FDA Sets for New Prescribing and Monitoring Requirements for Schizophrenia Drug Clozapine

The U.S. Food and Drug Administration (FDA) is making changes to the requirements for prescribing, monitoring, dispensing, and receiving the schizophrenia medicine clozapine, to address safety concerns about a serious blood condition called severe neutropenia.

Severe neutropenia is a dangerously low number of neutrophils, the white blood cells that help fight infection. The condition can be life-threatening, the FDA warns. Neutropenia can make an individual vulnerable to bacterial and fungal infections, the Mayo Clinic says.

Clozapine (brand names include Clozaril, FazaClo, Versacloz, Clopine, CloZApine Synthon, and Denzapine) is prescribed to treat schizophrenia in patients who do not respond adequately to standard antipsychotic treatments. Symptoms of schizophrenia include hearing voices, seeing things that are not there, and being suspicious or withdrawn, the FDA says. Clozapine is also effective in reducing the risk of repeated suicidal behavior in patients with schizophrenia or schizoaffective disorder. The FDA previously communicated safety information associated with clozapine in February 2011.

There are two major changes to the requirements for prescribing clozapine. First, the FDA has clarified and enhanced the prescribing information for clozapine to explain how to monitor patients for neutropenia and manage clozapine treatment. Second, the FDA has approved a new, shared risk evaluation and mitigation strategy (REMS) for clozapine. The Clozapine REMS Program will improve monitoring and management of patients with severe neutropenia. The shared REMS is also expected to reduce the burden and possible confusion of having separate registries for individual clozapine medicines. All requirements for prescribing, dispensing, and monitoring clozapine medicines are now incorporated into the Clozapine REMS Program.

The new Clozapine REMS Program replaces six existing clozapine registries maintained by individual manufacturers. Prescribers, pharmacies, and patients will now enroll in a single centralized program. Patients who are currently being treated with clozapine will be automatically transferred to the Clozapine REMS Program. Prescribers and pharmacies will be required to be certified in the Clozapine REMS Program in order to prescribe and dispense clozapine. A specific transition schedule takes effect starting October 12, 2015.

The monitoring recommendations for neutropenia caused by clozapine treatment have changed. Because clozapine can decrease the number of neutrophils in the blood, health care professionals will now monitor neutropenia by the absolute neutrophil count (ANC) only, rather than in conjunction with the white blood cell count. In addition, in the Clozapine REMS Program, the requirements for ANC are being modified so that patients will be able to continue on clozapine treatment with a lower ANC, a change that will allow continued treatment for a greater number of patients. Patients with benign ethnic neutropenia (BEN), which previously made them ineligible for clozapine treatment, will now be able to receive the drug. The revised prescribing information facilitates prescribers’ ability to make individualized treatment decisions if they determine that the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia, especially in patients for whom clozapine may be the treatment of last resort.

The FDA urges health care professionals, patients, and caregivers to report side effects involving clozapine medications to the FDA MedWatch program: http://www.fda.gov/Safety/MedWatch.

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