The Food and Drug Administration announced Thursday it had not identified any “new or unexpected safety findings” related to a drug used to treat psychosis in Parkinson’s patients, though it did find potentially troubling prescribing practices.
Nuplazid, which hit the market in 2016, is the only medication approved to treat hallucinations and delusions associated with a debilitating condition known as Parkinson’s disease psychosis. It has been cited as a “suspect” medication in hundreds of deaths voluntarily reported to the agency, as highlighted in a CNN report earlier this year.
Medical experts told CNN at the time that the high number of so-called “adverse event reports” deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.
Nuplazid’s initial review was expedited by the FDA because it had been designated a “breakthrough therapy,” meaning it demonstrated “substantial improvement” in patients with serious or life-threatening diseases compared to treatments already on the market.
After CNN published its investigation on Nuplazid, reporters were contacted by family members who said they believed the drug contributed to their loved one’s decline or death. Others said Nuplazid helped tame hallucinations with few apparent side effects.
The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson’s disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.
On Thursday, the FDA said it had completed a review of these deaths and other adverse events that had been reported to the agency.
“Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis,” it stated.
Acadia Pharmaceuticals, the company that manufactures Nuplazid, welcomed the FDA findings. “Nothing is more important to Acadia than the wellbeing of the patients who use Nuplazid,” Steve Davis, the company’s president and chief executive officer, said in a statement. “We are very pleased with the FDA’s clear statement reaffirming Nuplazid’s positive benefit-risk profile.”
Dr. Paul Andreason, the physician who led the FDA’s initial medical review of Nuplazid, had warned at the time of Nuplazid’s approval that patients taking the drug during the company’s clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.
In its statement this week, the FDA noted that like other antipsychotics, the drug already has the agency’s most severe “black box” warning about the increased risk of death for the treatment of elderly dementia patients.
The agency also said its review had found “potentially concerning prescribing patterns,” such as the use of Nuplazid with other antipsychotic drugs or with medications that can cause heart issues. It urged health care providers to familiarize themselves with the warnings and precautions associated with Nuplazid when prescribing it to patients.
The FDA said it would continue to monitor reports of adverse events and encouraged patients and doctors to report any suspected side effects to the agency.
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This story has been updated with a statement from Acadia Pharmaceuticals.