Nuplazid Side Effects- Parkinson’s Lawsuit & Complications | Death & Heart Attack
Nuplazid side effects are a serious matter that require the attention of top medical providers as well as defective drug lawyers. Nuplazid is a medication that is used as an anti-psychotic drug, treating symptoms associated with Parkinson’s disease. It also has the possibility to treat schizophrenia and major depressive disorder. Nuplazid belongs to the atypical antipsychotic class of medications and has recently been approved by the FDA. However, numerous people who have been prescribed and have been taking Nuplazid have died. If you are interested in filing a Nuplazid lawsuit, contact a Nuplazid lawsuit attorney. It is alleged that Nuplazid can cause death by heart attack, which has caused the FDA to undertake further study. As a result, Acadia Pharmaceuticals, the maker of Nuplazid, faces the prospect of numerous lawsuits attempting to hold it liable for deaths and other complications. If you or a loved one has suffered a heart attack or any other complications while taking Nuplazid, you should contact a Nuplazid side effects lawyer immediately to discuss your case.
Update- 8-8-2022- “Following thousands of reported side effects from Nuplazid, a blockbuster antipsychotic drug that was fast tracked through the FDA approval process a few years ago, federal health regulators have rejected an application by Acadia Pharmaceuticals to expand use of the drug to treat symptoms of Alzheimer’s disease psychosis.” About lawsuits
4-5-2021- “Acadia Pharmaceuticals’ plan to expand use of its anti-psychosis drug to dementia patients has been rejected by the FDA, but the company pins the blame squarely on the regulator.The FDA and the San Diego-based company had agreed on the clinical trial design and the benchmarks that study needed to hit in order to support approval of the drug, pimavanserin, as treatment for psychosis in a broad group of dementia patients. Despite hitting those marks, the FDA’s rejection letter cited analysis of subgroups that were not part of the agreed upon plan, according to Acadia. CEO Steve Davis said the complete response letter (CRL) was the first time the company heard that the FDA’s division of psychiatry wanted subgroup analyses” Med City News
9-11-2020- “Adjunctive treatment with the atypical antipsychotic pimavanserin (Nuplazid) succeeded in treating negative symptoms of schizophrenia, according to the ADVANCE study. In the 26-week phase II study, people on pimavanserin added to a main antipsychotic saw a significant improvement in the Negative Symptom Assessment-16 (NSA-16) total score (least squares mean -10.4 vs -8.5, P=0.043, effect size 0.21), reported Dragana Bugarski-Kirola, MD, of Acadia Pharmaceuticals in Princeton, New Jersey, at the virtual Psych Congress 2020 meeting. By the end of the trial, those receiving the final dose of 34 mg of pimavanserin on top of their antipsychotic saw significant improvement in negative symptoms (least squares mean -11.6 vs -8.5 with placebo, unadjusted P=0.0065, effect size 0.34). However by week 26, difference in the Personal and Social Performance scale score was not significant between the two groups.” Med Page today
7-22-2020- “The U.S. Food and Drug Administration (FDA) will review Acadia Pharmaceutical’s application asking that Nuplazid (pimavanserin) also be approved to treat hallucinations and delusions associated with various forms of dementia-related psychosis, the company announced. The supplemental new drug application (sNDA) was granted standard review status, and the FDA’s decision is expected by April 3, 2021. The regulatory agency found no issues with the application, and is not planning to request an advisory committee‘s independent advice and recommendations. Nuplazid targets a group of receptors, called serotonin 5-HT2A receptors, known to play an important role in psychosis, schizophrenia, depression, and other neuropsychiatric disorders. The therapy is a selective serotonin inverse agonist (SSIA), meaning it binds to these receptors. But instead of activating them, it blocks their activity. Nuplazid was approved under FDA’s breakthrough therapy designation to treat hallucinations and delusions associated with psychosis in people with Parkinson’s disease. This July 2018 approval was based on evidence showing Nuplazid’s use lessened symptoms of Parkinson’s-related psychosis, while minimizing the debilitating side effects that many antipsychotics cause.” Parkinsons News today
6-2-2020- “A federal judge has cleared the way for Acadia Pharmaceuticals Inc to face a proposed shareholder class action alleging it failed to disclose its Parkinson’s disease psychosis drug Nuplazid’s high death rate. U.S. District Judge Anthony Battaglia in San Diego on Monday rejected Acadia’s bid to dismiss the case on the grounds that information about the drug’s mortality rate had been public and that it had no obligation to accuse itself of wrongdoing.” Reuters
2-2-18- “IT IS THEREFORE ORDERED that pursuant to 28 U.S.C. § 1407, the actions listed on Schedule A and pending outside the Eastern District of Kentucky are transferred to the Eastern District of Kentucky and, with the consent of that court, assigned to the Honorable Karen K. Caldwell for coordinated or consolidated pretrial proceedings with the actions pending in that district and listed on Schedule A.” Transfer order
How Nuplazid Works
Nuplazid is intended to work primarily on the serotonin receptor. Serotonin is a neurotransmitter produced by the body that regulates mood. It is important to have serotonin levels carefully balanced. There are medications that can help the body produce serotonin, but too much of this substance is also a bad thing.
The nerve cells in the body try to absorb the serotonin as it is produced. This keeps it from reaching the brain, and the deficiency can cause mental illnesses such as depression. Specifically, Nuplazid is an aselective serotonin inverse agonist. In plain English, this means that the medication will bind itself to the serotonin and cause it to product the opposite reaction than it ordinarily would have had without the medication. While serotonin usually produces energy, when it is influenced by an inverse agonist, it will decrease the activity of the serotonin.
Nuplazid is intended to reduce the impact of serotonin
With regard to mental illness, Nuplazid is intended to reduce the impact of serotonin. It was the first drug that is approved to treat hallucinations that are a result of Parkinson’s disease. As the disease attacks the neurological system, approximately half of the patients with Parkinson’s experience some sort of psychosis. Nuplazid is intended to bind to the receptors without depressing dopamine, which is needed to treat Parkinson’s.
Nuplazid was approved by the FDA in 2016. Nuplazid had been granted breakthrough therapy designation, which allowed the FDA to expedite its review. The FDA study lasted only six weeks and included under 200 patients. In other words, the approval was based on only one single limited study. There were numerous prior tests that did not show a noticeable benefit of the drug. The approval vote was not unanimous as there were two dissenting votes. This was due to a concern of a higher incidence of death among those taking the drug. The drug did contain a general warning in the label that it could cause death, but no specific warning as to the type of death.
The drug was an immediate success financially. In the first full year after approval, sales of Nuplazid reached approximately $125 million. If the drug is approved to treat other mental illnesses, sales of Nuplazid could skyrocket. Nuplazid may also be used in the future to treat other mental illnesses such as major depression and schizophrenia. According to Acadia Pharmaceuticals, the drug is currently in Phase III trials for uses beyond treating symptoms associated with Parkinson’s disease. The company has claimed positive test results for these potential uses of the drug.
Side Effects of Nuplazid
The most common Nuplazid side effects are swelling of the ankles and feet, nausea and a confused or abnormal state of mind. Two years after the drug was approved, there have been reports of a higher death rate in patients taking the drug. CNN broker the news in an April 2018 report.
In addition to deaths, there have also been adverse events reported such as falls, life-threatening events and nausea. FDA data shows that there have been 700 deaths reported where the patient was taking Nuplazid. While it is difficult to state with certainty that Nuplazid was the cause of death for all of these patients, the number certainly represents a higher than usual rate of deaths when people are taking a specific medication. In addition, there were other reports of Nuplazid side effects such as patients’ hallucinations becoming worse after taking Nuplazid.
Troubling patterns in how the drug was prescribed
The physician who led the FDA’s review was quoted in the article as expressing concern about whether Nuplazid’s benefits outweighed the risks in light of the higher potential for death. Still, the FDA undertook a review of post-marketing reports and reaffirmed its belief that Nuplazid does not cause patient deaths. In any event, despite the broad generality of the warning on the label, the FDA maintains that any increase in deaths from patients taking Nuplazid is consistent with the warning of an increased risk of death. The FDA did find that there were troubling patterns in how the drug was prescribed, including prescribing Nuplazid in conjunction with other antipsychotics or heart medications.
Possible Product Liability Claims Against Acadia Pharmaceuticals
Notwithstanding the FDA’s determination, there is still the prospect of a slew of product liability lawsuits against Acadia Pharmaceuticals for deaths of patients that were taking Nuplazid. Plaintiffs’ attorneys are still conducting their own investigation in order to determine whether possible claims against Acadia are viable. The possible cases are still in their investigatory phases so it is too soon to tell the form that any possible lawsuits would take. Even if the generic warning of an increased risk of death is sufficient to have warned patients of the side effects, there are still numerous other product liability claims that Acadia could possibly face.
If a loved one has taken Nuplazid to treat symptoms of Parkinson’s disease and has experienced a severe adverse event, it is imperative that you contact a Nuplazid lawsuit lawyer as soon as possible to discuss your case. The Nuplazid lawsuit lawyer can inform you of your legal options and the process for recovery. Although the FDA issued its report claiming that Nuplazid was not to blame for deaths, that is not conclusive in terms of Acadia’s possible liability, and there is still the possibility of a legal recovery in the case.
Symptoms of psychosis
Some of those that suffer from Parkinson’s disease ultimately develop symptoms of psychosis as their central nervous system deteriorates. Nuplazid is a medication that has been approved by the FDA to treat this psychosis. Nuplazid works by acting on the serotonin receptor to reduce instances of hallucination and the psychosis. However, there have been reports that many deaths have been linked to taking the medication in just two years since the medication was approved by the FDA. As a result, attorneys are now investigating these reports, and there is a possibility that the manufacturer of this drug may be facing Nuplazid lawsuits in the future. If a loved one has taken this medication and either died or experienced severe side effects, you should immediately contact a Nuplazid lawsuit lawyer or law firm.
Parkinson’s-Related Psychosis
Nearly half of patients who have Parkinson’s disease will experience some type of psychosis at one point or another during their struggle with the disease. For many patients, this means that they have delusions or hallucinations. This could either occur as a side effect of dopamine therapy or as a natural progression of the disease. Many patients suffer from the psychosis without reporting it to their physician.
What is Nuplazid?
Nuplazid was approved by the FDA as a breakthrough medication. There is a special process for medications that are considered to be breakthroughs. Normally, extensive trials are required as part of the approval process, but breakthrough medications require less testing due to the benefits that result from the drug. Here, there was only six weeks of testing required on approximately 200 patients. This type of designation is relatively recent, having been approved as a process by Congress in 2012.
Nuplazid Side Effects
- swelling in the legs or arms,
- nausea,
- confusion,
- hallucination,
- constipation,
- changes to customary walking,
- death by heart attack
Nuplazid is manufactured by Acadia Pharmaceuticals. The drug was grated breakthrough status by the FDA in 2014 and was approved by the FDA for the treatment of Parkinson’s disease psychosis in 2016. Sales exceeded $100 million in the first full year that the drug was available. The drug is taken orally by tablet and patient’s must take two doses over the course of each day. Recently, the FDA approved one larger tablet to replace the twice-daily usage of the drug.
How Nuplazid Works
This medication works by blocking certain serotonin receptors. These receptors control various functions of the brain such as aggression, cognition and mood. The medication functions as an inverse agonist. This means that it is intended to target the receptor and produce a reaction opposite to the one that would ordinarily be produced by the receptor. In other words, Nuplazid changes the actions of the chemicals that are already in the brain. This process is independent of the efforts to stimulate dopamine that are the hallmark of the standard Parkinson’s treatment.
Side Effects of Nuplazid
The common side effects of Nuplazid are rapid heartbeat, shortness of breath and sudden dizziness. However, more sever side effects may result in those who have taken the drug. In April 2018, CNN reported on a large number of deaths among those who have taken the medication. CNN further reported that the physician who led the FDA review of the drug was concerned that a number of the patients in the trial experienced serious outcomes when taking the drug. Specifically, patients taking Nuplazid died at twice the rate of patients who were taking the placebo. There was some dissent during the FDA’s review of the medication, which ultimately resulted in the decision to fast-track approval of the drug. Two members of the panel voted against approval of the drug. There were three prior studies before the FDA approval that did not show that the medication was effective.
Multitude of deaths allegedly connected with the drug
Not only has there been a multitude of deaths connected with the drug, but many who have been prescribed the medication report that they are still experiencing hallucinations. The FDA has a mechanism for tracking adverse events associated with each drug, and there are scores of reports that have been filed in the two plus years that Nuplazid has been on the market. The reports have borne out the concern that the FDA panel had about the safety and efficacy of the drug.
FDA: black box label should not be updated
In the wake of the CNN article, the FDA conducted an investigation of Nuplazid. The FDA reviewed all of the adverse events, but concluded that Nuplazid’s safety profile should remain unchanged. While the FDA did not dispute the fact that there may have been a higher rate of death among those taking the drug, it rationalized that those with Parkinson’s have a higher rate of fatalities in general. Accordingly, it found that the black box label should not be updated since it accurately reflects the risks. The FDA continues to believe that the benefits outweighed the risks without disputing the fact that there may have been a higher rate of fatality in those taking the drug.
Inquiry from the federal government
Recently, CNN also reported that the maker of this troubled drug received an inquiry from the federal government pursuant to the False Claims Act. The nature of this inquiry has not yet been reported, but it became known through Acadia Pharmaceuticals’ SEC filings. The False Claims Act is usually the basis for government action when there is some sort of healthcare fraud that has resulted in a government overpayment of a fraudulent invoice sent to the government. This investigation, however, may touch upon the prescription practices as opposed to the side effects.
Nuplazid Parkinsons’ lawsuit
However, simply because the FDA did not order that Nuplazid be pulled from the market does not mean that any death that may have resulted from Nuplazid is not legally actionable. To the contrary, there are investigations underway about whether Nuplazid has caused patients’ death that may lead to the filing of lawsuits against Acadia Pharmaceuticals. If your loved one was prescribed Nuplazid and died, or you suffered through Nuplazid side effects you should seek out a Nuplazid lawsuit lawyer to discuss the possibility of filing a legal claim against the manufacturer of the drug. You should not delay because this will likely be a lengthy process since the first cases have not yet been filed.
Sources:
https://www.cnn.com/2019/03/08/health/nuplazid-justice-department-invs/index.html
https://www.cnn.com/2018/04/09/health/parkinsons-drug-nuplazid-invs/index.html
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm498442.htm
https://www.cnn.com/2018/04/09/health/parkinsons-drug-nuplazid-invs/index.html
