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.
OBJECTIVE
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 No cancer drug was withdrawn from the market during the observation period.


CONCLUSIONS
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.
Ladewski
Lisa A
LA
Veterans Affairs Midwest Center for Health and Policy Research, Lakeside Division,Northwestern University Medical Center, Chicago, IL 60611, USA.
Belknap
Steven M
SM
Nebeker
Jonathan R
JR
Sartor
Oliver
O
Lyons
E Allison
EA
Kuzel
Timothy C
TC
Tallman
Martin S
MS
Raisch
Dennis W
DW
Auerbach
Amy R
AR
Schumock
Glen T
GT
Kwaan
Hau C
HC
Bennett
Charles L
CL
D016907:Adverse Drug Reaction Reporting Systems; D000970:Antineoplastic Agents / Q000009:adverse effects*; D017277:Drug Approval; D011358:Product Surveillance, Postmarketing; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D000970:Antineoplastic Agents