Nuplazid Benefits Outweigh Risks for PD Patients, FDA Says

The Food and Drug Administration (FDA) earlier this month announced the agency had completed a review of postmarketing reports of deaths and serious adverse events reported with the use of Nuplazid (pimavanserin), which is approved for the treatment of Parkinson’s disease psychosis.

“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 agency wrote in a press release. “After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis.”

The review came after several reports of death and other serious adverse events associated with Nuplazid earlier this year. In conducting its review, the FDA factored in that patients with Parkinson’s disease psychosis generally are older, have more advanced Parkinson’s disease, and are more likely to have other medical problems—all of which contribute to mortality risk. In addition, the agency noted that many of the deaths entered in FDA Adverse Event Reporting System did not provide enough information to assess whether Nuplazid was a cause of the mortality.

While the FDA did not identify any new or unexpected safety risks, some potentially concerning prescribing patterns were observed, such as the concomitant use of Nuplazid with other antipsychotic drugs or drugs that can cause QT prolongation, a risk factor for arrhythmia.