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According to data submitted to federal health regulators, more than 5,000 adverse event reports and more than 700 deaths have been linked to side effects of Nuplazid, a new-generation Parkinson’s disease drug that has only been on the market for two years.
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, according to a recent CNN report.
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.
The drug has 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.
According to the CNN report, scientific advisors who examined the risk profile of Nuplazid warned that a disturbing number of deaths appeared in the clinical trials conducted before the drug was even approved in the United States.
In addition, Dr. Paul Andreason, who was the head of the FDA’s medical review of the drug, warned the agency that the manufacturer had not convinced him that the benefits of the drug outweighed the risks, raising questions about whether a Nuplazid recall may be necessary.
Andreason also noted that three previous studies had not shown that the drug was particularly effective, despite one clinical trial of only 200 patients that did. However, an FDA advisory committee recommended approval of the drug.
Since the drug was approved the for the treatment of hallucinations and delusions linked to Parkinson’s disease psychosis (PDP), Nuplazid brought in 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.
The problems also included reports of falls, insomnia, nausea, and fatigue.
Acadia responded to the Nuplazid concerns in a lengthy statement, defending the drug’s safety profile and effectiveness.
“Over 50% of poeple living with Parkinson’s disease (PD) will experience hallucinations and delusions over the course of the disease,” the company’s response states. “PDP is more typically seen on the advanced stages of PD, in elderly patients with numerous medical comorbidities. Consequently, these patients are at a high overall risk of morbidity and mortality.”