FDA Analysis Finds No Unexpected Safety Risks Associated With Pimavanserin

The FDA did not identify any new or unexpected safety findings with pimavanserin (Nuplazid), nor findings that are inconsistent with the established safety profile currently described in the drug label, in an analysis of all available data. The review was conducted following postmarketing reports of deaths and serious adverse events with use of the drug, indicated for treating patients with hallucinations and delusions of Parkinson disease psychosis. In announcing the investigation’s outcome, officials with the FDA said the agency’s conclusion remains that the medication’s benefits outweigh its risks.

Nuplazid and other antipsychotics have a Boxed Warning regarding the increased risk of death in elderly patients with dementia-related psychosis associated with the use of these drugs. The FDA’s review took into account numbers of reports of death and other serious adverse events, as well as 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.

In assessing reports of deaths, FDA investigators considered that patients with Parkinson disease psychosis, for whom pimavanserin is indicated, have a higher mortality rate due to their older age, advanced Parkinson disease, and other medical conditions. Moreover, pimavanserin is primarily distributed through a patient support program and a specialty pharmacy network, which increases the likelihood that deaths will be reported to the manufacturer. In FAERS reports that included a cause of death, there was no evident pattern to suggest a drug effect. Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson disease psychosis.

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