Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002

Abstract

The Food and Drug Administration's Adverse Event Reporting System is the primary surveillance database used for the identification of safety problems of marketed drugs. Despite the limitations of underreporting, differential reporting, and uneven quality, submitted reports often allow the identification of serious adverse events that are added to the product labeling information. In rare instances, additional regulations, up to and including market removal, have been required. We encourage physicians, pharmacists, other health care professionals, and patients to continue to report serious suspected and known adverse drug reactions to manufacturers and the Food and Drug Administration.

Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

“…We identified the annual number of adverse events for 1992-2002 NMEs using the Spontaneous Reporting System (SRS) and Adverse Event Reporting System (AERS) databases maintained by the FDA (Rodriguez, Staffa, and Graham 2001;Wysowski and Swartz 2005). 15 The ADRs listed in these combined databases are voluntary, spontaneous reports filed primarily by health care professionals such as clinicians, physicians, and pharmacists.…”

Different Black Box Warning Labeling for Same-Class Drugs

“…6 Based on evidence from animal, clinical, or post-marketing surveillance studies and reports, the FDA decides whether acquisition and/or updating of a BBW is required. [7][8][9][10][11] Between 2005Between -2008, approximately 14% of safety labeling changes were BBW additions or revisions. 12 About 20% of approved chemical entities acquire a BBW label or are withdrawn from the market because of causing serious harms within 25 years from their approval.…”

Genome-wide approaches to identify pharmacogenetic contributions to adverse drug reactions

“…2 About 1% of marketed drugs are withdrawn or restricted post-marketing due to safety-related issues. 3 During 1994, ADRs affected over 2 million people in the United States, resulting in over 100 000 deaths. 4 In 2002, ADRs accounted for 6.5% of hospital admissions and 0.15% of subsequent deaths in the United Kingdom.…”