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Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.
Jpn J Clin Oncol. 2015 Jun; 45(6):588-94.JJ

Abstract

OBJECTIVE

All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry.

METHODS

We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action.

RESULTS

Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance.

CONCLUSION

All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions.

Authors+Show Affiliations

Human Genome Center, Institute of Medical Science, The University of Tokyo, Tokyo Division of Internal Medicine, Jyoban Hospital, Tokiwakai jin_ichi@hotmail.com.Division of Internal Medicine, Jyoban Hospital, Tokiwakai Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, The University of Tokyo, Tokyo.Division of Hematology, Teikyo University Chiba Medical Center, Chiba, Japan.Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, The University of Tokyo, Tokyo.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25759486

Citation

Mori, Jinichi, et al. "Fatal Adverse Drug Reactions of Anticancer Drugs Detected By All-case Post-marketing Surveillance in Japan." Japanese Journal of Clinical Oncology, vol. 45, no. 6, 2015, pp. 588-94.
Mori J, Tanimoto T, Miura Y, et al. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan. Jpn J Clin Oncol. 2015;45(6):588-94.
Mori, J., Tanimoto, T., Miura, Y., & Kami, M. (2015). Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan. Japanese Journal of Clinical Oncology, 45(6), 588-94. https://doi.org/10.1093/jjco/hyv030
Mori J, et al. Fatal Adverse Drug Reactions of Anticancer Drugs Detected By All-case Post-marketing Surveillance in Japan. Jpn J Clin Oncol. 2015;45(6):588-94. PubMed PMID: 25759486.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan. AU - Mori,Jinichi, AU - Tanimoto,Tetsuya, AU - Miura,Yuji, AU - Kami,Masahiro, Y1 - 2015/03/10/ PY - 2014/10/31/received PY - 2015/02/15/accepted PY - 2015/3/12/entrez PY - 2015/3/12/pubmed PY - 2015/8/25/medline KW - adverse drug reaction reporting systems KW - antineoplastic agents KW - post-marketing drug surveillance SP - 588 EP - 94 JF - Japanese journal of clinical oncology JO - Jpn. J. Clin. Oncol. VL - 45 IS - 6 N2 - OBJECTIVE: All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. METHODS: We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. RESULTS: Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. CONCLUSION: All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. SN - 1465-3621 UR - https://www.unboundmedicine.com/medline/citation/25759486/Fatal_adverse_drug_reactions_of_anticancer_drugs_detected_by_all_case_post_marketing_surveillance_in_Japan_ L2 - https://academic.oup.com/jjco/article-lookup/doi/10.1093/jjco/hyv030 DB - PRIME DP - Unbound Medicine ER -