FDA Issues Statement Addressing Safety Concerns Associated With Nuplazid

Due to the number of reports of death and SAEs, the FDA decided to conduct a comprehensive analysis
Due to the number of reports of death and SAEs, the FDA decided to conduct a comprehensive analysis

A Food and Drug Administration (FDA) analysis of all Nuplazid (pimavanserin; Acadia) postmarketing reports related to serious adverse events (SAEs) and deaths, found no new or unexpected safety risks with its use. Based on the data, the FDA has concluded that the drug's benefit continues to outweigh its risks for patients with hallucinations and delusions associated with Parkinson's disease psychosis.

Nuplazid is an atypical antipsychotic that carries a Boxed Warning describing the increased risk of mortality in elderly patients with dementia-related psychosis associated with the use of these agents. Concerns over Nuplazid were initially voiced in a CNN article in early April 2018 which reported that the drug had been associated with over 700 deaths since its launch in March 2017. The number was calculated using the FDA's Adverse Events Reporting System (FAERS) Public Dashboard.

Due to the number of reports of death and SAEs, the FDA decided to conduct a comprehensive analysis of all existing data. In addition to published medical literature, they analyzed data submitted to FAERS, drug utilization data, safety data from the Nuplazid New Drug Application, the sponsor's Pediatric Adverse Drug Experience Reports, and the sponsor's analysis of fatal adverse event reports.

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When assessing the reports of death, the FDA factored in that patients with Parkinson's disease psychosis would have a higher mortality rate due to their older age, advanced disease, and other comorbidities. The Agency also determined that cases of death would more likely be reported to the manufacturer as Nuplazid is mainly distributed through a patient support program and a specialty pharmacy network. For the FAERS reports that included a cause of death, there was no clear pattern to suggest it was treatment-related.

"Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson's disease psychosis," the FDA stated in a press release.

While no new or unexpected safety concerns were identified, the FDA noted some potentially concerning prescribing patterns. These include concomitant use with other antipsychotics or QT-prolonging drugs. The Nuplazid labeling already contains a warning about the risk of QT prolongation and serious arrhythmia.

As with any medication, healthcare professionals should be aware of the safety risks listed in the prescribing information. With regard to Nuplazid, the FDA will continue to monitor adverse event reports and update the public as necessary.

Clinicians and patients can report suspected adverse events associated with Nuplazid to the FDA's MedWatch program.

Nuplazid is supplied as 10mg tablets and 34mg capsules in 30-count bottles.

For more information visit FDA.gov.