The US Food & Drug Administration’s (FDA) approval of Nuplazid (pimavanserin) for patients with Parkinson disease psychosis may have been rushed and released on little evidence, resulting in severe adverse events, according to news reports.

The drug, labeled as a “breakthrough therapy” for treating patients with Parkinson disease psychosis, was approved by the FDA in April of 2016 and available by June 2016. The evidence supporting the success of the drug was based on a 6-week clinical trial with a cohort of about 200 individuals. The FDA Advisory Committee approved the drug 12 to 2.

Some committee members stated that they would have rejected the approval of the drug if an effective alternative was available to patients. Others urged the consideration of a larger cohort for the study to solidify results.

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“Shortly after the drug’s release, patients’ family members, doctors, and other healthcare professionals started reporting ‘adverse events‘ possibly linked to the medication – including deaths, life-threatening incidents, falls, insomnia, nausea, and fatigue. In more than 1000 reports, patients continued to experience hallucinations while on Nuplazid,” according to a CNN report.

Of the 2236 adverse events linked to pimavanserin (reported to the FDA from June 2016 to March 2017), 244 deaths were reported (10.9%), 487 cases of hallucinations (21.8%), and 258 cases of confusional states (11.5%), according to a study published in QuarterWatch, an independent publication from the Institute for Safe Medication Practices; 333 deemed the drug ineffective (14.95%).

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“In that study, both hallucinations and confusional state also occurred more frequently as an adverse event in treated patients compared with those getting a placebo,” according to the QuarterWatch report.

“Since the institute released its analysis, FDA data show that the number of reported deaths has risen to more than 700,” according to the CNN report. “As of last June, Nuplazid was the only medication listed as ‘suspect’ in at least 500 of the death reports.”

“Parkinson’s disease psychosis [PDP] is more typically seen in elderly patients with numerous medical comorbidities, and with an overall high risk of morbidity and mortality,” according to a statement from Acadia Pharmaceuticals. “Since launch, Nuplazid overall mortality rate is 12.4 per 100 patient years. It’s important to note that this is lower than overall mortality rate for PDP patients in the Medicare Claims Database (2012-2015) of 28.2 per 100 patient years.”


  1. Ellis B, Hicken M. FDA worried drug was risky; now reports of deaths spark concern. CNN. April 9, 2018. Accessed April 10, 2018.
  2. Institute for Safe Medication Practices. Safety signals for two novel drugs: Hallucinations and pimavanserin (NUPLAZID), a new kind of drug for psychosis Hypotension with sacubitril-valsartan (ENTRESTO) for heart failure. Effective November 2017. Accessed April 10, 2018.
  3. Acadia response to CNN observations [news release]. San Diego, CA: Acadia Pharmaceuticals; April 9, 2018. Accessed April 10, 2018.