Clozapine for Childhood Schizophrenia: Access and Risks

What did the FDA change about clozapine access?

In a September 4 commentary, psychiatrist Nitin Gogtay argued that clinicians' concerns about clozapine continue to restrict its use in children with severe schizophrenia. His article raises an access question: whether removing administrative barriers will translate into more appropriate prescribing. It is an expert perspective, rather than a new clinical trial or evidence that prescribing has already increased. [STAT commentary](https://www.statnews.com/2026/09/04/clozapine-children-schizophrenia-neutrophil-fda-monitoring/)

The FDA formally removed the Clozapine Risk Evaluation and Mitigation Strategy, or REMS, effective June 13, 2025. Prescribers, pharmacies and patients no longer have to enroll or submit absolute neutrophil count results to that program before dispensing. The agency concluded that labeling and clinical monitoring could manage the risk of severe neutropenia, a potentially dangerous reduction in infection-fighting white blood cells. It expected the change to improve access, but that expectation does not establish how much access has improved. [FDA safety communication](https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-risk-evaluation-and-mitigation-strategy-rems-program-antipsychotic-drug-clozapine)

When can clozapine help children with schizophrenia?

Britain's National Institute for Health and Care Excellence recommends offering clozapine to children and young people whose schizophrenia has not responded adequately to at least two different antipsychotics, each given at adequate doses for six to eight weeks. Before identifying treatment resistance, clinicians should reassess the diagnosis, medication adherence, treatment duration and other possible explanations for persistent symptoms. Psychological treatment and family support also remain part of care. [NICE recommendations](https://www.nice.org.uk/guidance/cg155/chapter/recommendations)

A randomized, double-blind trial published in Biological Psychiatry in 2008 compared clozapine with high-dose olanzapine in 39 participants aged 10 to 18 who were resistant or intolerant to at least two antipsychotics. Over 12 weeks, 66% of the clozapine group met the study's response criteria, compared with 33% receiving olanzapine. Those criteria measured symptom improvement, not cure. Both groups experienced significant weight gain and metabolic abnormalities. The small sample and short follow-up limit conclusions about uncommon harms, lasting recovery and outcomes in younger children. [Randomized pediatric trial](https://pubmed.ncbi.nlm.nih.gov/17651705/)

In the United States, the Clozaril label states that pediatric safety and effectiveness have not been established. Prescribing to children therefore remains off-label and requires an individualized specialist assessment; removing REMS did not create a pediatric approval. [Clozaril prescribing information](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90876802-0e3a-44c9-9ff7-1754dfbe736a)

What monitoring is still needed during clozapine treatment?

The prescribing information recommends a baseline absolute neutrophil count, followed by weekly testing during the first six months when counts remain in the normal range. Testing generally moves to every two weeks during months seven through twelve, then monthly. Abnormal results or treatment interruptions can change that schedule. Families should follow their prescribing team's plan. [Clozaril monitoring recommendations](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90876802-0e3a-44c9-9ff7-1754dfbe736a)

Blood counts address only one risk. Clozapine can also cause heart inflammation, seizures, low blood pressure and severe slowing of bowel function. Fever or signs of infection warrant prompt medical contact; chest pain, breathing difficulty or severe abdominal symptoms require urgent assessment. Weight, glucose and blood lipids also need attention. [Clozaril safety information](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90876802-0e3a-44c9-9ff7-1754dfbe736a)