Int J Med Sci 2012; 9(1):33-39. doi:10.7150/ijms.9.33 This issue Cite

Research Paper

Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations

Kaori Kadoyama1, Ikuya Miki2, Takao Tamura2, JB Brown3, Toshiyuki Sakaeda1,2✉, Yasushi Okuno1,3,4✉

1. Center for Integrative Education in Pharmacy and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan.
2. Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
3. Department of Systems Biosciences for Drug Discovery, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto 606-8501, Japan.
4. Kyoto Constella Technologies Co., Ltd., Kyoto 604-8156, Japan.

Citation:
Kadoyama K, Miki I, Tamura T, Brown JB, Sakaeda T, Okuno Y. Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations. Int J Med Sci 2012; 9(1):33-39. doi:10.7150/ijms.9.33. https://www.medsci.org/v09p0033.htm
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Abstract

Objective: The safety profiles of oral fluoropyrimidines were compared with 5-fluorouracil (5-FU) using adverse event reports (AERs) submitted to the Adverse Event Reporting System, AERS, of the US Food and Drug Administration (FDA).

Methods: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving 5-FU and oral fluoropyrimidines were analyzed. Standardized official pharmacovigilance tools were used for the quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean.

Results: Based on 22,017,956 co-occurrences, i.e., drug-adverse event pairs, found in 1,644,220 AERs from 2004 to 2009, it was suggested that leukopenia, neutropenia, and thrombocytopenia were more frequently accompanied by the use of 5-FU than capecitabine, whereas diarrhea, nausea, vomiting, and hand-foot syndrome were more frequently associated with capecitabine. The total number of co-occurrences was not large enough to compare tegafur, tegafur-uracil (UFT), tegafur-gimeracil-oteracil potassium (S-1), or doxifluridine to 5-FU.

Conclusion: The results obtained herein were consistent with clinical observations, suggesting the usefulness of the FDA's AERS database and data mining methods used, but the number of co-occurrences is an important factor in signal detection.

Keywords: adverse events, AERS, 5-fluorouracil, capecitabine, pharmacovigilance.


Citation styles

APA
Kadoyama, K., Miki, I., Tamura, T., Brown, JB., Sakaeda, T., Okuno, Y. (2012). Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations. International Journal of Medical Sciences, 9(1), 33-39. https://doi.org/10.7150/ijms.9.33.

ACS
Kadoyama, K.; Miki, I.; Tamura, T.; Brown, JB.; Sakaeda, T.; Okuno, Y. Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations. Int. J. Med. Sci. 2012, 9 (1), 33-39. DOI: 10.7150/ijms.9.33.

NLM
Kadoyama K, Miki I, Tamura T, Brown JB, Sakaeda T, Okuno Y. Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations. Int J Med Sci 2012; 9(1):33-39. doi:10.7150/ijms.9.33. https://www.medsci.org/v09p0033.htm

CSE
Kadoyama K, Miki I, Tamura T, Brown JB, Sakaeda T, Okuno Y. 2012. Adverse Event Profiles of 5-Fluorouracil and Capecitabine: Data Mining of the Public Version of the FDA Adverse Event Reporting System, AERS, and Reproducibility of Clinical Observations. Int J Med Sci. 9(1):33-39.

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