FDA Analysis Finds No New or Unexpected Safety Risks of Pimavanserin:Benefits Outweigh Risks
The Food and Drug Administration (FDA) announced that there are no new safety concerns for pimavanserin (Nuplazid; Acadia Pharma, San Diego, CA). Pimavanserin is approved for the treatment of psychotic symptoms—hallucinations and delusions—in patients with Parkinson's disease (PD) dementia. After extensive review of postmarket safety concerns, the FDA concluded that benefits of treatment outweigh the risks.
Pimavanserin and other antipsychotics have a boxed warning regarding an increased risk of death in elderly patients with dementia-related psychosis. Because concerns were raised about the number of adverse events and deaths in patients taking pimavanserin, the FDA initiated a review of all such reports. In addition to finding no new safety concerns, the FDA found the postmarket safety profile is consistent with the safety profile established at the time of the drug’s approval; these safety risks are detailed in the existing drug label. No changes to the indications or package inserts are needed or requested. No report regarding pimavanserin in the FDA adverse event reporting system (FAERS) that included a death suggested a drug-related cause of death, although many reports did not provide sufficient information to assess drug cause and effect fully.
In addition to FAERS reports, the FDA analyzed information from the new drug application for pimavanserin, the sponsor’s periodic adverse drug experience reports and analysis of the same, drug utilization data, and published medical literature.
The FDA considered that patients taking pimavanserin are older and have PD and other medical conditions. They also considered that pimavanserin is distributed primarily through specialty pharmacies and with a patient support program in effect for most prescriptions, increasing the likelihood that adverse events would be reported.
The FDA did note that concerning prescribing patterns may be occurring, including concomitant use of other antipsychotic drugs or drugs that can cause QT prolongation, a potential cause of arrythmia. The risk of QT prolongation and serious arrhythmia associated with pimavanserin is noted in the warnings and precautions section of the drug label. The FDA reminded health care providers to be aware of these risks. The FDA also included a reminder that no other antipsychotic is approved for the treatment of PD-related dementia.
Patients taking pimavanserin for PD dementia-related psychosis should continue to use it as prescribed. The FDA will continue to monitor reports of adverse events associated with pimavanserin and communicate any updates as needed.