Belviq Weight Loss Drug Recall: Do You Have a Case?

Doug Mann

When the FDA approved the weight-loss drug Belviq (active ingredient lorcaserin) in 2012, nearly 35% of the U.S. adult population was obese. When adults who were overweight but not obese were added, that number jumped to nearly 70%. Adult obesity increases the risk of premature death, so physicians and patients alike had reason to welcome the new option. 

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Table of Contents
  1. Weight Loss Drugs Prior to Belviq
  2. Belviq Approval and Launch
  3. Why Did the FDA Request Withdrawal of Belviq? 
  4. Belviq Lawsuits

Obesity is also associated with a wide range of other medical problems, including an increased risk of: 

  • High blood pressure
  • Heart disease
  • Sleep apnea
  • Asthma
  • Joint problems
  • Gallstones and other gallbladder problems
  • Stroke
  • Depression
  • Certain types of cancer

Weight Loss Drugs Prior to Belviq

The history of weight loss drugs in the US had been shaky, with 90s-era fen-phen products being removed from the market, and then the FDA recommending that patients discontinue use of Meridia in 2010. Both products had been linked to cardiac problems.

Because of this history, some medical experts were concerned that Belviq would also increase the risk of cardiac issues, particularly the development of heart valve problems. The FDA initially denied the approval of Belviq, saying the benefits of the drug did not outweigh the risks. In clinical trials, most patients had seen limited weight loss–between 3% and 5% over time. That meant someone who started taking Belviq at 200 pounds might only be able to expect to lose six to 10 pounds over a period of months to two years. 

Belviq Approval and Launch

The drug was ultimately approved only for patients who were obese or who were overweight and suffering from related medical conditions such as hypertension or diabetes. Belviq was intended to be used in combination with diet and exercise, and worked by making the patient feel full. The drug was marketed in two formulations, Belviq and Belviq XL, an extended-release version.

When the drug launched in the U.S. in 2013, sales were disappointing. The market for Belviq may have been affected by lingering distrust of diet drugs, the small amount of weight the average patient could be expected to lose, and the high cost of the drug. Belviq did gain some traction–by the third quarter of 2014, the company claimed to be averaging 5,000 new prescriptions per week.

But, sales never reached projected levels. Less than four years after Belviq hit the U.S. market, Japanese pharmaceutical company Eisai acquired all rights to market the drug from U.S.-based Arena Pharmaceuticals. And, in February of 2020, less than eight years after initial approval, the FDA requested that the company voluntarily withdraw Belviq from the market. 

Why Did the FDA Request Withdrawal of Belviq? 

In February of 2020, the FDA requested that Eisai voluntarily remove Belviq from the market after reviewing data from a safety clinical trial. The trial data revealed that study participants who took the drug were more likely to be diagnosed with certain types of cancer than those who received a placebo. These included colorectal cancer, pancreatic cancer, and lung cancer, among others.

Though the difference in the overall risk of cancer was relatively small–7.7% versus 7.1%–the FDA concluded that the risks associated with the drug outweighed the benefits. 

Belviq also had several known side effects, including: 

  • Headaches
  • Dizziness
  • Nausea
  • Constipation
  • Fatigue
  • Racing heart
  • Memory problems
  • Low blood sugar

The company did submit a request for voluntary withdrawal as the FDA requested, while publicly stating that they disagreed with the risk-benefit analysis. The FDA recommended that people currently taking Belviq stop, and that medical providers should stop prescribing the drug, and those who had prescribed the drugs should contact patients to advise them to discontinue use and to warn them about the increased cancer risk. 

Belviq Lawsuits

Since the drug was recalled in 2020, people around the country have filed lawsuits alleging that Belviq caused or contributed to their cancers. The claims are generally based on the assertion that the manufacturer knew or should have known that the drug had not been adequately tested, and that they failed to warn patients and their physicians of the possible risks associated with the drug. 

One key piece of evidence involves studies conducted on mice and rats prior to the FDA submission. This testing showed that mice and rats were more likely to develop several types of cancerous tumors after exposure to high doses of the medication. The Committee for Medicinal Products for Human Use (CHMP) cited these studies in recommending against the approval of Belviq in Europe in 2013.

In 2021, several plaintiffs suing Belviq in different federal courts around the country joined in a petition to consolidate the cases into multi-district litigation (MDL). Transferring the cases to MDL would have streamlined the process, but the court denied the request. The denial was based in part on the small number of cases pending at the time in federal court, and also partly on the differing factual issues from case to case. That means that unless a class is certified or another MDL petition succeeds as the number of cases grows, each Belviq case will proceed separately. 

Damages in Belviq Lawsuits

The damages available in a Belviq lawsuit will depend on a variety of factors, and the litigation is too new for there to be sufficient data to offer a clear expectation of the value of a Belviq cancer suit. However, an experienced product liability attorney can offer an assessment of the type of damages that may be available in a particular case.

An expert tip from Doug Mann

Depending on the specifics of the case, a Belviq user who has been diagnosed with cancer and is able to establish that the drug caused or contributed to the cancer may be able to recover: 

  • Medical and related expenses
  • Lost wages and anticipated lost future earnings
  • Intangible damages such as pain and suffering and lost enjoyment of life

In some cases, punitive damages may also be available. 

To learn more about whether you may have a Belviq cancer claim and what type of compensation may be available to you, contact an experienced defective drug attorney as soon as possible. Your time to file a claim is limited, and determining when the clock started running can be complicated, so call 937-222-2222 or click in the lower right-hand corner to chat right away.

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