FDA's Fast-Track for Rexulti Raises Concerns

According to a recent SciTechDaily article, the FDA's questionable fast-tracking of the antipsychotic drug Rexulti. The drug intended for elderly dementia patients has raised concerns about the approval process and influence of commercial interests on patient advocacy groups. Despite limited clinical benefits and an increased mortality risk, Rexulti received approval for treating agitation in elderly dementia patients. The drug's manufacturers, Otsuka and Lundbeck, anticipate large profits, but journalists raise questions about the drug's harm-benefit balance. The FDA's decision may also undermine years of efforts by the CMS to reduce off-label use of antipsychotics in residential care homes.