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It was once touted as a new option for those who are obese, overweight, or suffering from weight-related medical conditions. However, many people that were prescribed Belviq or Belviq XR to help them lose weight in a long-term clinical trial reported feeling unwell years into the study. In fact, many users reported that the drug made them feel like they had cancer. Sadly, they did.
In February 2020, the maker of Beviq and Belviq XR—Japanese drug manufacturer Eisai—announced that it was voluntarily pulling the drug from the market upon the request of the Food and Drug Administration (FDA). The FDA not only felt that the risks of this drug were severe enough to request an immediate withdrawal from the market, but also to state that individuals taking the medication should stop doing so immediately. If you were prescribed this medication, and you have been diagnosed with cancer, an experienced Belviq injury attorney can help you understand your legal options.
Belviq, with the active ingredient lorcaserin, is a weight loss drug that was prescribed to obese or overweight individuals with at least one weight-related medical condition. Lorcaserin belongs to a class of drugs called serotonin receptor agonists, which produce an increased feeling of fullness that causes users of the drug to consume less food.
The drug was said to not only help those individuals lose weight, but also to help prevent them prevent gaining it back. The medication was provided in tablet form or extended-release tablet to be taken by mouth, with or without food, twice a day, as part of a larger weight loss plan that also included exercise and a reduced-calorie diet.
In addition to an increased risk of certain types of cancer, Belviq has a long list of other known side effects, including:
Being overweight means weighing more than what is considered a healthy weight for one’s height, body frame, and age. Obesity means having too much body fat. Of the two, obesity is considered more dangerous, as it can lead to dangerous medical conditions, such as diabetes, heart disease, stroke, arthritis, and some cancers. Losing bodyweight—even as little as 10 to 20 pounds—can delay many of these conditions.
As with most medications, patients and their physicians are asked to compare the benefits to one’s overall health of taking a drug as opposed to the risks of additional medical issues that are posed by the drug. Eisai noted in its announcement of the withdrawal of Belviq from the U.S. market that the drug has been evaluated in more than 30 clinical trials over 15 years, involving more than 22,000 patients, and that the company still believes that the drug has a positive risk-benefit profile for patients.
According to the U.S. Food and Drug Administration (FDA), when Belviq was approved for use in the U.S. in 2012, the manufacturer was required to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. The study involved monitoring around 12,000 patients over five years. When evaluating the results of the study, the FDA discovered that more patients who were taking the drug were diagnosed with cancer than those who were taking a placebo. Eisai reported that the results of that evaluation were that 7.7 percent of patients taking Belviq were diagnosed with cancer, in comparison to 7.1 percent of the placebo group.
The types of cancers that Belviq is suspected of increasing the risk of include:
Belviq may increase a user’s risk of other cancers, as well, but the FDA did not specifically identify additional types.
Why didn’t the FDA know about the increased risk of cancer before it approved this drug for use in the U.S.? What is the approval process for new drugs? These are common questions when there is a drug recall or—as in this case—a voluntary withdrawal of the drug from the market upon recommendations from the FDA.
The drug approval process includes:
The clinical trials involved in the process can take several years to complete. However, after all that time, the FDA states that it will provide an answer to the New Drug Application within 60 days of its submission.
Manufacturers and distributors of prescription drugs have the responsibility to ensure that their drugs are safe when used as instructed. Failure to do so can make them liable for the injuries or illnesses that individuals using the drug suffer.
Injuries and illnesses caused by prescription drugs generally occur in one of two ways:
One reason that the FDA requires so many trials before approving a drug for use is so that it can review the side effects suffered by individuals involved in the trials and determine if the risk of the side effects outweighs the benefit of the drug.
Individuals who have been injured or contracted an illness due to the use of a prescription drug can file a product liability lawsuit against the drug manufacturer or distributor. To ensure a successful outcome in this lawsuit, the claimant must show that the manufacturer or distributor knew about—or reasonably should have known about—the defect or dangerous side effect but failed to warn others.
If a plaintiff can prove that the manufacturer or distributor knew about the defect or dangerous side effect and made an effort to conceal that information, he or she may receive punitive damages. Punitive damages are compensation that is awarded beyond the expenses and life-impacts suffered by the claimant, and these damages are designed to punish a defendant for particularly egregious behavior.
If you or someone you love took Belviq or Belviq XR (extended-release) and has subsequently been diagnosed with cancer, you should determine your eligibility to seek compensation through a product liability lawsuit. This compensation is designed to not only help you with the medical expenses and lost wages that you have suffered as a result of your diagnosis, but also to assist with some of the many impacts you may also suffer as a result of the disease, including emotional and physical pain and suffering.
Drug companies often employ high-powered attorneys to protect their interests, while leaving their victims to suffer. You will want to have a knowledgeable attorney on your side to fight for your rights. An experienced product liability attorney can provide you with answers to your legal questions and guidance as to how cases like this work.
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