Ocular side effects possibly associated with isotretinoin usage

PURPOSE: To evaluate reported ocular side effects associated with isotretin oin usage. METHODS: One thousand seven hundred forty-one case reports received from sp ontaneous reporting systems, data from the Drug Safety Section of Roche Pha rmaceuticals, and the world's literature were evaluated using the World Hea lth Organization Causality Assessment Guide of Suspected Adverse Reactions. RESULTS: Thirty,eight different signs or symptoms of ocular abnormalities a ssociated with isotretinoin usage have been classified as "certain," "proba ble/likely," "possible," "unlikely," or "conditional/unclassifiable." CONCLUSION: Adverse ocular side effects secondary to isotretinoin that are "certain" include abnormal meibomian gland secretion, blepharoconjunctiviti s, corneal opacities, decreased dark adaptation, decreased tolerance to con tact lens, decreased vision, increased tear osmolarity, keratitis, meibomia n gland atrophy, myopia, ocular discomfort, ocular sicca, photophobia, and teratogenic ocular abnormalities. Those that are "probable/likely" are decr eased color vision (reversible) and permanent loss of dark adaptation. Thos e that have a "possible" association include permanent keratoconjunctivitis sicca. Suggested guidelines for ocular examination for patients on isotret inoin are given. (Am J Ophthalmol 2001; 132:299-305. (C) 2001 by Elsevier S cience Inc. All rights reserved.).