FDA reports on Clozapine REMS

FDA reports on Clozapine REMS

An FDA (Food and Drug Administration) committee voted yesterday against Clozapine Risk Evaluation and Mitigation Strategy (REMS) monitoring program after hearing from physicians and other clinicians, patients, and caregivers who said access to this effective schizophrenia medication was full of unnecessary steps.

“The REMS program, while well-intentioned and -designed, does create a barrier to prescribers and patients using clozapine,” said Dr. Erickson-Ridout, an inpatient psychiatrist and researcher for Kaiser Permanente. 

Dozens of patients and their caregivers spoke to the FDA panel about the problems they experienced from being denied a refill for Clozaril/Clozapine due to missing REMS paperwork. 

Look for future changes in the FDA mandated REMS program for patients who are prescribed Clozaril and the psychiatrists that help them.

For more information, see the Psychiatric News article “Clozapine Risks Drop Sharply Within Months, May Warrant Less Monitoring.”