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Women encounter ADRs more often than do men
1Department of Medicine 1, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany. yurdaguel.zopf@uk-erlangen.de
European Journal of Clinical Pharmacology
|July 8, 2008
Summary
Women face a higher risk of adverse drug reactions (ADRs) compared to men. This study analyzed gender, age, and drug interactions, finding female gender significantly increases ADR risk, particularly for dose-related and cardiovascular events.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Drug Safety
Background:
- Existing literature suggests higher adverse drug reaction (ADR) incidence in females, but underlying reasons are unclear.
- Pharmacokinetic and pharmacodynamic differences do not fully explain gender-based variations in ADRs.
Purpose of the Study:
- To investigate the influence of gender, age, and the number of prescribed drugs on the risk of experiencing ADRs.
- To identify specific factors contributing to increased ADR risk in female patients.
Main Methods:
- A prospective, multicenter study utilizing intensive pharmacovigilance.
- Data collected on patient characteristics and evaluated ADRs were stored in the KLASSE pharmacovigilance database.
Main Results:
- Analysis of 2,371 patients revealed a significant association between female gender and increased ADR risk (OR 1.596, p < 0.0001), even after adjusting for age, BMI, and drug count.
- Dose-related ADRs were more prevalent in females (51.8%).
- Cardiovascular ADRs were significantly more frequent in female subjects (OR 1.92, p = 0.012).
Conclusions:
- The study confirms a higher risk of ADRs in female patients compared to males.
- Despite investigation, no single definitive risk factor was identified to explain this gender disparity.
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