June 17, 2022: In 2018 FDA was concerned about “the numbers of reports of death and other serious adverse events” regarding this drug, which already carries a black box warning that there is “increased mortality in elderly patients with dementia-related psychosis.” To outweigh such serious safety risks, the benefits of this drug would need to be substantial. However, there is no such evidence.
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NCHR Testimony at FDA on Pimavanserin (Nuplazid) for Parkinson’s Patients with Psychosis
March 29, 2016. Because of concerns over the limited efficacy, the test used, and the high incidence of adverse events, NCHR urges FDA to not support the approval of pimavanserin [Nuplazid].
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