Timing of New Black Box Warnings and Withdrawals for Prescription Medications

Abstract

Adverse drug reactions (ADRs) are believed to be a leading cause of death in the United States.¹ Prior to approval, drugs are studied in selected populations^2,3 for limited periods, possibly contributing to an increased risk of ADRs after approval. Pharmaceutical companies frequently market new drugs heavily to both patients and clinicians before the full range of ADRs is ascertained. Inadequate clinician reporting may delay detection of postmarketing ADRs; less than 10% of all ADRs are estimated to be reported to MEDWATCH,⁴ the Food and Drug Administration's (FDA's) voluntary postmarketing reporting system.