Several publications indicate that the female gender experiences a higher incidence of adverse drug reactions (ADRs) than does the male gender. The reasons, however, remain unclear. Gender-specific differences in the pharmacokinetic and pharmacodynamic behaviour of drugs could not be identified as an explanation. The aim of this study was to analyse ADR risk with respect to gender, age and number of prescribed drugs.
A prospective multicenter study based on intensive pharmacovigilance was conducted. Information on patient characteristics and evaluated ADRs was stored in a pharmacovigilance database—KLASSE.
In 2,371 patients (1,012 female subjects), 25,532 drugs were prescribed. In 782 patients, at least one ADR was found. A multivariate regression analysis adjusting for age, body mass index (BMI) and number of prescribed drugs showed a significant influence of female gender on the risk of encountering ADRs [odds ratio (OR) 1.596, confidence interval (CI) 1.31–1.94; p < 0.0001). Dose-related ADRs (51.8%) were the dominant type in female subjects. Comparing system organ classes of the World Health Organisation (SOC-WHO), cardiovascular (CV) ADRs were particularly frequent in female subjects (OR 1.92, CI 1.15–3.19; p = 0.012).
Our data confirm the higher risk of ADRs among female subjects compared with a male cohort. Several explanations were investigated. No single risk factor could be identified.
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We thank Ulrich Rothe (head of pharmacy at the University of Regensburg) and Prof. Dr. Jürgen Schölmerich (director of the Medical Department I) of the University Hospital of Regensburg for the possibility of implementing KLASSE in their departments to establish computerised intensive drug surveillance studies. We also thank Prof. Micha Levy, the former incumbent of the Wilfred P. and Rose J. Cohen chair in Internal Medicine and the former Chairman of Medicine at Hadassah-Hebrew University School of Medicine for his cooperation in developing KLASSE and the early discussions on this topic and his comments. Furthermore, we thank Prof. Petra Thürmann (director of the Helios Research Center, director of the Philipp Klee Institute for Clinical Pharmacology, member of the German Drug Commission) for discussions and important comments. Finally, we thank our physicians and pharmacists who participated in intensive pharmacovigilance, namely, M. Reisig, PhD, M. Finkenzeller, PhD, S. Krebs, PhD and for medical informatics A. Ackermann, PhD and M. Criegee-Rieck, PhD, for developing and implementing KLASSE in clinical routine.
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Zopf, Y., Rabe, C., Neubert, A. et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol 64, 999 (2008). https://doi.org/10.1007/s00228-008-0494-6
- Risk factors
- Adverse drug reaction