FDA Implements New Requirements for Monitoring, Prescribing Clozapine
October 2, 2015 | Strategic Insights for Ambulatory Care
New requirements from the U.S. Food and Drug Administration (FDA) will change how providers monitor patients and prescribe the schizophrenia medication clozapine, according to a September 15, 2015, FDA safety alert. FDA has updated the monitoring requirements in response to concerns about a potentially fatal condition, severe neutropenia, which has been reported in some patients taking the drug. Additionally, FDA approved a new shared risk evaluation and mitigation strategy (REMS) program that will improve monitoring and management of patients with severe neutropenia.