Approximately one million people suffer from Parkinson’s disease in the United States and 40 percent of them will experience a psychosis episode. Nuplazid is the first and only medication specifically designed to help treat psychosis in Parkinson’s. However, the drug has come under scrutiny due to safety concerns for patients on using Nuplazid. Here, the pharmaceutical liability attorneys at The Law Offices of Peter G. Angelos discuss the recent developments regarding Nuplazid.
An investigative report conducted by CNN, has highlighted the potential health dangers associated with the use of Nuplazid, an antipsychotic drug used by patients who suffer from hallucinations brought on by Parkinson’s disease.
What is Nuplazid?
Nuplazid, manufactured and distributed by Acadia Pharmaceuticals, is an atypical antipsychotic drug designed to treat psychosis–a mental disorder characterized by a disconnection from reality– specifically that which is brought on by Parkinson’s disease. The drug is meant to treat or limit hallucinations and delusional episodes.
Nuplazid In the Market
In June 2016, Nuplazid was officially introduced to the market following an expedited review by the FDA. The expedited review came as a result of a clinical trial in which Nuplazid had shown significant promise in treating psychosis related to Parkinson’s. The FDA designated Nuplazid as a “breakthrough therapy”—indicating that the drug demonstrated “substantial improvement” in patients with serious or life-threatening diseases compared to any other treatment available on the market.
To recommend approval, the FDA’s advisory committee was required to evaluate whether the drug’s potential benefits outweighed the risks for intended patients. The committee voted 12-2 in favor of the drug’s safety and recommended that the FDA approve Nuplazid for the treatment of Parkinson’s-related psychosis based on the six-week study of 200 patients.
What is the Issue?
Shorty after the drug’s release, patients’ family members, doctors and other healthcare providers reported “adverse events” possibly linked to the medication—including life threatening incidents, insomnia, falls, nausea, fatigue and even death. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.
An analysis released by the Institute for Safe Medication Practices, a non-profit healthcare organization, warned that 244 deaths, possibly linked to Nuplazid, had been reported to the FDA between the drug’s launch and March 2017. Since the release of the analysis, FDA data shows that the number of reported deaths has risen to more than 700.
An outspoken critic of Nuplazid and leader of the FDA’s medical review of the drug, Dr. Paul Andreason allegedly had reservations about the antipsychotic drug. He claimed that patients taking the drug during the clinical trial experienced “serious outcomes”, including death, at more than double the rate of those taking the placebo. According to reports, Dr. Andreason remained unconvinced by the limited testing and results from the trial.
The CNN report also suggests that committee members held reservations about Nuplazid as well, with one member allegedly stating, “I guess I’m hoping that the risks are going to be small, and I think the benefits for some of these people who are very sick and whose families are affected by this, I think they’re probably willing to take that risk.” Another member added that she would never have voted for the approval of the drug had a safer alternative been readily available to the public.
A third member of the committee reportedly made a “plea” to the FDA to refrain from voting on the approval of the drug and to consider implementing a large-scale study to ensure that the benefits outweigh the risks before releasing the drug for mass use.
FDA’s Current Stance
Acadia Pharmaceuticals and the FDA maintain that the medication’s potential benefits continue to outweigh the risks, and that Nuplazid plays a vital role for those who suffer from psychosis brought on by Parkinson’s disease. Acadia has attributed the high number of deaths on the adverse reports sent to the FDA to the fact that Parkinson’s disease psychosis is more commonly seen in patients in the most advanced stages of the disease, meaning they are already at a high risk of death. Additionally, the company distributes Nuplazid through a network of specialty pharmacies that allows it more frequent contact with both patients and caregivers –meaning Acadia is more likely to receive reports of death, which it is then required to pass along to the FDA.
Have You Suffered After Using Nuplazid?
If you or a loved one has suffered an injury after using Nuplazid to treat psychosis related to Parkinson’s disease, it is important that you consult with your healthcare provider to see if there are any necessary steps you may need to take to ensure your health and safety. It may also be important to consult with an experienced pharmaceutical liability attorney regarding your claim and your rights to compensation. For more information, or to schedule a free consultation, contact the pharmaceutical liability attorneys at The Law Offices of Peter G. Angelos.