53% were older than 65 years old and 9 % were children of less than 15 years. 4086 patients experimented hallucinations. The 95% confidence intervals (CI) were calculated using the Woolf method 11.Ĥ69,181 reports of ADRs had been recorded in the FPVD from 1985 to 1 January 2013. The odds ratio (OR) is the ratio of reporting of one specific event versus all other events for a given drug compound 10. Cases were defined as reports corresponding to hallucination from the LLT terms "perception disturbances", and non-cases as all other reported ADRs for the same period. The case/non-case method was used to measure disproportionality of the combination between a drug and a particular ADR in the FPVD. Observations reported with hallucination from 1985 to were reviewed. Reports are reviewed and analyzed by medically qualified personnel before being entered into the FPVD.ĪDR were coded according to the Medical Dictionary for Regulatory Activities (MedDRA ®) 9. This database was established in 1985 8 to register all adverse drug reactions (ADR) reported by health professionals or patients to the French Pharmacovigilance System. The study used data from the French Pharmacovigilance Database (FPVD) of all adverse reactions occurring with commercially approved drugs in France. In this context, the aim of this study was to investigate the association between exposure to medications and hallucinations. They may be symptomatic of cerebral disease, functional psychoses and can also be induced or worsened by drugs 7. The percentage of "normal" subjects reporting hallucinatory experiences is substantial 5,6. It is a relatively common symptom, with a prevalence of 4 to 38% 4. Hallucination is now defined by the Diagnostic and Statistical Manual of Mental Disorders DSMV as "a sensory perception that has the compelling sense of reality of a true perception but that occurs without external stimulation of the relevant sensory organ" 3. "A person is said to labor under a hallucination, or to be a visionary, who has a thorough conviction of the perception of a sensation, when no external object, suited to excite this sensation, has impressed the senses" 1,2. In 1837 the French alienist Esquirol defined hallucinations as follows. Key words: Hallucination Drug-induced Psychotic disorder. Despite the mandatory limits of this kind of study, these data should lead to special precautions in patient at risk. This relationship involves not only some already suspected drugs but also other drugs less known to induce such an adverse reaction. An increased risk of hallucinations was also observed with non central nervous system drugs, including ertapenem (OR 24.0 ), voriconazole (OR 12.9) and valacyclovir (OR 9.1 ).Ĭonclusions: This pharmacoepidemiological study describes an association between drugs and hallucinations. For about 50% of these hallucinations were experimented by patient older than 65 years old.Ī statistically significant OR was found with several medications included rasagiline (OR 17.6 ), zolpidem (OR 12.9 ), methylphenidate (OR 9.3 ) and baclofene (OR 5.4 ). Results: Among the 469,181 reports of adverse effects recorded between 19, 4,086 are hallucinations. Data were expressed as odds ratio (OR) with their 95% confidence intervals. Cases were all the observations of hallucination with the LLT term “perception disturbances”, registered into the FPVD from January 1985 to Jan 2013. Methods: We used the case/noncase method in the FPVD. 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). There are associated with psychiatric disease but also can be related to organic disease and drug or toxic exposure. Franceīackground and Objectives: Hallucinations are sensory perceptions which occur without external stimuli. ** Department Pediatrics, Pulmonology and Allergy Service, Necker-Enfants Malades Hospital, Paris. * Regional Center for Pharmacovigilance and Pharmacoepidemiology, Reims University Hospitals, Reims. Malak Abou Taam* Paul de Boissieu* Rola Abou Taam** Alexandre Breton* and Thierry Trenque* Drug-induced hallucination: A case/non case study in the French Pharmacovigilance Database
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