Signalling possible drug-drug interactions in a spontaneous reporting system: delay of withdrawal bleeding during concomitant use of oral contraceptives and itraconazole

被引:101
作者
van Puijenbroek, EP
Egberts, ACG
Meyboom, RHB
Leufkens, HGM
机构
[1] LAREB, Netherlands Pharmacovigilance Fdn, NL-5237 MH Shertogenbosch, Netherlands
[2] Utrecht Inst Pharmaceut Sci, Dept Pharmacoepidemiol & Pharmacotherapy, Utrecht, Netherlands
[3] Hosp Pharm Midden Brabant, Tilburg, Netherlands
关键词
drug interactions; itraconazole; oral contraceptives; pharmacovigilance; signal detection; withdrawal bleeding;
D O I
10.1046/j.1365-2125.1999.00957.x
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Aims In spontaneous adverse drug reaction reporting systems, there is a growing need for methods facilitating the automated detection of signals concerning possible adverse drug reactions. In addition, special attention is needed for the detection of adverse drug reactions resulting from possible drug-drug interactions. We describe a method for detecting possible drug-drug interactions using logistic regression analysis to calculate ADR reporting odds ratios. Methods To illustrate this method, we analysed the adverse drug reaction 'delayed withdrawal bleeding' resulting from a possible interaction between itraconazole and oral contraceptives in reports received by the Netherlands Pharmacovigilance Foundation LAREB between 1991 and 1998. Results In total 5,503 reports were included in the study. The odds ratio, adjusted for year of reporting, age and source of the reports, for a delayed withdrawal bleeding in women who used both drugs concomitantly compared with women who used neither oral contraceptives, nor itraconazole, was 85 (95% CI: 32-230). Conclusions Since spontaneous reporting systems can only generate signals concerning possible relationships, this association needs to be analysed by other methods in more detail in order to determine the real strength of the relationship. This approach might be a promising tool for the development of procedures for automated detection of possible drug-drug interactions in spontaneous reporting systems.
引用
收藏
页码:689 / 693
页数:5
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