Pimavanserin (Nuplazid™), the first atypical antipsychotic for Parkinson’s disease (PD) – related psychosis (eg, hallucinations and delusions), received FDA priority review and approval in 2016. Like other atypical antipsychotics, it carries a black box warning about increased risk of death when used in older adults with dementia-related psychosis.
Between the drug’s launch in June 2016 and March 2017, the FDA received 2,236 adverse event reports linked to pimavanserin, including 244 deaths. In addition, hallucinations (22%), lack of effectiveness (15%), and confusion (12%) were commonly reported. The number of deaths possibly linked to pimavanserin has risen to 741. Older adults with advanced PD, already suffering from numerous health conditions, have been affected the most.
Prescribing atypical antipsychotics for dementia increases the risk of death by 1-2%. The risk with pimavanserin is likely much greater. Due to the high death rate, other significant side effects and limited effectiveness, the use of pimavanserin for PD psychosis should be reevaluated, particularly its use among older adults with advanced PD.
• Kunzmann K. Food and Drug Administration 2018;published online April 2018.