Actual status of adverse reactions to antimicrobials covered/not covered by a public relief system

Saki Sato, Kazuaki Matsumoto, Yuko Kuroda, Junko Kizu

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The Adverse Drug Reaction Relief System is a public relief system for those suffering from serious injuries related to drugs despite their appropriate use, and information regarding the payment of relief benefits as part of it is published on the Pharmaceuticals and Medical Devices Agency's website. To clarify the actual states of adverse reactions to antimicrobials, this study examined adverse events related to them as responsible drugs, which had been covered by this system. Data such as the course of injury and symptoms, contained in reports which had been submitted within the period between April 2004 and March 2014, were collated and analyzed based on the type of antimicrobial. Among the 9,845 claims for the payment of relief benefits, 2,067 were related to antimicrobials, 1,940 and 157 of which had been covered and not covered by the relief system, respectively; among the latter, 61 had not been covered for the reason that "the purpose or method of drug use could not be regarded as appropriate". The number of major injuries involving each organ system was as follows: skin and subcutaneous tissue disorders: 1,010; hepatobiliary system disorders: 429; and immune system disorders: 312. The course of injury was: death: 225; disability: 79; and alleviation: 1,636. The majority of deaths and disabilities were associated with toxic epidermal necrosis, Stevens-Johnson syndrome, or anaphylactic shock. Furthermore, the most frequent causes of death after a single administration of antimicrobials covered by the relief system were immune system disorders (anaphylactic shock), as observed in 43. Anaphylactic shock had occurred after the administration of: cephems: 15; beta-lactamase inhibitors: 16; carbapenems: 6; glycopeptides: 2; fosfomycin: 2; penicillins: 1; or macrolides: 1. Considering that antimicrobial use had been inappropriate in some cases, the further promotion of the appropriate use of these drugs, in addition to interviews prior to their use, explanations of initial symptoms to patients, and information regarding necessary items, such as appropriate measures against such symptoms, may be important.

Original languageEnglish
Pages (from-to)656-662
Number of pages7
JournalJapanese Journal of Chemotherapy
Issue number4
Publication statusPublished - 2016 Jul


  • Adverse drug reaction
  • Adverse event
  • Antimicrobial drug

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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