Serious adverse drug reactions (sADRs) account for over 100,000 deaths annually. Investigation into barriers in identification and dissemination of sADR information for drugs is likely to have a direct benefit on patient safety, save lives, and identify areas for future policy changes. These considerations are especially important for cancer drugs, where the emphasis has been on accelerated FDA approval and shorter review times, raising concern that attention to sADRs may not be sufficient. In this study, we propose to describe all sADRs associated with oncology drugs that were identified between 1996 and 2003. We will conduct a comprehensive search of MedWatch (the FDA's voluntary reporting system), cooperative oncology group toxicity reports, MedLine and other electronic databases, abstracts from major health conferences, pharmacovigilance program websites from Europe, Australia, and Canada, """"""""Dear Doctor"""""""" letters, and FDA package label revisions for all sADRs for oncology drugs and compile and report complete case series information on each of these sADRs. Our preliminary analyses suggest that we will identify between 80 and 100 sADRs in our search. We will also describe dissemination efforts for the sADRs and identify the relevant milestones related to identification and dissemination of each sADR. These milestones include: the date of New Drug Application (NDA), date of submission of clinical packet for consideration of FDA approval, date of FDA approval, date of reporting of the first sADR to the FDA, date of reporting of the 10th case to the FDA, and date for which a comprehensive case series was developed and reported in the peer-reviewed literature, Dear Doctor letters, and package inserts. Additionally, we will assess the relationship between time from initial application for FDA approval to identification and reporting of the sADRs as a group and of several individual sADR characteristics. Our preliminary studies indicate that only 30% of previously unreported sADRs identified in the past five years have been described in the literature, and for the reported sADRs, dissemination efforts were often delayed. The findings of this study would: 1) provide more comprehensive and current information about sADRs associated with cancer drugs and 2) provide the first set of empirical data on barriers to identification and reporting of these important clinical events.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA102713-01
Application #
6673350
Study Section
Social Sciences, Nursing, Epidemiology and Methods 4 (SNEM)
Program Officer
Clauser, Steven
Project Start
2003-09-15
Project End
2005-08-31
Budget Start
2003-09-15
Budget End
2004-08-31
Support Year
1
Fiscal Year
2003
Total Cost
$455,494
Indirect Cost
Name
Northwestern University at Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
Belknap, Steven M; Aslam, Imran; Kiguradze, Tina et al. (2015) Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis. JAMA Dermatol 151:600-6
Allen, Katherine C; Champlain, Amanda H; Cotliar, Jonathan A et al. (2015) Risk of anaphylaxis with repeated courses of rasburicase: a Research on Adverse Drug Events and Reports (RADAR) project. Drug Saf 38:183-7
Isonishi, Ayami; Bennett, Charles L; Plaimauer, Barbara et al. (2015) Poor responder to plasma exchange therapy in acquired thrombotic thrombocytopenic purpura is associated with ADAMTS13 inhibitor boosting: visualization of an ADAMTS13 inhibitor complex and its proteolytic clearance from plasma. Transfusion 55:2321-30
Nardone, Beatrice; Saddleton, Elise; Laumann, Anne E et al. (2014) Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report. Pediatr Radiol 44:173-80
Gandhi, Mitul D; Evens, Andrew M; Fenske, Timothy S et al. (2014) Pancreatitis in patients treated with brentuximab vedotin: a previously unrecognized serious adverse event. Blood 123:2895-7
Raisch, Dennis W; Garg, Vishvas; Arabyat, Rasha et al. (2014) Anaphylaxis associated with gadolinium-based contrast agents: data from the Food and Drug Administration's Adverse Event Reporting System and review of case reports in the literature. Expert Opin Drug Saf 13:15-23
Edwards, B J; Laumann, A E; Nardone, B et al. (2014) Advancing pharmacovigilance through academic-legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis-a Research on Adverse Drug Events and Reports (RADAR) report. Br J Radiol 87:20140307
Holzem, Kassandra E; Nardone, Beatrice; Lomasney, Jon W et al. (2014) Superior vena cava obstruction associated with nephrogenic systemic fibrosis. J Drugs Dermatol 13:615-8
Bennett, Charles L; Jacob, Sony; Dunn, Brianne L et al. (2013) Ticlopidine-associated ADAMTS13 activity deficient thrombotic thrombocytopenic purpura in 22 persons in Japan: a report from the Southern Network on Adverse Reactions (SONAR). Br J Haematol 161:896-8
Bennett, Charles L; Djulbegovic, Benjamin; Norris, LeAnn B et al. (2013) Colony-stimulating factors for febrile neutropenia during cancer therapy. N Engl J Med 368:1131-9

Showing the most recent 10 out of 52 publications