FDA review supports Nuplazid’s safety


Pimavanserin (Nuplazid) remains an acceptable treatment for the hallucinations and delusions associated with Parkinson’s disease, according to a statement issued by the Food and Drug Administration after the agency conducted a postmarketing review of deaths and serious adverse events associated with the drug.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License

“Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings” associated with the drug, according to the Sept. 20 statement.

However, the FDA researchers identified prescribing patterns that might increase the risk of serious adverse events, such as the concomitant use of pimavanserin and other antipsychotic drugs or drugs that can cause QT prolongation. The QT prolongation risk is listed on the drug label, which also includes a Boxed Warning about increased mortality risk in elderly patients.

The FDA statement reminds clinicians to know the risks described in the label and to be aware that no other antipsychotics are currently approved for psychosis in Parkinson’s patients.

The review was prompted by the number of reports of serious adverse events and deaths associated with pimavanserin, based on data obtained from multiple sources including the FDA Adverse Event Reporting System (FAERS), drug utilization data, safety data from the new drug application, the sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s analysis of fatal adverse event reports, and data from published medical literature.

When conducting the review, the FDA considered several factors, including the fact that Parkinson’s disease patients have higher mortality in general because of older age, advanced disease, and other medical comorbidities. In addition, pimavanserin adverse events and deaths are more likely to be reported because the drug is distributed mainly through a patient-support program and specialty pharmacy. The FDA also found no pattern suggestive of a drug effect on causes of death in patients whose deaths were reported through FAERS.

“Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis,” according to the FDA statement.

Next Article: