Wednesday, November 20, 2024

FDA Panel Votes 14-1 Against Clozapine REMS

A panel convened by the Food and Drug Administration (FDA) voted overwhelmingly yesterday against key provisions of the Clozapine Risk Evaluation and Mitigation Strategy (REMS) after hearing from clinicians, patients, and caregivers who said access to this effective schizophrenia medication was thwarted by red tape.

The REMS for clozapine is designed to monitor for the relatively rare risk of neutropenia, a potentially deadly reduction in white blood cells.

The panel voted 14-1 against the REMS requirement that prescribers document and pharmacies verify patients’ absolute neutrophil counts (ANC) before dispensing clozapine. The panel also voted 14-1 against the need for educating prescribers and pharmacists on the risk of clozapine-induced severe neutropenia and ANC monitoring.

“I do not believe that the REMS’ approach to documenting and enforcing is serving the health of the patients or the needs of the community,” said panelist Sascha Dublin, M.D., Ph.D., an epidemiologist who studies the health effects of prescription medications for Kaiser Permanente. “I hope we can find better ways to support appropriate monitoring that don’t have a punitive and technocratic approach.”

The FDA is not required to follow the recommendations from this joint meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee, but it often does.

Kathryn K. Erickson-Ridout, M.D., a member of APA’s Council on Quality Care, testified on behalf of APA. “I have been treating patients with treatment-resistant schizophrenia for 12 years and have seen the life-transforming benefit of this medication—controlling otherwise treatment-resistant psychotic symptoms and providing cognitive clarity.

“The REMS program, while well-intentioned and -designed, does create a barrier to prescribers and patients using clozapine,” said Erickson-Ridout, who is also an inpatient psychiatrist and researcher for Kaiser Permanente. The barriers posed by the REMS can lead to interruptions in access to clozapine, often with disastrous results, she said.

Dozens of patients and their caregivers offered testimonials of rapid decompensation, self-harm, and relapsed psychosis after being denied a refill for their prescribed clozapine—often despite completing required bloodwork—due to missing paperwork or lack of training among pharmacy personnel. Most patients simply could not find a willing clinician, pharmacy, and/or lab to prescribe the drug or complete the required testing.

Tiffany R. Farchione, M.D., director of the FDA’s Division of Psychiatry, testified that 22% to 37% of people with schizophrenia have treatment-resistance illness. Yet only 4% to 5% of patients with schizophrenia receive clozapine, Erickson-Ridout noted in her testimony. She added that surveys have found that since the last change to the Clozapine REMS in November 2021, 66% of prescribers have reported trouble getting the drug for patients.

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

(Image: Getty Images/iStock/Grandbrothers)




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