The Food and Drug Administration (FDA) recently completed an extensive review of all postmarking reports of serious adverse events (SAEs) and deaths linked to the use of Nuplazid (pimavanserin). Based on analysis of available data, the FDA did not identify any novel or surprising safety findings, or evidence that is inconsistent with the established safety profile currently listed in the drug label. The FDA’s conclusion remains unchanged, that the drug's benefits outweigh risks for patients with hallucinations and delusions attributed to Parkinson’s disease psychosis. The FDA conducted a comprehensive analysis of information submitted to the FDA Adverse Event Reporting System (FAERS), drug utilization data, safety data from the Nuplazid new drug application, the sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s analysis of fatal adverse event reports with Nuplazid, and published medical literature. While Nuplazid and other antipsychotics have a Boxed Warning suggesting increased risk of death in elderly patients with dementia-related psychosis associated with the use of these drugs, the FDA concluded that patients with Parkinson’s disease psychosis have a higher mortality rate due to their older age, advanced Parkinson’s disease, and other medical conditions. In the FAERS reports that included cause of death, there was no evident pattern to suggest a drug effect. Patients taking Nuplazid for Parkinson’s disease psychosis are encouraged to continue use, as prescribed by their health care provider. The FDA continues to monitor Nuplazid-associated adverse events and will update the public as necessary.
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