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FDA approved Rexulti to be the first antipsychotic for treating agitation in elderly patients with dementia

In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia.
United States Rajesh Narendran Nina Zeldes Lon Schneider Robert Whitaker Oderick Turner

How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death

In trials, brexpiprazole failed to provide a clinically meaningful benefit and it increased mortality, but the FDA fast tracked its approval and the sponsor predicts $1bn in annual sales. Robert Whitaker investigates the first licensed antipsychotic for treating agitation in elderly patients with dementia For years, health officials have tried to rein in the prescribing of atypical antipsychotics to elderly patients with dementia. The practice has been entirely โ€œoff labelโ€ yet widespread. Th...
United Kingdom United States Robert Whitaker Rajesh Narendran Jim Scott Lon Schneider
Source: bmj.com

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