FDA New Analysis on PD Psychosis Treatment

FDA New Analysis on PD Psychosis Treatment


On September 20, 2018, the FDA recently released results of a new analysis finding no new or unexpected safety risks associated with Nuplazid. The new analysis was initiated because of concerns raised in the media last spring, and reassures patients that they should continue to take Nuplazid as prescribed by their physician. The FDA report highlights a number of important concepts

  • Analysis of an increased risk of deaths in patients on Nuplazid is complicated by the fact that patients with Parkinson’s disease psychosis in general (even if not on Nuplazid) are at an increased risk of death from their complex medical condition.
  • Nuplazid is distributed through a patient support program and a specialty pharmacy network, which make concerted efforts to solicit adverse events from the prescribing physicians. These efforts, by definition, increase the number of adverse events and deaths reported, making it seem that more deaths are occurring than expected.
  • Safety concerns related to use of Nuplazid were noted and acknowledged prior to its approval by the FDA. This led to the inclusion of a Boxed warning on its label, present since its approval, which states that Nuplazid is associated with an increased risk of death in elderly patients with dementia-related psychosis. This warning is present on many other psychiatric medications as well. A discussion of the implications of this warning needs to take place between the physician, patient and family before the medication is prescribed.
  • Nuplazid, along with many other psychiatric medications, can cause QT prolongation, which indicates a tendency to an abnormal heart rhythm. This has been known since Nuplazid was approved. If at all possible, patients who are taking Nuplazid should therefore not also be on other medications that can prolong the QT interval.

Understanding the risks and benefits of Nuplazid is crucial. The medical community’s understanding of the risks and benefits however, has not changed since the medication was approved. Hallucinations and psychosis in Parkinson’s disease can be very problematic and markedly effect quality of life. If this is the case, patient, physician and family need to weigh the risks of the medication versus the potential for improvement in quality of life from decrease in hallucinations.

As with every aspect of Parkinson’s disease, there is much variability among patients, both in the presence and severity of symptoms and in an individual’s response to treatment. Therefore, the intensity of the hallucinations must be considered in the equation of whether or not to try Nuplazid. If hallucinations are mild, or not bothersome, taking a medication for them may not be necessary. In addition, once the medication is prescribed, its side effect profile and amount of benefit conferred must be continuously reviewed. If Nuplazid is not beneficial enough, patient, family and physician should discuss whether or not it should be continued.

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