title: [Drugs and retinal disorders: A case/non-case study in the French pharmacovigilance database].
abstract: Retina is the part of the eye suffering most damage from pharmaceutical molecules. Drug-induced retinopathies have been described but data are scarce and sometimes conflicting especially concerning its potential seriousness. The aim of this study was to investigate potential associations between drugs and retinal disorders using the French Pharmacovigilance data. We used the case/non-case method in the French PharmacoVigilance Database (FPVD) to identify drugs able to induce retinopathies. Cases were reports of retinal disorders in the FPVD between January 2008 and December 2012. Non-cases were all other reports during the same period. To assess the association between retinopathy and drug intake, we calculated the odds-ratio (OR) [with their 95% confidence intervals] for all drugs associated with at least 3 cases of retinopathy. Among the 123 687 adverse drug reactions recorded during the studied period, we identified 164 cases of retinal disorders. Significant associations were found for 11 drugs. The main therapeutic classes were antirhumatismals (hydroxychloroquine, chloroquine and etanercept: 18 cases), anti-infective (ribavirine, PEG-interferon-alfa-2a and cefuroxime: 16 cases) and antineoplastic drugs (imatinib and letrozole: 8 cases. Three other drugs were also found: raloxifene (5 cases), erythropoietin beta (4 cases) and ranibizumab (3 cases). Taking into account the limits of the methodology, our study confirmed the association between retinopathy and some expected drugs such as aminoquinolines, interferons, imatinib or ranibizumab. Other drugs like erythropoietin beta, cefuroxime, letrozole and etanercept were significantly associated with retinal disorders although this was not or poorly described in the literature. Thus, further prospective studies are necessary to confirm such associations.
authors.affiliation: Service de pharmacologie clinique, centre régional de pharmacovigilance et de renseignement sur les médicaments, CHU de Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Bourgeois
authors.affiliation: Service de pharmacologie clinique, centre régional de pharmacovigilance et de renseignement sur les médicaments, CHU de Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France. Electronic address: francois.chavant@chu-poitiers.fr.
authors.forename: François
authors.initials: F
authors.lastname: Chavant
authors.affiliation: Service de pharmacologie clinique, centre régional de pharmacovigilance et de renseignement sur les médicaments, CHU de Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Lafay-Chebassier
authors.affiliation: Service d'ophtalmologie, CHU de Poitiers, 86021 Poitiers, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Leveziel
authors.affiliation: Service de pharmacologie clinique, centre régional de pharmacovigilance et de renseignement sur les médicaments, CHU de Poitiers, 2, rue de la Milétrie, 86021 Poitiers, France.
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Pérault-Pochat
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D011446:Prospective Studies; D012164:Retinal Diseases / Q000139:chemically induced* / Q000453:epidemiology*; D055815:Young Adult
keywords: Adverse drug reaction; Atteintes rétiniennes; Case/non-case study; Drug; Effet indésirable; Médicament; Retinal disorders; Étude cas/non cas