The U.S. FDA has removed the risk evaluation and mitigation strategy (REMS) program for clozapine tablets — although a risk of neutropenia still remains.
Clozapine is an antipsychotic marketed under the brand names Clozaril and Versacloz as well as being available as a generic oral drug. It was first approved in 1989 as a schizophrenia treatment.
The drug has the potential to cause severe neutropenia: an abnormally low quantity of neutrophils (a type of white blood cell), which puts patients at risk of infection. In its reevaluation of clozapine REMS, the FDA determined that the REMS program was unnecessary and that labeling was sufficient to reduce the risk of neutropenia. This was based on the changes the FDA found in the risk of severe neutropenia, in health care providers’ knowledge of the risk, and in the extent that health care providers monitor patients’ ANC results since clozapine was approved in 1989.
The REMS program required prescribers, pharmacies, and patients to enroll in a restricted distribution program and report absolute neutrophil count (ANC) before patients could receive clozapine. The FDA believes that by removing REMS, patients will gain better access to clozapine and there will be a lower burden on the health care delivery system.