Update on NUPLAZID — FDA finds no new or unexpected safety risks

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4 years 11 months

On September 20, 2018, the U.S. Food and Drug Administration (FDA) issued a review on the drug NUPLAZID (pimavanserin), a medication used to treat patients with hallucinations and delusions associated with Parkinson’s Disease psychosis.

According to the FDA website:

“Based on an analysis of all available data, FDA did not identify any new or unexpected safety findings with NUPLAZID, or findings that are inconsistent with the established safety profile currently described in the drug label. 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...

Patients taking NUPLAZID for Parkinson’s disease psychosis should continue to use it as prescribed by their health care provider. FDA continues to monitor reports of adverse events associated with NUPLAZID.”

NUPLAZID was approved by the FDA in 2016 and is manufactured by Acadia Pharmaceuticals. NUPLAZID is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson’s Disease psychosis.

For more information on this topic, please call our toll-free Helpline at 1-800-4PD-INFO (473-4636). 

For background about this issue, please read our previous statement related to Nuplazid.

For more information about Psychosis and Parkinson’s Disease:

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