FDA Aware of Nuplazid Deaths, Other Adverse Events, But Won’t Modify Label Warnings

Published on April 18, 2018 by Sandy Liebhard

The U.S. Food & Drug Administration is continuing to monitor side effects and deaths among Parkinson’s disease patients treated with Nuplazid.

For now, however, the agency sees no reason to alter the safety information currently included on the medication’s label.

“We are aware of adverse events associated with Nuplazid and continue to review the drug’s safety profile,” a press officer in the FDA’s Office of External Affairs recently told Parkinson’s News Today in response to a CNN investigation that raised serious concerns about Nuplazid deaths and side effects.

The official was responding to a recent CNN report that detailed thousands of adverse events – including more than 200 deaths – reported to the agency in relation to Nuplazid since its approval in 2016.

Nuplazid FDA Approval

Nuplazid (pimavanserin) is marketed by California-based Acadia Pharmaceuticals and was the first medication ever approved by the FDA to treat hallucinations and delusions sometimes experienced by Parkinson’s disease patients in the course of their disease.

Because it was designated a “Breakthrough Therapy” by the agency, Nuplazid was approved on the basis of a single clinical trial that lasted just six weeks and involved only around 200 patients. During the study, patients treated with Nuplazid had double the rate of deaths and other serious adverse events compared to those who received a placebo.

Three earlier studies had not shown Nuplazid to be effective, though they did find similar risks.

According to CNN, some members of the FDA expert panel charged with reviewing Nuplazid prior to its approval did express concerns about its safety profile. Still, the panel recommended that Nuplazid be approved by a vote of 12-2.

Soon after it came to market, patients and doctors began reporting adverse events possibly related to Nuplazid, including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue. More than 1,000 of those reports indicated that Nuplazid patients had continued to continued to experience hallucinations and delusions.

ISMP Analysis Uncovers 2,200+ Nuplazid Adverse Event Reports

In November 2017,  the Institute for Safe Medication Practices (ISMP) warned that the FDA’s adverse event database had logged 2,236 Nuplazid reports between its 2016 approval and March 2017. The Nuplazid reports included 244 deaths.

“The overall message in these adverse event reports is that hundreds of health professionals are trying this new drug with their patients and reporting that either it is not providing the expected benefit or making some psychosis worse,” the ISMP concluded. “The large number of deaths also remains a concern in a setting where increased mortality was at least suspected if not proven in the clinical trials.

While adverse event reports do not constitute proof that a drug is dangerous, experts consulted by CNN said that the reports were proof that more needed to be done to assess the safety and effectiveness of Nuplazid, with some worrying that the drug had been rushed to market.

“This is almost unheard of, to have this many deaths reported,” Diana Zuckerman, founder and president of the nonprofit thinktank the National Center for Health Research, told CNN. “You just don’t see this with most new drugs — you don’t see all these reports — so you have to take it seriously.”