Itraconazole Contaminated with Rilmazafone in Japan: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database
Tóm tắt
In early December 2020, the antifungal medication, itraconazole (ITCZ), was mistakenly contaminated with rilmazafone in Japan. Healthcare professionals reported adverse drug reaction reports associated with ITCZ and included central nervous system-depression symptoms such as dizziness, lightheadedness, loss of consciousness, and intense drowsiness. We examined ITCZ-associated suspicious cases using the Japanese Adverse Drug Event Report (JADER) database to determine the impact of adverse drug reaction reporting on post-marketing safety measures. Adverse drug reaction reports in which the suspicious or concomitant medication was ITCZ or fluconazole (FLCZ) were extracted from the JADER dataset. The number of adverse drug reaction reports associated with central nervous system-depression adverse drug reactions were counted, and chronological changes were compared with ITCZ and FLCZ. Of the 713,893 adverse drug reaction reports in the JADER database, 5048 cases were associated with ITCZ and 6007 cases with FLCZ. When ITCZ contamination occurred, the number of adverse drug reaction reports associated with ITCZ increased rapidly, while those with FLCZ did not. In addition, the proportion of central nervous system-depression adverse drug reactions increased only in the ITCZ-associated report. An incident of ITCZ contamination with rilmazafone was detected on the JADER retrospectively. This case highlights the importance of spontaneous adverse drug reaction reporting, even if the causal relationship between the drug and adverse drug reaction is unknown.
Tài liệu tham khảo
Yakuji Nippo, Limited. [Fukui Prefecture] Carried out on-site investigation of Kobayashi Kako: health problems expanded to 128 cases. https://www.yakuji.co.jp/entry83968.html. Accessed 16 Jan 2022.
Ministry of Health, Labour and Welfare. Japanese article. In: 8th Meeting of the Investigative Committee on Safety Measures for Medicinal Products. https://www.mhlw.go.jp/content/11125000/000704377.pdf. Accessed 16 Jan 2022.
Ministry of Health, Labour and Welfare. Japanese article. In: FY2020 3rd Pharmaceutical Safety Measures Subcommittee. https://www.mhlw.go.jp/content/11120000/000751984.pdf. Accessed 16 Jan 2022.
Tsuchiya M, Obara T, Sakai T, Nomura K, Takamura C, Mano N. Quality evaluation of the Japanese Adverse Drug Event Report database (JADER). Pharmacoepidemiol Drug Saf. 2020;29:173–81. https://doi.org/10.1002/pds.4944.
Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36:75–81. https://doi.org/10.1007/s40264-012-0014-6.
Wakao R, Lönnstedt IM, Aoki Y, Chandler RE. The use of subgroup disproportionality analyses to explore the sensitivity of a global database of individual case safety reports to known pharmacogenomic risk variants common in Japan. Drug Saf. 2021;44:681–97. https://doi.org/10.1007/s40264-021-01063-1.
Sakai T, Ohtsu F, Mori C, Tanabe K, Goto N. Signal of miscarriage with aripiprazole: a disproportionality analysis of the Japanese Adverse Drug Event Report database. Drug Saf. 2017;40:1141–6. https://doi.org/10.1007/s40264-017-0560-z.
Inman WHW, Gill EP. Monitoring for drug safety. 2nd ed. Lancaster: MTP Press; 1986.
Van Puijenbroek EP, van Grootheest K, Diemont WL, Leufkens HGM, Egberts ACG. Determinants of signal selection in a spontaneous reporting system for adverse drug reactions. Br J Clin Pharmacol. 2001;52:579–86. https://doi.org/10.1046/j.0306-5251.2001.01501.x.
Pottegård A, Kristensen KB, Ernst MT, Johansen NB, Quartarolo P, Hallas J. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. BMJ. 2018;362: k3851.
Noda A, Sakai T, Obara T, Miyazaki M, Tsuchiya M, Oyanagi G, et al. Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report database. BMC Pharmacol Toxicol. 2020;21(1):36.
Tsuchiya M, Obara T, Miyazaki M, Noda A, Takamura C, Mano N. The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade. Int J Clin Pharm. 2020;42:728–36. https://doi.org/10.1007/s11096-020-00969-7.