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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