Rate increased sharply after press release announcing leucovorin label would be updated to include cerebral folate deficiency
FRIDAY, Aug. 21, 2026 (HealthDay News) — Leucovorin dispensing to children increased 700 percent from December 2024 to December 2025, according to a research letter published in the Aug. 13 issue of the New England Journal of Medicine.
Kao‑Ping Chua, M.D., Ph.D., from the University of Michigan Medical School in Ann Arbor, and colleagues examined nationwide changes in leucovorin dispensing among children aged 0 to 17 years after the Sept. 22, 2025, press release, which announced that the U.S. Food and Drug Administration would update the leucovorin label to include cerebral folate deficiency, sometimes accompanied by symptoms of autism. The leucovorin dispensing rate was calculated for each week from Dec. 29, 2024, through Dec. 14, 2025.
Overall, 150,026 leucovorin prescriptions were dispensed to 47,394 children during the study period. The researchers observed an increase in the leucovorin dispensing rate between the weeks of Dec. 29, 2024, and Sept. 14, 2025, from 1.0 to 4.6 per 100,000 children. The rate increased further from 6.7 to 8.0 per 100,000 children between the weeks of Sept. 21, 2025, and Dec. 14, 2025. The level change was 3.0 per 100,000 children during the week of Sept. 21, 2024. The slope change per week was 0.04 per 100,000 children. The level increase was small among adults. The greatest level changes were seen among children aged 6 to 11 years and for those in the South.
“Our findings demonstrate the power of the federal government to influence medical practice,” Chua said in a statement. “Given this power, it is important that the government”s messaging about medications is based on rigorous evidence.”
One author disclosed ties to Greylock McKinnon and Associates and Keystone Consulting.
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