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FDA's Fast-Track for Rexulti Raises Concerns

CMS efforts to reduce use of unnecessary antipsychotics in nursing homes may conflict with marketing efforts for the drug.

Rexulti
Rexulti

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.

Some believe that the FDA's approval standards have lowered over the years, setting a dangerous precedent for future drug approvals for vulnerable patient groups. While some FDA committee members voted in favor of Rexulti's approval, concerns remain about its use, especially in patients with mild symptoms. Patient advocacy groups supporting the approval have ties to pharmaceutical companies, raising questions about commercial interests influencing the decision. 

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