As of Feb 24, 2025, prescribers, pharmacies, and patients are no longer required to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine or to report results of absolute neutrophil count (ANC) blood tests before dispensing the drug. FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. The announcement came after a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee held late last year. During that meeting committee members determined that REMS wasn’t necessary and actually may interfere with access to clozapine.

On its website, the FDA said, “Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine.” In the months ahead, the agency will work with clozapine manufacturers on updating prescribing information, including eliminating mandatory reporting of ANC blood tests. In the meantime, the FDA has told these companies to formally submit a modification to eliminate the clozapine REMS.

The REMS program mandated that patients have weekly blood draws in the first 6 months of treatment, then every 2 weeks for 6 more months. Prescribers then were required to send ANC numbers online or via fax to the FDA. Only then was a REMS-registered pharmacy allowed to dispense clozapine. Both prescribers and pharmacy staff had to complete special training to be certified to prescribe and dispense the medication.

This particularly affects patients in developmentally disabled (DD) homes and community-integrated living arrangements (CILAs), where – although they still have to conduct blood tests – pharmacists are no longer required to withhold medication dispensing until they receive lab test results.

The risk for severe neutropenia, with an ANC count less than 500 cells/μL, still exists with clozapine. This condition is associated with an increased risk of infection, which could be fatal. However, this occurs in a small number of clozapine patients.

There is support among practitioners for this decision. For instance, Psychiatric Times’ editor in chief John J. Miller, MD, said in his publication that “this is great news for both patients and prescribers.” He added that the REMS requirement was an impediment to clozapine use. However, he also stressed the importance of informed consent and patient education. 

Read more here.