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The New ADHD Drug Carries Two Boxed Warnings and Will Be a Controlled Substance
['Dorothy Brooks']
Medical Daily
What the Two Boxed Warnings RequireThe prescribing information for the newly approved ADHD medication Simtriyo carries two boxed warnings, the strongest safety labeling the FDA applies, and one of them requires monitoring of every child who takes it.
Existing stimulant medications for ADHD are Schedule II, which carries monthly prescribing limits and has contributed to pharmacy shortages.
Those trials measured outcomes over roughly six weeks, so they describe short-term response rather than durability over the years many patients take ADHD medication.
No one should stop a current ADHD medication in anticipation of switching, and no one should start, stop or change any medication based on a news article.
If a child or adult taking any ADHD medication expresses thoughts of self-harm, contact the prescribing clinician promptly, and seek urgent care for immediate safety concerns.