FDA Analysis Concludes No Unexpected Safety Risks Associated With Pimavanserin

The FDA did not identify any new or unexpected safety findings with pimavanserin (Nuplazid), nor findings that are inconsistent with the established safety profile currently described in the drug label, in an analysis of all available data. The review was conducted following postmarketing reports of deaths and serious adverse events with use of the drug, indicated for treating patients with hallucinations and delusions of Parkinson disease psychosis. In announcing the investigation’s outcome, officials with the FDA said the agency’s conclusion remains that the medication’s benefits outweigh 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’s review took into account numbers of reports of death and other serious adverse events, as well as information submitted to the FDA Adverse Event Reporting System (FAERS), drug utilization data, safety data from the Nuplazid new drug application, the sponsor’s Periodic Adverse Drug Experience Reports, the sponsor’s analysis of fatal adverse event reports with Nuplazid, and published medical literature.

In assessing reports of deaths, FDA investigators considered that patients with Parkinson disease psychosis, for whom pimavanserin is indicated, have a higher mortality rate due to their older age, advanced Parkinson disease, and other medical conditions. Moreover, pimavanserin is primarily distributed through a patient support program and a specialty pharmacy network, which increases the likelihood that deaths will be reported to the manufacturer. In FAERS reports that included a cause of death, there was no evident pattern to suggest a drug effect. Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson disease psychosis.

Although the FDA did not identify any new or unexpected safety risks, some potentially concerning prescribing patterns were observed, such as the concomitant use of other antipsychotic drugs or drugs that can cause QT prolongation, a potential cause of heart rhythm disorder. The risk of QT prolongation and serious arrhythmia associated with Nuplazid is noted in the Warnings and Precautions section of the drug label, which warns of the increased risks associated with using the drug product together with other drugs known to cause QT interval prolongation. 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 heath care providers that none of the other antipsychotic medications are approved for the treatment of Parkinsons disease psychosis.

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

Click to read A Closer Look at Nuplazid for Parkinson's Disease Psychosis.

Reference

FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson’s disease psychosis [news release]. Silver Spring, MD; September 20, 2018: FDA website. http://www.pharmacytimes.com/link/220. Accessed September 20, 2018.