The Research on Adverse Drug Events and Reports

Contact me when new articles are published in these topic areas. A DVERSE DRUG AND DEVICE REactions (ADRs) account for as many as 100 000 deaths annually. 1 Prior to US Food and Drug Administration (FDA) approval, drugs are evaluated in well-designed and carefully monitored clinical trials. Only half of newly discovered serious ADRs are detected and documented in the Phy-sicians' Desk Reference within 7 years of drug approval. 2 Withdrawal of the cy-clooxygenase 2 inhibitor rofecoxib and cerivastatin has led to calls for new and independent approaches to postmarket-ing surveillance. Context In 1998, a multidisciplinary team of investigators initiated RADAR (Research on Adverse Drug events And Reports), a clinically based postmarketing surveillance program that systematically investigates and disseminates information describing serious and previously unrecognized adverse drug and device reactions (ADRs). Objective To describe the structure, operations, and preliminary findings from the RADAR project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration (FDA). Design After identifying a serious and unexpected clinical event suitable for further investigation, RADAR collaborators postulated clinical hypotheses and derived case series and incidence estimates from physician queries, published and unpublished clinical trials, published case reports, FDA databases, and manufacturer sales figures. Results RADAR investigators identified 16 types of serious ADRs among 1699 patients , of whom 169 (10%) died as a result of the reaction. Initial cases were identified by 7 RADAR investigators, 4 collaborating physicians, 2 attorneys, and by reviewing 3 published reports. Additional sources included queries of occupational health programs and medical directors of interventional cardiology laboratories (3 types of ADRs), published manuscripts and clinical trials (11 types of ADRs), review of medical records at a RADAR site (2 types of ADRs), unpublished clinical trial reports (3 types of ADRs), and reports from attorneys, family members, or patients (4 types of ADRs). Incidence estimates, ranging from 0.4% to 33%, were derived from 5 clinical trial reports , 2 physician queries, and 2 observational databases. Laboratory support for hypotheses included identification of 3 neutralizing antibodies and 3 histopathological findings. ADR reports were disseminated as 8 revised package inserts, 7 " dear doctor " letters, and 9 peer-reviewed articles. Conclusion A new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance systems and improve patient safety. miologic analyses of large numbers of ADRs, and review of voluntary case reports submitted to the Adverse Event Reports System (AERS) …