Adverse Event Signals of Interstitial Lung Disease in the FDA Adverse Event Reporting System (FAERS) Database and the Japanese Adverse Drug Event Report (JADER) Database

DOI 1 Citations
  • Matsui Toshinobu
    Laboratory of Drug Informatics, Gifu Pharmaceutical University
  • Umetsu Ryogo
    Laboratory of Drug Informatics, Gifu Pharmaceutical University
  • Kato Yamato
    Laboratory of Drug Informatics, Gifu Pharmaceutical University
  • Ueda Natsumi
    Laboratory of Drug Informatics, Gifu Pharmaceutical University
  • Abe Junko
    Laboratory of Drug Informatics, Gifu Pharmaceutical University Medical Database Co., LTD
  • Nakayama Yoko
    Laboratory of Drug Informatics, Gifu Pharmaceutical University
  • Hane Yuuki
    Laboratory of Drug Informatics, Gifu Pharmaceutical University
  • Kinosada Yasutomi
    United Graduate School Drug Discovery and Medical Information Sciences, Gifu University
  • Nakamura Mitsuhiro
    Laboratory of Drug Informatics, Gifu Pharmaceutical University

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Other Title
  • FAERSおよびJADERを用いた間質性肺炎に関する 医薬品のシグナル検出

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The Japanese Ministry of Health, Labor, and Welfare lists interstitial lung disease as an serious adverse drug event.  The Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases are available to detect adverse events signals.  We analyzed reports of interstitial lung disease in FAERS and JADER and calculated the reporting fraction and reporting odds ratio (ROR) of drugs potentially associated with interstitial lung disease.  We applied Weibull shape parameter to time-to-event data in JADER.  We found FAERS to contain 3,522,995 reports from January 2004 to March 2013 and JADER to contain 292,720 reports from April 2004 to November 2013.  In FAERS, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 7.4% (285/3,856 reports), 3.2% (86/2,663 reports), and 1.9% (357/18,366 reports), and RORs (95% confidence interval [CI]) were 29.26 (25.89-33.07), 11.99 (9.66-14.88), and 7.29 (6.55-8.11), respectively.  In JADER, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 45.6% (1,070/2,348 reports), 22.1% (77/348 reports), and 27.9% (468/1,678 reports), and RORs (95% CI) were 18.46 (16.99-20.06), 5.83 (4.52-7.51), and 8.14 (7.31-9.07), respectively.  Adverse event signals of interstitial lung disease were observed in most drugs, which are warned as a suspected drug in the literature.  With the time-to-event analysis using Weibull shape parameter, time-dependency of adverse events in each drug was different.  Therefore, these drugs should be used carefully in clinical practice.

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