Nuplazid (Pimavanserin)

DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.

Nuplazid (pimavanserin) is a prescription medication used to treat dementia-related psychosis. Made available in May 2016, Nuplazid is available for those who suffer from the delusions and hallucinations commonly associated with:

  • Alzheimer’s disease
  • Parkinson’s disease
  • Vascular dementia
  • Frontotemporal dementia
  • Dementia with Lewy bodies

In particular, Nuplazid is marketed to help those who suffer from Parkinson’s disease psychosis. Psychosis affects up to 50 percent of Americans suffering from Parkinson’s. Nuplazid was the first drug ever approved by the FDA to treat Parkinson’s disease psychosis.

Unfortunately, victims of Parkinson’s disease psychosis have suffered many severe side effects following the drug’s release. The FDA is now reinvestigating Nuplazid due to these effects, some of which have resulted in death.

Who Makes Nuplazid?

Acadia is a pharmaceutical company whose sole product is Nuplazid. Founded in 1997, Acadia has been working on Nuplazid ever since.

Although Acadia only has one product, the company has been doing fairly well. In 2017, they made $124.9 million in sales, up from just $17.3 million in 2016. For 2018, Acadia projects between $255 million and $270 million in Nuplazid sales. Nuplazid typically costs around $100 a day.

Is Nuplazid FDA-Approved?

Nuplazid was approved by the U.S. Food and Drug Administration (FDA) in April 2016 after receiving “Breakthrough Therapy Designation” from the FDA.

Breakthrough Therapy Designation allows companies to expedite the development and review of certain drugs. Typically, in order to receive this designation, the drug in question has to treat a serious condition. Preliminary clinical evidence also has to suggest that the drug may be a significant improvement to the kind of treatment (if any) that is already available.

In order to recommend approval, the drug’s advisory committee must find that the drug’s potential benefits outweigh its risks. Nuplazid was the first drug of its kind to get approval from the FDA. The committee recommended approval to the FDA based on a single six-week study of 200 patients. Three previous studies had not proven as effective, although they did demonstrate similar risks to the six-week study in question.

What Are the Side Effects of Nuplazid?


After the drug’s release, many patients experienced serious “adverse events,” including:

  • Falls
  • Insomnia
  • Nausea
  • Fatigue
  • Life-threatening incidents
  • Death

To make matters worse, more than 1,000 patients reported that they continued to experience the same hallucinations Nuplazid was supposed to stop.

In November 2017, the Institute for Safe Medication Practices released an analysis that showed that 244 deaths had been reported to the FDA between the drug’s launch and March 2017.

Adverse event reports to the FDA do not state unquestioningly that a person’s experience is directly caused by a specific drug. Some people who file these reports, often on behalf of the family member experiencing the adverse event, are adamant that the drug in question caused the adverse event. Others, however, simply report what happened and make note that the patient was taking the specific drug at the time of the event. It’s up to the FDA to use the reports to determine whether there is a potential problem with the drug in question.

As of April 2018, FDA data showed that the number of reported deaths has increased to more than 700.

Has Acadia Warned Patients of Potential Side Effects?

Like all antipsychotics, Nuplazid is required to carry a “black box” warning. As the most severe FDA warning, a black box warning means that “an adverse reaction to the drug may lead to death or serious injury.” However, there is concern that consumers do not fully understand the potential danger associated with Nuplazid.

What Should I Do If My Loved One Is Suffering Severe Side Effects from Nuplazid?

If you or a loved one is suffering an adverse event from taking Nuplazid, seek medical attention immediately. Do not stop taking an FDA-approved drug without first consulting your doctor. Hensley Legal Group does not recommend that you cease taking any FDA-approved drug without first consulting a licensed medical professional.

If you or your loved one has suffered an adverse side effect from Nuplazid, you may be eligible for compensation. An Indiana personal injury attorney can take a look at your case and help you determine what your options are. Call Hensley Legal Group today for a free conversation about your claim, or contact us online.

DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.