5/1/2002 • Timing of New Black Box Warnings and Withdrawals for Prescription Medications
Karen E. Lasser, MD, MPH; Paul D. Allen, MD, MPH; Steffie J. Woolhandler, MD, MPH; David U. Himmelstein, MD; Sidney M. Wolfe, MD; David H. Bor, MD
Journal of the American Medical Association
JAMA. 2002;287:2215-2220
Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.
