Dis­miss­ing crit­i­cal re­ports on pa­tient deaths, FDA says safe­ty/ef­fec­tive­ness of Nu­plazid holds up un­der re­view

Not long af­ter Aca­dia’s Nu­plazid hit the mar­ket, green light­ed by the FDA de­spite its own in-house con­cerns about a pos­si­ble link to pa­tient deaths, the drug re­mained a light­ning rod for con­tro­ver­sy. CNN high­light­ed more deaths for the ap­proved drug and ProP­ub­li­ca held it up as a prime ex­am­ple of what it viewed as the FDA’s will­ing­ness to rush risky drugs to pa­tients with­out prop­er vet­ting.

But af­ter look­ing over the da­ta and con­sid­er­ing its ef­fec­tive­ness, the FDA says there’s no rea­son to change its bot­tom line: “The drug’s ben­e­fits out­weigh its risks for pa­tients with hal­lu­ci­na­tions and delu­sions of Parkin­son’s dis­ease psy­chosis.”

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