Over a third of Americans are obese. Excess weight causes or contributes to a number of chronic health problems and also increases the risk of premature death. Unfortunately, for many people, it is not easy to lose weight. So, when the Japanese appetite suppressant Belviq (Lorcaserin) became available in the United States, many people began taking the drug, despite the risk of side-effects. Had they known the true danger of Belviq, they might have reconsidered their decisions.
When federal regulators fail to protect people from dangerous drugs, the national Belviq cancer attorneys at Napoli Shkolnik pick up the slack. Our resources make the difference. We partner with top experts in the field who clearly explain a medicine’s flaws to the jury. Additionally, we have considerable experience in this area. We handle dangerous drug claims on a nationwide basis. So, we are fully aware of all the procedural nuances in these matters.
How Does Lorcaserin Work?
Scientifically, Belviq is a selective 5-HT2C receptor agonist. 5-HT2C is a brain chemical commonly associated with appetite and satiety (feeling of fullness). Belviq manipulates this chemical to make patients feel full when they are not. American consumers could choose between a regular and more powerful extended release version of Lorcaserin.
The problem is that the 5-HT2 family of brain receptors are not just associated with appetite. These receptors are located in key parts of the brain, like the cerebellum, amygdala, and hippocampus. They also regulate endocrine levels and overall mood. In other words, Belviq changes the way people feel and does not simply change their eating habits.
Side-effect potential is even higher because Lorcaserin is basically an experimental drug. Even Arena Pharmaceuticals, the drug’s U.S. manufacturer, is not exactly sure how the medicine works.
In clinical trials, Belviq reduced Body Mass Index (BMI) about 5 percent more than a placebo. That’s not exactly an earth-shattering change, but every pound matters to obese individuals.
Belviq’s Approval History
In most cases, the Food and Drug Administration (FDA) approval process takes many years and many millions of dollars. Other drugs, however, receive fast-track approval. That’s true of domestic drugs which meet the definition of a breakthrough drug or treatment.
Foreign drugs are similar, in most cases. Rather than require entirely new clinical trials, federal regulators generally review the available evidence and then make a decision.
In 2009, Belviq’s Japanese producer asked the FDA to approve Lorcaserin for sale in the United States. An advisory panel rejected the application, concluding that the drug’s dangerous side effects outweighed its rather low weight loss potential.
Perhaps most disturbingly, almost half the FDS panelists voted to ignore the risks and approve the drug.
Belvic obtained a new sponsor, Arena Pharmaceuticals, who commissioned some additional tests and resubmitted the application in 2012. This time, the FDA approved the request. However, bureaucrats added some restrictions and monitoring requirements. Some of these restrictions included limited Belviq patients to obese individuals or overweight individuals with at least one related conditions, such as diabetes or hypertension (high blood pressure).
At roughly the same time, the Drug Enforcement Administration (DEA) classified Belviq as a Schedule IV drug. The DEA cited possible hallucinogenic side-effects, because as mentioned, Lorcaserin alters brain chemistry.
That’s not the only possible side-effect. When regulators approved Belviq in 2012, they already knew it was associated with a higher cancer risk, such as:
- Pancreatic cancer,
- Lung cancer, and
- Rectal cancer.
A 2014 study found an increased risk, but the increase was not very significant. A larger, double-blind study released in January 2020 yielded much more alarming results. So, the FDA asked Arena to voluntarily recall the drug, and the manufacturer agreed.
Lorcaserin has also been linked to cardiovascular issues, such as heart attacks and strokes. These risks are especially high for people with certain pre-existing conditions or genetic predispositions.
Your Claim for Damages
The known risk of side-effects is usually not relevant for liability purposes. Typically, manufacturers are strictly liable for the damages their dangerous drugs cause. Negligence, or lack thereof, does not matter. The specific product defect could be:
- Design Defect: Many drugs, like Belviq, take a shotgun approach. Rather than target specific body chemicals that have specific functions, the medicine targets a large group of chemicals, and doctors then hope for the best.
- Manufacturing Defect: These defects are especially common in foreign drugs and medical devices. For example, some hip implants sold in the United States came from plants in China. As a result, these gadgets have high levels of heavy metals, making a dangerous device even more dangerous.
Negligence is highly relevant for damages purposes. Many drug makers, like Arena, relentlessly press regulators to approve drugs which the manufacturers know are unsafe. Frequently, juries award significant punitive damages in these cases. Money is the only language these drug makers speak. So, significant punitive damages is the only way to deter these companies from such reckless behavior.
Damages in dangerous drug cases also include compensation for economic losses, such as medical bills. That’s especially important in cancer cases. Cancer survival rates have increased significantly since the 1990s, but cancer treatment costs have increased even more. Victims need significant financial resources to combat this disease.
Belviq could cause cancer and a number of other dangerous or fatal side-effects. For a free consultation with an experienced Belviq cancer attorney, contact Napoli Shkolnik PLLC. After-hours visits are available.