In utero exposure to medications and congenital eye anomalies.

objectiveThe purpose of this study was to describe reports of congenital eye anomalies entered in the international pharmacovigilance database, with a particular focus on medications associated with this type of anomaly. METHODS AND ANALYSIS: This descriptive, retrospective study selected reports using the adverse reaction term 'congenital eye disorders' and included only those instances where at least one medication was documented as being administered via the transplacental route. Statistical analyses were performed using R software.

resultsWe extracted 2923 reports of eye anomalies in children exposed to medications in utero and ultimately selected 676 of these. Congenital anomalies of the eyelids (17.3%), lacrimal apparatus (9.4%) and orbit (1.1%) were the most common. The suspect medications highlighted in this study include teratogenic agents known to pose a risk of triggering eye anomalies such as valproic acid and mycophenolic acid. The list also includes medications with little or no reference in the literature to potential eye anomalies following in utero exposure, such as hydroxychloroquine and ondansetron.

conclusionThis study provides new data on in utero exposure to medications and congenital eye anomalies that can be severely debilitating. This is a descriptive study, with all the inherent limitations of the pharmacovigilance databases which are used for signal detection. This descriptive study does not allow us to conclude that there is a causal link between exposure to a given medication during pregnancy and congenital eye anomalies and is a basis for future studies using different data sources and/or other methods.