The Unfinished Science of Boxed Drug Warnings - Summary - MDSpire

The Unfinished Science of Boxed Drug Warnings

  • By

  • John G. Rizk

  • John C. Lewin

  • May 22, 2026

  • 0 min

Share

Objective:

To examine the impact of the FDA's boxed warning on montelukast prescribing practices.

Key Findings:
  • 30% relative reduction in montelukast initiation following the boxed warning.
  • 5% relative reduction in montelukast prevalence post-warning.
  • Absolute changes in prescribing were small, with a decline of 1 to 2 fewer new prescriptions per 1000 patients.
Interpretation:

Limitations:
  • Limited awareness among clinicians and patients may have reduced the warning's impact.
  • Uncertainty regarding the causal association between montelukast and neuropsychiatric events may hinder prescribing changes.
Conclusion:

Original Source(s)

The Unfinished Science of Boxed Drug Warnings

  • by John G. Rizk, John C. Lewin

  • May 22, 2026

Related Content

FDA Expands ASCENIV Pediatric Use

Label change follows completion of required pediatric evaluation and updates prior age restrictions for treatment eligibility.

Ensitrelvir Reduced COVID After Household Exposure

In SCORPIO-PEP, symptomatic COVID-19 occurred in 3% vs 9% of household contacts by day 10.

A dynamic vascular–inflammatory–fibrotic loop in systemic sclerosis: an integrative immuno-vascular framework