5/1/2002 • Timing of New Black Box Warnings and Withdrawals for Prescription Medications

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.

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