Drug related falls: a study in the French Pharmacovigilance database

OBJECTIVE: 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. METHODS: 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). RESULTS: 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]). CONCLUSION: 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.