Belviq Recall Cancer Risk

If you or someone you loved took the weight-loss drug Belviq (lorcaserin), you may be concerned about a Belviq recall cancer risk. There have been media reports suggesting that this drug may slightly increase the risk of cancer.

On February 13, 2020, the U.S. Food and Drug Administration (FDA) requested the recall of all forms of Belviq from the market. The agency took this action after reviewing the results of a study showing that people who took lorcaserin for an extended period were more likely to be diagnosed with cancer than those who didn’t.

Pharmaceutical companies release handfuls of new drugs onto the market every year and are responsible for the safety of their consumers.  Chaffin Luhana Belviq cancer lawsuit lawyers believe that Belviq manufacturer Eisai Inc. failed to warn patients and doctors about the dangers associated with its product, which has now severely impacted the lives of thousands of people.

What is Belviq?

Belviq was the first in a new class of drugs called selective serotonin receptor agonists. These help people lose weight by acting on the brain’s neurotransmitters to produce a feeling of satiety. When taking the me drug, patients feel less hunger and can eat smaller amounts of food.  Belviq’s goal, as well as other weight-loss drugs, is geared towards medically defined overweight or obese individuals in an attempt to obtain weight loss in order to subsequently lower the risks of high blood pressure and heart complications.

Safety Concerns Delayed Belviq Approval

Belviq’s approval process began when the original manufacturer, Arena Pharmaceuticals, first submitted a New Drug Application (“NDA”) in 2009.  To supplement this application, Arena included the results from clinical trials on the drug involving 8.500 patients, which showed that Belviq successfully produced significant weight loss and was subsequently safe to use.

However, in October 2010, the FDA got back to Arena on its drug application. The agency noted some safety concerns and stated it could not approve the drug until the issues were resolved.

Namely, some Belviq studies had linked the drug to an increased risk of cancer and tumors in animal subjects—an early indication of the problems that would eventually result in the drug’s recall. One of these studies was conducted as far back as 2007, yet the manufacturer still applied for approval without addressing the risks.

The FDA allowed Arena to review the safety issues and try again. Arena submitted its response in January 2012. The FDA convened a meeting of an advisory committee, which voted 18 to 4 with one abstention that based on the available data, the potential benefits of the drug outweighed any potential risks when used in overweight and obese individuals.  Within its approval, Belviq was to be used specifically in adults with a body mass index (BMI) of 30 or greater (defined as obese), or adults with a BMI of 27 or greater (overweight), and who had at least one weight-related condition such as high blood pressure, type-2 diabetes, or high cholesterol.

The next year, Arena finalized an agreement with Eisai Inc., to market and supply Belviq. In 2016, Eisai became the sole manufacturer worldwide.

Belviq Health Risks Evident Early On

When the FDA approved Belviq in 2012, it did so with one condition—the manufacturer had to agree to conduct another clinical trial to evaluate the risk of heart-related problems. In the original trials, there was some evidence of heart valve damage in people using the medication and there was concern that these problems could become more evident in a large population.

The manufacturer agreed to the condition and began the new trial, which consisted of about 12,000 overweight or obese participants. All of them were required to have either established cardiovascular disease or to be at least 50 years old for men and 55 years for women with type 2 diabetes plus at least one additional cardiovascular risk factor.

Meanwhile, the consumer-advocacy group Public Citizen warned about the risks associated with the drug and predicted it would eventually be withdrawn from the market stating:

“The Food and Drug Administration (FDA) today recklessly approved another diet drug, lorcaserin, the latest in a series of obesity-related pharmaceuticals that pose serious health threats. We expect that as with many of the other drugs, this one will be withdrawn from the market after the agency is forced to confront the many serious adverse health effects, such as heart valve damage, that will be reported.”

Belviq’s Post-Market Clinical Trial

To be analyzed over five years, researchers divided 12,000 patients meeting specific health criteria into two groups for the new study:

1. Group 1 took Belviq 10 mg twice a day.
2. Group 2 took a placebo twice a day.

After about three years, a preliminary safety analysis showed no significant difference between the drug and the placebo when it came to major cardiovascular events like heart attack and stroke. The manufacturer had cleared that safety hurdle.

More significantly, during the trial, 462 (7.7 percent) of the patients treated with Belviq were diagnosed with cancer—including pancreatic, colorectal, and lung cancer—versus 423 (7.1 percent) of the patients taking the placebo.

In other words, those taking Belviq ended up with a higher risk of being diagnosed with cancer than those not taking it. The longer the patients took the drug, the more of an imbalance there was, indicating that the risk may increase with longer-term use.

Belviq’s Recall

Subsequently, on January 14, 2020, the FDA released a Drug Safety Communication, alerting the public that results from a clinical trial assessing safety showed a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).

Finally, the FDA announced on February 13, 2020, that it was requesting the recall of all forms of Belviq from the market “because a safety clinical trial shows an increased occurrence of cancer.” The agency further stated it believed the risks of lorcaserin outweighed its benefits based on its completed review of the trial results.  Patients were directed to dispose of unused Belviq at drug take-back locations or in their household trash and to talk to their doctors about alternative treatments. Doctors were advised to stop prescribing Belviq to patients.

In reviewing the data, the FDA put it another way: there was one additional cancer observed per 470 patients treated for one year. “There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on lorcaserin.”

In their response, Eisai Inc. cooperated with the FDA in withdrawing Belviq from the market but stated that it disagreed with the FDA’s interpretation of the data on the drug’s safety. The company stands behind the product and maintains that its benefits outweigh the risks.

The FDA has not recommended any special medical screening for patients who took Belviq. The agency stated that the increased risk was only seen after extended use of the drug. “As with any individual patient, regardless of prior lorcaserin treatment, standard screening recommendations for cancer should be implemented.”

Is Belviq Dangerous?

Whenever a drug receives FDA approval, it’s expected that its benefits outweigh any risks. Such was not the case with Belviq, however, and several consumer advocacy groups recognized this early on.

In addition to Public Citizen’s warning in 2012, Consumer Reports also warned in 2013 that the drug had “risks galore,” noting that the product label indicated potential side effects like a slowed heartbeat, heart valve problems, painful erections, and for those with diabetes, hypoglycemia, back pain, and cough.

Interestingly, the drug never was released in Europe because of safety concerns. The European Medicines Agency (EMA)—the European equivalent to the FDA—initially rejected the drug after seeing the data from the clinical trials, much as the FDA did. The Committee for Medicinal Products for Human Use (CHMP), which reviews applications for drug approvals with the EMA, evaluated the documentation and formulated lists of questions for the manufacturer.

After assessing the company’s responses, there were still some unresolved issues. The CHMP acknowledged that Belviq had created modest weight-loss in studies, but there was a risk of cancerous tumors, particularly with long-term use.

The CHMP was also worried about the potential risk of psychiatric disorders (like depression) and heart valve problems and was leaning toward the conclusion that the benefits did not outweigh the risks.

Facing an uphill battle, the manufacturer withdrew the application, stating that it would not be able to address all of CHMP’s concerns in time.

What are the Side Effects of Belviq?

The most concerning potential side effect of Belviq is cancer.  The FDA sounded its alarm after reviewing the new supplemental data due to the potential increased risk of cancer coupled with long-term usage.

The types of cancer linked to Belviq in the trial included:

• Pancreatic cancer
• Colorectal cancer
• Lung cancer

Like most all drugs, Belviq has some other potential side effects. Mild ones that were listed on the product label included:

• Headache
• Dizziness
• Fatigue
• Nausea
• Dry mouth
• Constipation

Common Belviq side effects in patients with diabetes included:

• Hypoglycemia
• Headache
• Back pain
• Cough
• Fatigue

Other potential side effects included:

• Impaired attention/memory
• Hypertension
• Stress and anxiety
• Depression/mood problems
• Upper respiratory tract infection
• Peripheral edema (swelling)
• Increased serum prolactin (excess prolactin can cause breast milk production in men and in women who are not pregnant or breastfeeding)
• Decreased hemoglobin
• Euphoria (when taking too much)
• Lymphocytopenia (not enough white blood cells)

How We Can Help if You Have Cancer and Took Belviq

If you or a loved one was recently diagnosed with cancer and you took Belviq for at least six months, you may wonder if the drug had something to do with your cancer diagnosis. This is a perfectly reasonable concern and a question you are entitled to ask. Our dangerous drug lawyers can help you answer that question.

Many other patients are asking similar questions and wondering about their legal rights. It is not uncommon for people to have been harmed by dangerous drugs that they used based on assurances from the pharmaceutical companies that the drugs were safe. These individuals may face increased medical expenses, lost wages, and other damages through no fault of their own.

People who developed lung, pancreatic, or colorectal cancer after taking Belviq for an extended period have the best chance of recovering damages in a Belviq lawsuit. The cancer should have originated in these organs—rather than having spread to them from other organs—and have been diagnosed within seven years of taking either Belviq or Belviq XR (extended-release).

If you or a loved one are facing a cancer diagnosis after taking Belviq, don’t hesitate to call us at Chaffin Luhana. We are now investigating these cases and invite you to call today at 888-480-1123. Your initial consultation is free. It will help if you have copies of your medical records and any details concerning your medical treatments.

If you lost a loved one to cancer that you believed may have been related to the intake of Belviq, don’t wait—it’s best to file a Belviq lawsuit as soon as possible to avoid missing out because of your state’s statute of limitations.