🚨 To ensure continuity of care for patients taking clozapine, the FDA will temporarily exercise 'enforcement discretion' with respect to certain clozapine risk evaluation and mitigation strategy program requirements.
, the US Food and Drug Administration will temporarily exercise"enforcement discretion" with respect to certain clozapine risk evaluation and mitigation strategy program requirements., the FDA said it is aware that healthcare professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.
To address this issue, the FDA said it will now not object if inpatient pharmacies dispense a days' supply of clozapine that aligns with the patient's monitoring frequency. While clozapine can be highly effective in some patients, it also carries serious risks, including a decrease in neutrophil count, which can lead to severeAs a result, those taking the drug must undergo regular absolute neutrophil count monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
"We understand that difficulties with the clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities," the FDA says.
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