FDA Addresses Neutropenia Risk of Clozapine Treatment

In an effort to address safety concerns regarding severe neutropenia, the FDA has made changes to requirements for monitoring prescribing, dispensing, and receiving the schizophrenia medicine clozapine.

In an effort to address safety concerns regarding severe neutropenia, the FDA has made changes to requirements for monitoring prescribing, dispensing, and receiving the schizophrenia medicine clozapine.

Clozapine may improve the symptoms of schizophrenia patients who do not respond to standard antipsychotic treatments and may also be effective in reducing the risk of suicidal behavior. However, severe neutropenia, which can be caused by the treatment, can be life-threatening.

A drug safety announcement by the FDA includes the announcement of a new risk evaluation and mitigation strategy, called Clozapine REMS Program, that improves monitoring and management of patients with severe neutropenia.

Clozapine can cause severe neutropenia as a result of decreasing the number of neutrophils, which help fight infections, in the blood. The Clozapine REMIS Program will monitor neutropenia through absolute neutrophil count. Patients being treated with clozapine will automatically be transferred to the REMS Program.

“The shared REMS is also expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines,” according to the FDA.

In addition, the FDA has modified treatment requirements so that patients who were previously not eligible for clozapine because of benign ethnic neutropenia, can now receive the medicine.

“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 antipsychotic of last resort,” the FDA announced.