Nuplazid Safety Risks May Lead FDA To Re-Review New Medication, Gottlieb Tells Senate

During questioning last week by a Congressional committee, the head of the FDA announced that the agency is now taking another look at the potential side effects of Nuplazid, re-examining the safety and effectiveness of the controversial new drug designed to treat Parkinson’s disease hallucinations, which has been linked hundreds of patient deaths. 

FDA Commissioner Scott Gottlieb announced the safety review during testimony before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies.

In Gottlieb’s written testimony submitted to the subcommittee, there is no mention of Nuplazid or a renewed safety review, but a CNN report indicates FDA sources confirmed that the new evaluation began several weeks ago.

Nuplazid (pimavanserin) is an atypical antipsychotic, which is used to reduce hallucinations experienced by Parkinson’s disease patients. The drug was just introduced by Acadia Pharmaceuticals in April 2016, after it was approved by the FDA through a fast track “Breakthrough Therapy” process. However, an alarming number of Nuplazid problems have been reported by individuals nationwide.

Since 2016, the FDA’s Adverse Events Reporting System (FAERS) has already received 5,735 incidents involving problems with Nuplazid, with most reports filed over the past year.

Nuplazid problems have also been linked to at least 712 death reports. While the reports do not necessarily mean that Nuplazid was the cause of the deaths, at least 500 of those fatality reports listed Nuplazid as the only suspect medication the patient was taking.

Before the FDA approved the drug, the agency’s scientific advisors warned that there appeared to be a disturbing number of deaths linked to the drug, and some of its own reviewers raised questions about its safety and whether there may need to be a Nuplazid recall.

It is unclear how long the FDA’s safety review will take, or if a Nuplazid recall is being considered.

Since the drug was approved the for the treatment of hallucinations and delusions linked to Parkinson’s disease psychosis (PDP), Nuplazid generated about $125 million in sales last year for Acadia Pharmaceuticals.

The Institute for Safe Medication Practices (ISMP) issued a warning about Nuplazid safety signals in its November 2017 QuarterWatch report, indicating that the FDA had received 2,236 adverse event reports over the course of its first year on the market, including 244 deaths and signs that the drug may actually worsen hallucinations in some cases.

Potential side effects of Nuplazid reported to federal health regulators also include falls, insomnia, nausea, and fatigue.