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.
At a cost of around $1,400 a month Rexulti's makers, Otsuka and Lundbeck, are forecasting an additional $1 billion in annual sales, but there are serious questions about the harm-benefit balance of this drug, writes investigative journalist Robert Whitaker inThe decision may also reverse years of effort by the US Centers for Medicare and Medicaid Services to reduce the widespread off-label use of antipsychotics in residential care homes.
"The small benefits do not outweigh serious safety concerns," Public Citizen health researcher Nina Zeldes told the FDA's Advisory Committee prior to the approval."Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit." The chair of the advisory committee, Rajesh Narendran, did not respond to multiple requests for an interview to answer questions raised by this approval, while a spokesperson for the FDA's Center for Drug Evaluation and Research stated that"due to conflicting schedules and competing priorities," the FDA would be unable to respond.
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