FDA Pauses Clozapine REMS Program


New requirements resulted in long call wait times, which has led to patient access issues.

The FDA is temporarily suspending certain Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements to ensure continuity of care.

In August 2021, the FDA announced that had it the modified the Clozapine REMS program, requiring pharmacies that dispense clozapine to obtain a pre-dispense authorization and health care professionals to re-enroll their patients in the program. That change began Nov. 15, 2021.

Related: FDA Updates Clozapine REMS program.

But in a recent announcement, the FDA indicated there were difficulties with implementation of the new program, including a high call volume and long call wait times. Regulators are making two temporary changes to the program:

• Pharmacists may dispense clozapine without a REMS dispense authorization.

• Wholesalers may continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS

Clozapine, including generics and branded therapies (Clozaril, Fazaclo ODT, Versacloz), is an atypical antipsychotic medicine used to treat schizophrenia symptoms. The drug is also used in patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Clozapine, however, is associated with neutropenia, which can lead to serious and fatal infections. “Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable range,” the agency said in a statement.

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