Opinion: The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains — SkimNews
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- FDA removed its clozapine registry on Feb. 24, 2025, ending a program that for more than 30 years required weekly blood draws logged into a national database before pharmacies could dispense refills.
- Clozapine is the only drug approved for treatment-resistant schizophrenia, the only one shown to reduce suicide in schizophrenia patients, and is associated with lower death rates than alternative antipsychotics, per the article.
- Only about 4% of U.S. schizophrenia patients receive clozapine, though roughly a third could benefit, with the shortfall sharpest still in childhood-onset schizophrenia, according to the author.
- Nitin Gogtay, a psychiatrist who ran clozapine trials at the National Institute of Mental Health for nearly two decades, could not find a single child psychiatrist across four academic centers willing to start the drug in a child with childhood-onset schizophrenia.
- The FDA still recommends clozapine blood tests but no longer requires them, shifting oversight from a federal registry to clinician judgment and informed patient choice.
- The author's group published findings that neutropenia risk on clozapine is concentrated in the early months of treatment and that adding lithium can lift neutrophil counts enough to keep children safely on the drug.
Why it matters: Roughly a third of U.S. schizophrenia patients would benefit from clozapine, yet only 4% receive it, with the gap widest in childhood-onset cases. Removing the FDA registry eliminates one bureaucratic obstacle, but the author documents zero willing prescribers across four academic centers — showing clinician fear of rare neutropenia, not paperwork, has been the real barrier all along.
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