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Dissemination of Information on Potentially Fatal Adverse Drug Reactions for Cancer Drugs From 2000 to 2002: First Results From the Research on Adverse Drug Events and Reports Project

Lisa A. Ladewski, Steven M. Belknap, Jonathan R. Nebeker, Oliver Sartor, E. Allison Lyons, Timothy C. Kuzel, Martin S. Tallman, Dennis W. Raisch, Amy R. Auerbach, Glen T. Schumock, Hau C. Kwaan, Charles L. Bennett

From the Veterans Affairs Midwest Center for Health Services and Policy Research, Lakeside Division, the Division of Hematology/Oncology of the Department of Medicine, the Center for Healthcare Studies, and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Medical Center; the Division of General Internal Medicine, Department of Medicine, The Feinberg School of Medicine, Northwestern University; the Center for Pharmacoeconomic Research, College of Pharmacy, University of Illinois at Chicago, Chicago, IL; the Veterans Affairs Salt Lake City Health Care System and the University of Utah School of Medicine, Salt Lake City, UT; the Stanley S. Scott Cancer Center and Section of Hematology/Oncology, Louisiana State University Health Sciences Center, New Orleans, LA; and the Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, University of New Mexico, Albuquerque, NM.

Address reprint requests to Charles L. Bennett, MD, PhD, VA Lakeside Medical Center, Division of Hematology/Oncology, Department of Medicine, 400 E Ontario St, Suite 205, Chicago, IL 60611; e-mail: cbenne{at}northwestern.edu.

Purpose: To describe the clinical findings, occurrence rates, causality evidence, and dissemination media for serious cancer drug–associated adverse drug reactions (ADRs) reported in the postmarketing setting.

Methods: ADRs were termed serious if they resulted in death or severe organ failure. ADR information for oncology drugs from package insert (PI) revisions, so-called Dear Doctor letters, and journal articles was evaluated to identify serious ADRs reported from 2000 to 2002. Timing and content of information disseminated was assessed.

Results: Twenty-five serious ADRs associated with 22 oncology drugs were identified after approval. Approximately half of these serious ADRs are associated with drugs approved before 1995. ADRs were described in articles in medical journals (17 ADRs), PI revisions (18 ADRs), and Dear Doctor letters (12 ADRs). PI revisions occurred less than 1 year after peer-reviewed publication for four ADRs. These revisions often differed for similar ADRs that occurred with drugs of the same class. Five of the seven ADRs lacking PI changes occurred with off-label use, for which PI change is not recommended by US Food and Drug Administration (FDA) policy. No cancer drug was withdrawn from the market during the observation period.

Conclusion: Our findings demonstrate that serious ADRs may be discovered as long as 36 years after a drug receives FDA approval. This suggests a need for continued vigilance and efficient strategies for dissemination of information about ADRs associated with cancer drugs.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 2003.

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