An Antipsychotic Drug Gets FDA Green Light Despite Fourfold Higher Risk of Death

For medical professionals, the FDA’s move raises troubling questions about efficacy, safety, and regulatory diligence.

Manuel Balce Ceneta/AP Photo

A questionable green light from the U.S. Food and Drug Administration (FDA). Medical experts left confused and concerned.

This is the story surrounding brexpiprazole, branded as Rexulti: the first antipsychotic approved to treat agitation in Alzheimer’s patients despite alarmingly high death rates and poor results in clinical trials.