Pharmaceutical

Schizophrenia drugs’ label includes black box warning for blood condition

black box warning graphic WL Schizophrenia drugs label includes black box warning for blood conditionThe safety labels of the schizophrenia drug clozapine have been updated to include a new black box warning for a serious blood condition known as severe neutropenia. The new labels also include updated requirements for monitoring, prescribing, dispensing and receiving the drug.

The updated black box warning was added to the safety labels of brand-name clozapine, which include Clozaril, FazaClo, Zaponex, and Clopine. The medication is used to treat borderline personality disorder, paranoid disorder, and schizophrenia. Clozapine is also used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

Neutropenia is a condition in which there is a dangerously low number of neutrophils, which are white blood cells that help fight infections. Severe neutropenia can lead to serious infection and death.

The safety labels have also been updated to include a new listing under CONTRAINDICATIONS for patients who have serious hypersensitivity to clozaril; as well as new listings under WARNINGS AND PRECAUTIONS for severe neutropenia. A new ADVERSE REACTION for retrograde ejaculation has also been added as well as noting SPECIAL POPULATIONS for hospice patients that monitoring of the medication may be reduced in frequency to once every six months.

The updated requirements for monitoring, prescribing, dispensing and receiving clozaril involves two parts – one that clarifies and enhances prescribing information for the drug that explains how to monitor patients for neutropenia and manage the treatment. The second involves a new, shared risk evaluation and mitigation strategy, or REMS, designed to improve the monitoring and management of patients with severe neutropenia.

Sources:
FDA
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