FDA analysis concludes no unexpected safety risk associated with pimavanserin

In an analysis of all available data, the FDA found no new or unexpected effects on the safety of pimavanserin (Nuplazid), nor any findings inconsistent with the currently established safety profile described on the drug's label. The review was conducted as a result of post-marketing reports of deaths and serious adverse events related to the use of the drug, indicated for the treatment of patients with hallucinations and delusions of psychosis of the Parkinson disease. In announcing the outcome of the investigation, FDA officials said the agency had always come to the conclusion that the benefits of the drug outweighed its risks.

Nuplazid and other antipsychotics have a boxed warning regarding the increased risk of death in elderly patients with dementia-related psychosis associated with the use of these drugs. The FDA review took into account the number of reports of deaths and other serious adverse events, as well as information submitted to the adverse event notification system (FAERS), data on the use of medications , Drug Experience Reports, the sponsor's analysis of reports of fatal adverse event with Nuplazid and the published medical literature.

In evaluating death reports, FDA investigators have estimated that patients with Parkinson's psychosis, for whom pimavanserin is indicated, have higher mortality rates because of their advanced age. Pimavanserin is primarily distributed as part of a patient support program and a network of specialty pharmacies, which increases the likelihood of deaths being reported to the manufacturer. In the FAERS reports that included a cause of death, there was no obvious tendency to suggest a drug effect. Overall, the postmarketing data was consistent with the safety data obtained from pre-market controlled clinical trials of Nuplazid for Parkinson's disease psychosis.

Although the FDA has not identified any new or unexpected safety risks, some prescribing patterns of potential concern have been observed, such as the concomitant use of other antipsychotic drugs or possibly leading to prolongation of the QT interval. The risk of prolonging the QT interval and serious arrhythmia associated with Nuplazid is noted in the Warnings and Precautions section of the drug's label, which warns of the risks increased associated with the use of the drug in combination with other drugs known to lengthen the QT interval. Based on this observation, FDA officials remind health care providers to be aware of the risks described in the prescribing information. The FDA also reminds healthcare providers that no other antipsychotic medications are approved for the treatment of Parkinson's disease psychosis.

Patients taking pimavanserin to treat psychosis due to Parkinson's disease should continue to use it as prescribed by their health care provider, as the FDA continues to monitor reports of adverse events associated with Parkinson's disease. drug. The agency also encourages health care providers and patients to report suspected adverse reactions involving Nuplazid and other drugs to the FDA's MedWatch program.

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Click to read A closer look at Nuplazid for the psychosis of Parkinson's disease.

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Reference

The FDA's analysis does not reveal any new or unexpected safety risks associated with Nuplazid (pimavanserin), a drug to treat hallucinations and delusions of Parkinson's disease. [news release]. Silver Spring, MD; September 20, 2018: FDA website. http://www.pharmacytimes.com/link/220. Accessed September 20, 2018.