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Medicines are essential in treating diseases, but some can have adverse side effects that outweigh their benefits. Nuplazid, manufactured by Acadia Pharmaceuticals, Inc., is one such medication.
Nuplazid has been associated with life-threatening side effects rather than effectively treating Parkinson’s disease in patients.
This can lead to Nuplazid lawsuit, as patients and their families seek compensation and justice for the harm caused by the medication.
Before we explore the lawsuit, let’s understand what Nuplazid is and why it’s prescribed.
What is Nuplazid?
Nuplazid (pimavanserin) is a medication primarily used to treat hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Parkinson’s disease is a neurological disorder that primarily affects movement, but it can also lead to psychiatric symptoms in some patients.
Psychosis in Parkinson’s can cause hallucinations and paranoia, making life difficult for patients and their families. Hallucinations make people see or hear things that aren’t really there.
Nuplazid was approved by the U.S. Food and Drug Administration (FDA) in 2016. It works as a selective serotonin inverse agonist and antagonist at serotonin receptors. Nuplazid does not have a generic alternative and is solely available as a brand-name medication.
Studies Linked to Nuplazid
Nuplazid Efficacy Study
In a Nuplazid efficacy study involving 199 patients, Nuplazid was found to reduce the severity of the Parkinson’s symptoms compared to its placebo. Patients taking Nuplazid showed improvement as early as the second week of treatment, with even greater reductions seen at weeks 4 and 6.
The study included patients with PD-related hallucinations and/or delusions, some with dementia and some without. Results showed that Nuplazid was effective in improving symptoms, with fewer patients experiencing worsening or no change compared to those on placebo.
Nuplazid did not affect daily activities at Week 6, which is important for people with Parkinson’s disease. Nuplazid helps reduce hallucinations and delusions in Parkinson’s disease patients, showing improvements as early as two weeks into treatment and continuing over six weeks. However, it doesn’t affect motor function or daily activities.
Safety Tolerability Study
According to the safety tolerability study, elderly people with dementia-related psychosis who take Nuplazid have an increased risk of death. Studies have shown that some patients experienced hallucinations, urinary tract infections, and fatigue more frequently with Nuplazid compared to a placebo.
Additionally, Nuplazid can prolong the QT interval in the heart, leading to life-threatening heart rhythm abnormalities. Other side effects include orthostatic hypotension, sedation, nausea, confusion, constipation, and gait disturbance.
Is Nuplazid Linked to Death?
According to CNN report, Nuplazid is associated with serious adverse effects, including 244 deaths between 2016 and 2017. When Nuplazid was being considered for approval, there was hope that it could provide relief for these symptoms. However, concerns arose about the drug’s safety. During clinical trials, some people experienced serious adverse effects, including death, at a higher rate than those who took placebo.
After Nuplazid was released to the market, reports of adverse effects continued to pile up, including more than 700 deaths. Experts worry that Nuplazid might have been approved too quickly, without enough evidence on its safety. They believe that more research is needed to fully understand the risks and benefits of the drug.
Despite these concerns, the company that makes Nuplazid insists its benefits outweigh the risks, especially considering the lack of alternative treatments for Parkinson’s psychosis.
The Institute for Safe Medication Practices presented a review in November that revealed the dangers of the Nuplazid drug. It explains that Nuplazid is not so effective, and it might even make things worse for some people.
One of the main treatments for Parkinson involves increasing dopamine levels in the brain, but this can sometimes cause hallucinations. Hallucinations can happen in diseases like Parkinson, where certain brain cells are lost over time. The common treatment usually blocks dopamine, which does not make any sense because dopamine is already lacking in these patients.
Pimavanserin uses a different approach to treating hallucinations. While other drugs targeted dopamine, Nuplazid aimed at serotonin receptors. Nuplazid is supposed to help with hallucinations, especially in Parkinson’s patients. But it hasn’t shown any benefits in clinical trials, and experts suspect its effectiveness.
Despite the concerns, the FDA advisory committee recommended approval, and the drug was approved in the US. Many health professionals reported that the drug didn’t work, and there were numerous reports of hallucinations and confusion.
In response to the concerns, the company suggested that the drug needs some time to show its full potential and that the deaths were not higher in their new trial for Alzheimer’s patients.
While pimavanserin offers a new approach to treating hallucinations, its effectiveness and safety remain uncertain, especially when used in combination with other drugs.
Black Box Warning on Nuplazid
In September 2018, the FDA reviewed reports of deaths and serious side effects associated with Nuplazid. They found no new safety concerns and concluded that the benefits of the drug outweigh its risks for patients with Parkinson’s disease psychosis.
Nuplazid, along with other antipsychotics, carries a boxed warning about the higher likelihood of death in elderly patients with dementia-related psychosis. The FDA remains active in tracking adverse events linked to Nuplazid.
On September 18, 2023, the FDA updated the label for Nuplazid to clarify its use in treating hallucinations and delusions in patients with Parkinson’s disease, with or without dementia. This means that Nuplazid can now be prescribed for those experiencing Parkinson’s-related psychosis, expanding treatment options.
Why to File Nuplazid Lawsuit?
Several Nuplazid lawsuits have been filed against the manufacturer of Nuplazid, alleging that the drug caused severe side effects and failed to provide adequate warning about its risks.
If anyone you know took Nuplazid and experienced adverse side effects or died from it, you can sue the manufacturer of the drug. The lawsuit may offer a path to seeking compensation for their injuries and losses. If you are thinking about legal action, contact a Nuplazid lawsuit lawyer.
Check out our blog to stay up-to-date with the latest information and any developments related to the Nuplazid lawsuit.
