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Nuplazid is a medication that is used an anti-psychotic drug, treating symptoms associated with Parkinson’s disease. It also has the possibility to treat schizophrenia and major depressive disorder. It belongs to the atypical antipsychotic class of medications and has recently been approved by the FDA. However, numerous people who 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 the 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 lawyer immediately to discuss your case.

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 | Nuplazid lawsuit

The most common side effects of Nuplazid 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 patients’ hallucinations becoming worse after taking Nuplazid.

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.

Sources:

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm498442.htm

https://www.cnn.com/2018/04/09/health/parkinsons-drug-nuplazid-invs/index.html

https://fis.fda.gov/sense/app/777e9f4d-0cf8-448e-8068-f564c31baa25/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis