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# Clozapine REMS Updated
- URL: https://www.fdaweb.com/clozapine-rems-updated/
- Published: 2019-01-17T12:00:00.000Z
- Updated: 2026-09-15T00:55:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143176

FDA says it has approved a modification to the Risk Evaluation and Mitigation Strategy (REMS) for clozapine (Novartis’ Clozaril), an antipsychotic drug used to help improve symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. The [changes](https://www.fda.gov/drugs/drugsafety/ucm467560.htm?utm%5Fcampaign=FDA%20approves%20modification%20to%20the%20clozapine%20REMS%20-%20Drug%20Information%20Update&utm%5Fmedium=email&utm%5Fsource=Eloqua) take effect 2/28 and include a requirement that healthcare professionals prescribing clozapine, as well as pharmacies dispensing it, be certified in the clozapine REMS program.

An agency [announcement](http://app.info.fda.gov/e/es?s=2027422842&e=177256&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=44e176dc0f914fdc9ce0c85c2ed13a9d&elqaid=6498&elqat=1&ref=fdaweb.com) says that while the drug is beneficial for some patients, there are risks associated with it, Specifically, it says, clozapine can decrease the number of neutrophils that function in the body to fight infection. For that reason, FDA says, patients taking clozapine need to have their absolute neutrophil count monitored regularly. That monitoring requirement is the basis for the clozapine REMS.