Opinion: The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains

On Feb. 24, 2025, the FDA retired the elaborate monitoring program that had governed clozapine for over three decades. The author, a child psychiatrist, calls this welcome but says the problem was never really the paperwork. Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia, the only drug approved for that indication, the only one shown to reduce suicide, and it is associated with lower death rates than alternatives. Yet in the U.S., only about 4% of people with schizophrenia receive clozapine, though perhaps a third could benefit, and the rate should likely be higher in childhood-onset schizophrenia, which is even more treatment-resistant.

The old program required clinicians to enroll in an FDA-mandated registry, with patients undergoing regular blood draws (weekly at the start) logged into a national database before the next pharmacy release. The aim was to catch rare but severe neutropenia, but the program also kept the drug from those who need it. The deeper barrier, the author argues, is fear: clozapine's reputation for side effects, including a genuine but rare danger of neutropenia, which is more common in children than adults. The FDA can remove the registry, but it cannot remove that fear, and the author has watched capable clinicians avoid the drug for years, reaching for less effective alternatives even in the most vulnerable pediatric patients.