FDA taking a fresh look at Parkinson's medication after hundreds of deaths linked to use of drug.

In 2016, the scientific community was optimistic about a new drug – Nuplazid – that appeared to promise some relief to patients who had to endure the misery of Parkinson’s psychosis – a symptom of Parkinson’s disease that caused patients to experience hallucinations and delusions. The drug, made by Arcadia Pharmaceuticals had shown in clinical trials that it offered substantial improvements over comparable drugs. But Dr. Paul Andreason, who supervised the FDA’s medical review of the drug, was concerned. In the limited clinical trials, patients taking Nuplazid experienced serious complications – including death – at twice the rate to patients in the placebo group.

Nonetheless, the FDA voted to go ahead with release, after a six week study of 200 patients. The drug hit the market in 2016. Patients and their loved ones rushed to buy and sales soared to $125 million by 2017.

And then reports of “adverse events” started. Those “adverse events” included falls, nausea, fatigue and death. And 1,000 reports that patients taking the drug continued to hallucinate.

The Institute for Safe Medication Practices released a study the same year linking 244 deaths to the use of Nuplazid. The same study noted that for hundreds of patients the drug was actually making things worse. FDA data shows the number of reported deaths has now risen to more than 700.

Doctors and researchers are convinced the drug was rushed to the market after only abbreviated testing. Diana Zuckerman, founder of the National Center for Health Research noted that since more adverse reports are voluntary – the actual number of adverse events may be substantially higher. “This is almost unheard of, ” Zuckerman noted. “You just don’t see this with most new drugs – you don’t see all these reports”.

Arcadia, the manufacturer, maintains the drug is safe and says that many patients taking the drug are have advanced Parkinson’s Disease and statistically more likely to die.

Andreason, however, saw it coming. “This is exactly what I thought was going to happen,” he noted.

Last week, in light of the adverse events reporting, the FDA is conducting a fresh evaluation of the drug.