A Nuplazid lawsuit may be an option for people who have experienced serious complications associated with the drug, including hallucinations and death. Nuplazid is an antipsychotic drug used to treat hallucinations (auditory and visual), delusions and other symptoms of psychosis in patients with Parkinson’s disease. Only one clinical trial was conducted prior to the drug’s approval, and adverse event reports suggest that Nuplazid may be linked to more than double the risk of death and other serious complications. Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.
If you or a loved one have been adversely affected by a potentially dangerous drug, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Nuplazid Lawsuit Commercial?
You may have seen a Nuplazid lawsuit commercial on television and wondered whether you or a loved one have been affected by it and similar drugs and, if so, whether you are eligible to pursue a claim against the drug manufacturer or distributor. The purpose of this article is to provide you with additional information about lawsuits and other litigation involving dangerous drugs so that you have a better understanding of your options.
Parkinson’s Disease Psychosis
Parkinson’s disease is a disorder of the central nervous system that primarily affects a person’s movement. Symptoms of Parkinson’s disease most often include tremors, slowness of movement (known as bradykinesia), stiffness and loss of balance. According to
Individuals who have Parkinson’s disease may experience a non-motor symptom of the disease commonly referred to as Parkinson’s disease psychosis. According to the American Parkinson Disease Association (APDA), psychosis related to Parkinson’s disease is complex and there is not currently a clear understanding of its exact cause.
The most prominent symptoms of Parkinson’s disease psychosis are hallucinations and delusions. Diagnosis and treatment of can be difficult because the condition is considered a neuropsychiatric condition potentially caused by a disease of the nervous system.
What is Nuplazid?
Nuplazid is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid was approved by the U.S. Food and Drug Administration (FDA) in April 2016 and is manufactured by Acadia Pharmaceuticals Inc., a biopharmaceutical company headquartered in San Diego, California.
Nuplazid (also known as pimavanserin) is the first and only medication approved by the FDA for the treatment of hallucinations and delusions related to Parkinson’s disease psychosis. Although the exact mechanism of action of the drug is unknown, it is thought that a combination of substances that initiate and interfere with physiological actions at serotonin receptors.
FDA Approval and Clinical Study
Before the FDA approves a drug for sale to the public, pharmaceutical companies in the United States must first demonstrate that the drug is safe for consumer use. In the United States, the FDA’s Center for Drug Evaluation and Research (CDER) is responsible for evaluating evidence provided by drug companies to ensure that a drug’s benefits outweigh any known risks.
To establish the efficacy of Nuplazid, a six-week clinical trial was conducted. Men and women 40 years of age and older were included in the outpatient trial; each participant had been diagnosed with Parkinson’s disease and demonstrated severe and frequent psychotic symptoms (such as hallucinations and/or delusions).
The Institute for Safe Medication Practices (ISMP), a nonprofit organization devoted to the prevention of medical errors, investigated four groups of reported adverse events for Nuplazid after the drug was approved by the FDA. Analysis by the group showed that, in some cases, adverse events of hallucinations could have indicated “that the drug was making some psychosis worse.”
According to a report by the ISMP in November 2017, the FDA “relied on a single clinical trial indicating a minimal treatment effect, used a measurement scale for symptoms that had not been validated, and succeeded only after three previous trials had failed to demonstrate a benefit.” Likewise, the report indicated that the FDA’s medical reviewer recommended against approval of the drug and was overruled.
Nuplazid Side Effects
According to the FDA, clinical trials noted that the most common side effects associated with Nuplazid include swelling, usually of the ankles, legs, and feet as a result of the accumulation of excessive fluid in the tissue; nausea; and abnormal or confused state of mind.
Nuplazid Death Risk
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
According to Nuplazid’s prescription information sheet, analyses of 17 dementia-related psychosis placebo-controlled trials (modal duration of 10 weeks and largely in patients taking atypical antipsychotic drugs) revealed a risk of death in the drug-treated patients of between 1.6- to 1.7-times that in placebo-treated patients.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Additionally, a report published by CNN.com in April 2018 notes that the physician who led the FDA’s medical review warned “that patients taking the drug during the company’s clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo.” Although the FDA and Acadia Pharmaceuticals Inc. maintain that the benefits of Nuplazid outweigh the risks and help fill a need, some physicians and medical researchers told CNN that “they worried that the drug had been approved too quickly, based on too little evidence that it was safe or effective.”
The FDA is reportedly continuing to monitor the adverse event reports, and in a follow-up report published by CNN in late April 2018, the agency has begun conducting a new evaluation of the drug.
Other Nuplazid Risks
Nuplazid prolongs the QT interval, a measure of the time between the start of the Q wave and the end of the T wave in the heart’s electrical cycle. Its use should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval.
This may include some antiarrhythmics (such as quinidine, procainamide, amiodarone), certain anti-psychotic medications (such as ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (such as gatifloxacin, moxifloxacin). Patients with a history of cardiac arrhythmias and other circumstances that may increase the risk of the occurrence of torsadas de pointes and/or sudden death should avoid using Nuplazid.
Lauren A. on May 16, 2016
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Has There Been a Nuplazid Recall?
Since the drug’s approval in 2016, the FDA has not notified the public of a Nuplazid recall. Drug recalls may be conducted by the drug manufacturer, by FDA request, or by FDA order.
Potential litigation could possibly claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Is There a Nuplazid Class Action Lawsuit?
At the time of publication, no Nuplazid class action lawsuit has been filed on behalf of patients who experienced serious complications associated with the drug. Likewise, Nuplazid lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the drug. Instead, if multiple lawsuits are filed against the drug makers alleging injuries and other damages caused by Nuplazid and similar drugs, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called a multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by pharmaceutical products.
Have There Been Any Nuplazid Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any Nuplazid lawsuit settlements at this time. Instead, it is expected that Nuplazid lawsuits will be consolidated in federal court through an MDL. Nuplazid lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
Nuplazid Lawsuit News
- April 2018 CNN report indicates that the U.S. Food and Drug Administration has begun conducting a new evaluation of Nuplazid after hundreds of deaths were voluntarily reported by caregivers, doctors and other medical professionals.
- April 2018CNN publishes report in which a physician warned of serious risks associated with Nuplazid during the manufacturer’s clinical trials, including death, at more than double the rate of those patients taking the placebo.
- November 2017Report by the Institute for Safe Medical Practices concluded that early adverse event data supports concerns about the approval of Nuplazid as well as the drug’s associations with hundreds of serious adverse events, including death.
- April 2016According to a press release issued by the U.S. Food and Drug Administration, the agency approved Nuplazid “to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.”
How a Nuplazid Lawsuit Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Nuplazid or other similar drugs may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.