Nuplazid, a new medication to treat Parkinson’s disease has been linked to a high number of patient deaths. The FDA has been made aware of as many as 700 deaths linked to the drug and the number is growing. The Kentucky dangerous drug attorneys of Gray & White have begun investigating cases concerning patients taking Nuplazid who shortly after taking the prescribed medication.
Nuplazid, generically known as pimavanserin, is the first and only FDA-approved drug used to treat patients with Parkinson’s disease that suffer from debilitating psychosis, specifically delusions, and hallucinations. Since the FDA approved the drug for market use two years ago, a shocking number of adverse effects, including over 700 deaths, have been reported. Many experts, including FDA’s lead medical reviewer on Nuplazid, have voiced their reservations about the drug and its benefits when weighed against its risks. Unfortunately, it appears the desire of the manufacturer to bring this drug to market and start making profits outweighed the concern being expressed by many physicians and researchers involved in ensuring the safety of the drug.
As with many of the dangerous drug cases our firm’s handles, the early warning signs were present but ignored by drug manufacturers. It is the classic scenario of profits of people. The drug was approved by the FDA’s reliance on a single clinical trial indicating minimal treatment effect. Moreover, it was only approved after 3 previous clinical trials failed to show any benefit to the patient. This was a rush to market of a very dangerous drug. Parkinson disease sufferers deserve better from the drug companies.
More Information About Parkinson’s Disease
Parkinson’s disease is a neurodegenerative disorder that affects nerve cells, primarily neurons responsible for producing dopamine, in a specific section of the midbrain called the substantia nigra. Dopamine is responsible for transmitting signals between the different sections of the brain that control the coordination of muscle movement. Symptoms of Parkinson’s disease gradually develop and normally do not show until later in the course of the disease. Symptoms of Parkinson’s disease include motor abnormalities, such as tremors, bradykinesia, gait and balance problems, and limb rigidity, as well as neuropsychiatric symptoms, such as delusions, hallucinations, dementia, depression, and apathy.
The neuropsychiatric symptoms often impact those with Parkinson’s disease more than the motor symptoms. Of the approximate one million Americans suffering from Parkinson’s disease, up to 50% of them experience symptoms of psychosis. Psychosis symptoms most often consist of paranoid delusions, visual hallucinations, or sensory disturbances; patients can experience a combination of several psychosis symptoms. All of the symptoms worsen over time. The most frequently reported symptoms, which typically occur in the evening due to low stimulation, are visual hallucination of people, animals, or inanimate objects. In addition to visual hallucinations, though less common, include auditory, tactile, olfactory, and gustatory hallucinations.
The disease itself is not fatal; however, Parkinson’s disease complications can be very serious and potentially lead to death. There is little known about the cause of Parkinson’s disease, and, unfortunately, there is no known cure. Complications from Parkinson’s disease is rated as the 14th cause for death by the Centers for Disease Control and Prevention (CDC).
While complications of Parkinson’s disease can potentially be fatal, it is possible for a person with Parkinson’s disease to live a good quality life. Because Parkinson’s disease causes the dopamine-producing neurons to degenerate which results in low levels or missing dopamine in the brain, people with Parkinson’s disease can work with their doctors to treat their symptoms with dopaminergic medications.
As of now, all available treatments for PD are used to improve symptoms but do not slow down the process of the disease. Scientists are working to identify biomarkers for Parkinson’s disease in hopes to be able to diagnose Parkinson’s disease earlier in patients and create more specific treatments to halt the disease process.
What Is Nuplazid? How Does It Treat Parkinson’s Disease?
Many patients and family members of those suffering from psychosis as a result of Parkinson’s disease opted to use Nuplazid for the potential relief of the patients’ symptoms. Made by Acadia Pharmaceuticals, Nuplazid was marketed as offering “real help for a real part of Parkinson’s disease” as the first and only FDA approved drug designed to decrease delusions and hallucinations caused by Parkinson’s disease. Nuplazid instructs patients to take two 17-mg tablets a day. Nuplazid’s websites states that while some patients may see a reduction in hallucinations and delusions as soon as two weeks, other patients may not feel the full effect of the drug until up to 6 weeks. Nuplazid contains a boxed warning for patients 65 years or older suffering from dementia-related psychosis stating that the usage of Nuplazid causes an increased chance of mortality.
Serious Side Effects Were Noted During The FDA Approval of Nuplazid
Nuplazid was designated as a “Breakthrough Therapy,” which is an FDA process that allows for the development and review of certain drugs that show “substantial improvement” over other available drugs to be expedited.
An advisory committee, responsible for recommending or discouraging the approval of the drug based on its potential benefits compared to its risks for its intended party, voted 12-2 and recommended that the FDA approve Nuplazid. The vote was largely based on a 6-week clinical trial of about 200 patients aged 40 years and older, in which the responses patients had to taking Nuplazid daily were measured against the responses patients had from taking a placebo daily. Dr. Paul Andreason, the lead medical reviewer for the FDA, noted that the patients that were taking the Nuplazid experienced serious outcomes, including death, at more than double the rate of those that were taking a placebo.
In addition, three clinical trials completed prior to the former mentioned did not show that Nuplazid was effective and showed similar risks. Some of the committee members that voted in favor of the drug also expressed concern for the drug; however, the fact that there is no other safe and effective drug on the market convinced them to vote in favor for the drug in hopes that it will provide benefits to some of the patients and families affected.
Nuplazid Injuries Began Almost Immediately After the Drug Went to Market
Less than a year after Nuplazid became available in the market, the Institute for Safe Medicine Practices (ISMP) found 2,236 reports of adverse effects associated with Nuplazid. Of those reports, hallucinations, ineffective drug, confusional state, and death were the most frequent reports. Weeks after the ISMP shared its findings, the stock price of Acadia dropped over 20%.
Acadia claims that the large reports of adverse effects—specifically concerning deaths—are to be expected, as psychosis is typically seen in the later stages of Parkinson’s Disease when patients are already at a high risk of death. Acadia adds that because they distribute Nuplazid to specialty pharmacies, which means that the pharmacies have more contact with patients and caregivers, that Acadia is more likely to receive reports, which it must pass on to the FDA.
Currently, Acadia is working to get the medication approved for a larger patient population to include patients who have dementia-related psychosis. The FDA also designated the drug a “Breakthrough Therapy” for this potential use, which means it too will have a quicker review process.
Our Lawyers Are Accepting Nuplazid Lawsuits Now
Gray & White Law is investigating Nuplazid lawsuits in Kentucky and across all 50 states. If you or someone you love has suffered any of these severe side effects, please contact our attorneys for a free, no-obligation consultation:
- Irregular Heart Beat
- Weight Loss
- Poor treatment of psychosis
It is reported that as many as 8.1% of patients taking Nuplazid will experience one or more of these serious side effects. According to the Institute for Safe Medication Practices, Nuplazid was linked to hundreds of deaths in the first few months after its launch to the public. The Institute for Safe Medication Practices issued a statement calling into question the efficacy of the drug and the high risks associated with its use warning people that it might do more harm than good for Parkinson sufferers. A recent report by the FDA indicated that Nuplazid was the only drug being taken by more than 500 cases in which patients died while taking the drug.
Contact the Personal Injury Attorneys of Gray & White Today for Help Now
If your or a loved one has suffered hallucinations or died while taking Nuplazid you may have a claim for damages against the drug manufacturer. Gray & White Law has a long history of success in fighting for the rights of clients injured by dangerous drugs. We have the experience, knowledge and resources to fight the drug companies. Contact us today for a FREE CONSULTATION.