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Serious Blood Condition Prompts FDA to Establish New Prescribing Requirements for Schizophrenia Drug Clozapine

Filed September 16th, 2015 F.A. Kelley

The U.S. Food and Drug Administration (FDA) has announced changes to prescribing and monitoring requirements for the schizophrenia medicine clozapine, in order to address safety concerns about the serious blood condition severe neutropenia.

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

Clozapine is prescribed to treat schizophrenia in patients who do not respond adequately to standard antipsychotic treatments and the drug is also effective in reducing the risk of repeated suicidal behavior in patients with schizophrenia or schizoaffective disorder. Clozapine brand names include Clozaril, FazaClo, Versacloz, Clopine, CloZApine Synthon, and Denzapine. Schizophrenia symptoms include hearing voices, seeing things that are not there, and being suspicious or withdrawn, the FDA says. An earlier safety communication about risks associated with clozapine was issued in February 2011.

The September 15 safety communication describes two major changes to the prescribing and monitoring requirements for clozapine. The FDA has clarified information on how to monitor patients for neutropenia and manage clozapine treatment, and the agency 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 will reduce the difficulties and possible confusion of having separate registries for individual clozapine and medicines. All requirements for prescribing, dispensing, and monitoring clozapine medicines are now incorporated into the Clozapine REMS Program.

The new REMS program replaces six clozapine registries maintained by individual drug makers. All clozapine prescribers, pharmacies, and patients will now be enrolled 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 goes into effect on October 12, 2015.

The monitoring recommendations for neutropenia caused by clozapine treatment have changed. 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 have been modified so that patients with a lower ANC will be able to continue on clozapine treatment. This change will allow continued treatment for a greater number of patients. Patients with a form of neutropenia known as benign ethnic neutropenia (BEN), who were previously not eligible for clozapine treatment, will now be able to receive the medicine. The revised prescribing information enhances the prescriber’s ability to make individualized treatment decisions if the prescriber determines that the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia, especially in patients for whom clozapine may be the antipsychotic of last resort.

The FDA urges health care professionals, patients, and caregivers to report side effects involving clozapine medications to the FDA MedWatch program:


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