All authors on behalf of the French Network of Pharmacovigilance Centres.
Article first published online: 26 OCT 2004
Copyright © 2004 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 14, Issue 1, pages 11–16, January 2005
How to Cite
Souchet, E., Lapeyre-Mestre, M. and Montastruc, J.-L. (2005), Drug related falls: a study in the French Pharmacovigilance database. Pharmacoepidem. Drug Safe., 14: 11–16. doi: 10.1002/pds.1038
No conflict of interest was declared.
- Issue published online: 13 DEC 2004
- Article first published online: 26 OCT 2004
- Manuscript Accepted: 1 SEP 2004
- Manuscript Revised: 29 JUN 2004
- Manuscript Received: 10 DEC 2003
- psychotropic drugs;
- imipraminic antidepressants;
- serotonin reuptake inhibitors;
To investigate the risk of falls associated with drugs among the French population using data reported to the French spontaneous reporting system and recorded in the French Pharmacovigilance database.
All cases including a fall were searched in the French Pharmacovigilance database between 1995 and 1999. Drugs involved and characteristics of patients were investigated. In a second step, we estimated the risk associated with psychotropic and cardiovascular drugs in a case/non case comparison, where cases were reports including a fall and non cases all other reports. This risk was estimated by calculation of crude and age and gender adjusted reporting odds ratios (ROR).
During this period, 328 reports including a fall were reported (0.4% of the database). Patients were female in 70%. Mean age was 76 ± 18 years. Comparisons between cases and non cases showed that cases were more likely to be women (OR: 1.9; 95% confidence interval (CI) [1.5–2.4]) and older. After adjustment on age and gender, falls remained significantly associated with exposure to benzodiazepines (4.7 [3.7–5.9]), imipraminic antidepressants (3.6 [2.5–5.1]), serotonin reuptake inhibitor (SRI) antidepressants (2.2 [1.5–3.1]) or nitrates (1.9 [1.2–2.8]).
This study confirms that taking psychotropic drugs strongly increases the risk of falls. The role of cardiovascular drugs (except nitrates) remains not significant when confounding factors are taken into account. According to the very high prevalence of psychotropic drug use in the French elderly, further study are needed to investigate the relative effect of some drugs on falls, like for example SRIs or short acting benzodiazepines. Copyright © 2004 John Wiley & Sons, Ltd.