FDA Extends Clozapine REMS Deadlines for Prescribers, Pharmacies

Megan Brooks

November 20, 2015

Because of ongoing challenges in implementing the new clozapine (multiple brands) risk evaluation and mitigation strategy (REMS) program, the US Food and Drug Administration (FDA) is extending the November 23, 2015, deadline for prescriber certification and the December 14, 2015, deadline for pharmacy certification, the agency has announced.

The goal is to "help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained," the FDA said in a statement posted November 19 on its website.

The FDA said it is also "carefully evaluating" next steps regarding the December 14, 2015, predispense authorization (PDA) launch and will communicate the revised certification deadlines and additional information about the PDA launch "as soon as possible."

Clozapine is used to treat schizophrenia in patients whose symptoms are not adequately controlled with standard antipsychotic medication. It is also used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

In September, the FDA announced changes to requirements for monitoring, prescribing, dispensing, and receiving clozapine to address "continuing safety concerns" about severe neutropenia associated with the atypical antipsychotic.

As reported by Medscape Medical News at the time, the agency "clarified and enhanced" prescribing information for clozapine to better explain how to monitor patients for neutropenia and manage clozapine treatment, and it approved a new, shared-risk clozapine REMS program.

The shared program replaces the six existing clozapine registries maintained by individual clozapine manufacturers and requires that prescribers, pharmacies, and patients enroll in the single centralized program. It also requires healthcare providers who want to prescribe clozapine to outpatients or inpatients to be certified in the REMS program.

For now, the FDA advises that healthcare providers "prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the clozapine REMS program administrators."

The FDA encourages prescribers and pharmacies to continue to work with the clozapine REMS program administrators to resolve any issues and to continue their efforts to complete certification and update patient information to meet the requirements of the program.

Providers with questions or concerns about the clozapine REMS program are encouraged to contact the FDA by email at druginfo@fda.hhs.gov or by phone at 1.855.543.3784 or 301.796.3400.


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