A report about the still relatively new Parkinsons drug Nuplazid published in the November 1, 2017 edition of the Institute for Safe Medication Practices (ISMP) QuarterWatch, however, has raised some serious concerns about its safety.
Building upon that 2017 ISMP QuarterWatch report, more recently CNN covered this emerging drug safety issue in this April 2018 news story, “FDA worried drug was risky; now reports of deaths spark concern”.
An FDA Advisory Committee considered whether to recommend approval of the Parkinsons drug Nuplazid in March 2016. In more detail, according to the April 2018 CNN Investigates story:
Even some committee members who voted in favor of the drug expressed reservations, according to the hearing transcript. “I guess I’m hoping that the risks are going to be small, and I think the benefits for some of these people who are very sick and whose families are affected by this, I think they’re probably willing to take that risk,” one physician stated. Another committee member said she wouldn’t have voted for the drug’s approval if there had been a safe and effective alternative on the market. A third made a “plea” to the FDA to “consider a large observational study so we can ensure that, once it goes into real-world use, that the benefits will outweigh the risks.”
Nuplazid was thereafter approved by the FDA in April 2016, and became available to US patients in June 2016.
Returning to the April 2018 CNN news story about Nuplazid:
In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug’s launch and March 2017. The organization also noted that hundreds of reports suggested the drug was “not providing the expected benefit” or potentially worsening the condition….
Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700. As of last June, Nuplazid was the only medication listed as “suspect” in at least 500 of the death reports.
We will continue to watch developments concerning the safety profile of the Parkinsons drug Nuplazid, including possible regulatory action by the FDA.[Read article in full at original source]