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# FDA Expects Operational Clozapine REMS by Year-end
- URL: https://www.fdaweb.com/fda-expects-operational-clozapine-rems-by-year-end/
- Published: 2016-04-27T12:00:00.000Z
- Updated: 2026-09-14T20:57:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135505

FDA says it believes that most issues identified by clozapine manufacturers when the drug’s REMS (Risk Evaluation and Mitigation Strategy) program was first implemented in 2015 have been resolved. In a post-market drug safety [report](http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm497790.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), the agency says it is continuing to work with manufacturers to develop a timeline for full implementation of the shared clozapine REMS program, including the pre-dispense authorization and prescriber and pharmacy certification requirements. “The goal is to have the REMS fully operational by the end of 2016,” the report says.

The update says that while the schizophrenia drug is beneficial for some patients, there are risks associated with it, such as decreasing the number of neutrophils in the blood. When neutrophils are significantly decreased, it says, severe neutropenia can result, leaving a patient prone to infections. Thus, patients taking clozapine need to have their absolute neutrophil count monitored regularly and it is that monitoring that is the basis for the REMS.