risk of taking Belviq outweighed the potential benefits of the drug.
On February 13, 2020, the FDA asked Eisai , Inc. to withdraw Belviq from the market. Eisai is the manufacturer while Arena developed Belviq. Eisai complied with the FDA’s request. The FDA urged all patients to stop taking Belviq and contact their healthcare providers about using another weight loss drug.
It’s interesting that the Belviq recall is only a Type III recall, meaning it’s a recall of the least concern by the FDA. Philips’ CPAP devices received a Type I recall, which is the FDA’s highest priority recall.
But the FDA recommended Philips CPAP users to talk to their doctors before deciding to stop using their CPAP. With Belviq, the FDA advised patients to stop taking the drug immediately and then talk to their doctor about another option.
And, it gets more extreme with Belviq. The FDA advised patients to mix the pills with dirt or cat litter. Then the patients are supposed to seal that mixture in a container. Only after this process are the Belviq users supposed to put their Belviq, along with their sealed container and cat litter, into the trash.
The FDA’s advice regarding Belviq seems excessive for a drug that’s only the subject of a Class III recall.
What Do Doctors Think of Belviq?
Doctors are unhappy that the pharmaceutical companies didn’t warn them about the potential for Belviq to cause cancer. Some doctors look at the superficial evidence without taking a deep dive into the results of the research. These doctors think the evidence wasn’t sufficient to remove Belviq from the market.
The doctors who have looked closely at the research know that over the long term, the risk of cancer rises significantly for patients taking Belviq. Regardless of doctors’ opinions of the research, the consensus is that there are safer options now, and the evidence is enough to change their patients to another drug.
Lawsuits Against the Makers of Belviq
When Belviq’s makers recalled it because it causes cancer, Belviq patients were understandably upset. When these patients learned the Belviq makers knew about the risk before they sold the drug to the first patient, people were furious.
In 2020, patients filed the first cases against Belviq makers, Arena and Eisai. In the spring of 2022, the Belviq defendants had their motions to dismiss denied in several cases. This sent the defendants scrambling to settle.
The primary issues in these cases are the Belviq defendants’ failure to warn patients and doctors of the cancer-causing risk of Belviq and their failure to change the design of Belviq after they knew of the risk. Since the defendants knew of the cancer risk with Belviq before the FDA approved it, had they taken action before bringing Belviq to market, Belviq wouldn’t have hurt anyone.
Now that there are many adverse rulings against the Belviq defendants, they are trying to negotiate a global settlement with all the Belviq patients that have filed lawsuits against them. Many cases have halted until November while the parties to the Belviq lawsuits attempt to reach an acceptable settlement.
Why did the Belviq defendants ever put the product on the market? We know the answer to that question. The Belviq defendants put their profits ahead of your lives. Even after the cancer-causing potential for Belviq reached the public, the defendants preferred to fight the case for two years before the first settlements. Again, they put their money ahead of your lives.
If you have been suffering from cancer because of Arena and Eisai’s bad acts, you need compensation from those companies. They need to pay for expenses like medical bills. They need to cover lost income because of your illness. And they need to compensate you for all the pain and suffering you’ve endured as a cancer patient.
You need to be a part of any global settlement to protect your rights to compensation. These negotiations may end in November, so time is of the essence.