Drug-induced hallucination: a case/non case study in the french pharmacovigilance database

ABSTRACT

Background and Objectives: Hallucinations are sensory perceptions which occur without external stimuli. There are associated with psychiatric disease but also can be related to organic disease and drug or toxic exposure. The purpose of our study was to investigate the association between exposure to medications and the reporting of hallucinations using data from the spontaneous-reporting French Pharmacovigilance Database (FPVD). Methods: We used the case/noncase method in the FPVD. Cases were all the observations of hallucination with the LLT term "perception disturbances", registered into the FPVD from January 1985 to Jan 2013. Data were expressed as odds ratio (OR) with their 95% confidence intervals. Results: Among the 469,181 reports of adverse effects recorded between 1985 and 2013, 4, 086 are hallucinations. For about 50% of these hallucinations were experimented by patient older than 65 years old. A statistically significant OR was found with several medications included rasagiline (OR 17.6 [ 95% CI 10.4-29.8] zolpidem (OR 12.9 [95% CI 11.3 - 14.8]), methylphenidate (OR 9.3 [95% CI 5.9-14.6]) and baclofene (OR 5.4 [95% CI 3.7-7.8]). An increased risk of hallucinations was also observing with non central nervous system drugs, including ertapenem (OR 24.0 [95% CI 14.2-40.5]), voriconazole (OR 12.9 [95% CI 10.2-16.5] and valacyclovir (OR 9.1 [95% CI 6.9-11.9]). Conclusions: This pharmacoepidermiological study describes and association between drugs and hallucinations. This relationship involves not only some already suspected drugs but also other drugs less known to induce such an adverse reaction. Despite the mandatory limits of this kind of study, these data should lead to special precautions in patient at risk (AU)

RESUMEN

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