P3 (无法标黄)Timing of New Black Box Warnings and Withdrawals for Prescription Medications.pdf

ORIGINAL CONTRIBUTION Timing of New Black Box Warnings and Withdrawals for Prescription Medications Karen E. Lasser, MD, MPH Context Recently approved drugs may be more likely to have unrecognized ad- Paul D. Allen, MD, MPH verse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. Steffie J. Woolhandler, MD, MPH Objective To determine the frequency and timing of discovery of new ADRs de- David U. Himmelstein, MD scribed in black box warnings or necessitating withdrawal of the drug from the market. Sidney M. Wolfe, MD Design and Setting Examination of the Physicians’ Desk Reference for all new chemi- David H. Bor, MD cal entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a DVERSE DRUG REACTIONS prior black box warning). (ADRs) are believed to be a Main Outcome Measures Frequency of and time to a new black box warning or leading cause of death in the drug withdrawal. AUnited States.1 Prior to ap- Results A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) proval, drugs are studied in selected acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) ac- populations2,3 for limited periods