The Food and Drug Administration is changing requirements regarding the medication clozapine because of issues regarding severe neutropenia, a potentially life-threatening blood condition.

Used to treat schizophrenia and schizoaffective disorder, clozapine is an antipsychotic medication prescribed when standard antipsychotics are not effective at treating the patient. However, clozapine also can reduce the number of neutrophils, white blood cells that fight infections, in the blood, leading to severe neutropenia.

The FDA is conducting a two-part change to the clozapine treatment requirements. The prescribing information for clozapine has been changed to specify how to manage treatment and to monitor patients for neutropenia. Second, a new risk evaluation and mitigation strategy called the Clozapine REMS Program was created. All patients taking clozapine will be transferred to this program, and doctors and pharmacies must be certified in Clozapine REMS to prescribe and provide clozapine.

“The shared REMS is expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines. The requirements to monitor, prescribe, dispense, and receive all clozapine medicines are now incorporated into the Clozapine REMS Program,” the FDA said in the press release.

Find the full press release on the FDA website.

lfranki@frontlinemedcom.com

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