Despite its increased risk of death and minimal clinical benefits, the FDA fast-tracked the approval of the antipsychotic drug brexpiprazole for elderly dementia patients. This controversial decision, which may bolster drug companies’ profits, has raised concerns about the FDA’s current approval standards and the influence of commercial interests on patient advocacy groups.
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 in a recent paper published 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.” In a vote, nine of the FDA committee’s 10 members believed there was sufficient data to identify a population in whom benefits outweighed the drug’s risks. But even among those voting yes, several advisors expressed concern about its use in patients with mild symptoms. Some stressed the need for individualized risk-benefit evaluation in collaboration with patients’ families.
Erick Turner, a former FDA reviewer and professor of psychiatry at Oregon Health & Science University, said that clinicians’ responses to the approval will likely vary according to their current beliefs about prescribing antipsychotics to Alzheimer’s patients.