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Scientific challenges in postmarketing surveillance of ocular adverse drug reactions.

Fraunfelder FW, Fraunfelder FT

Casey Eye Institute, Oregon Health and Science University, 3375 SW Terwilliger Blvd., Portland, OR 97239, USA. eyedrug@ohsu.edu

PURPOSE: To highlight the challenges of postmarketing surveillance for drug-related adverse events in the practice of ophthalmology. DESIGN: A retrospective review of the medical literature and postmarketing surveillance databases. METHODS: MEDLINE literature review of sildenafil-associated or amiodarone-associated optic neuropathy and chloramphenicol-associated blood dyscrasias. RESULTS: Sildenafil, amiodarone, and chloramphenicol may all cause adverse ocular events; however, the data are not conclusive. CONCLUSIONS: Reports in peer-reviewed medical journals may be proven incorrect over time. For drug-induced adverse ocular events, there is little true science after the drug reaches the marketplace, so the percentage of incorrect conclusions may be high. Clinicians should be wary of reports of adverse ocular effects until data are confirmed by multiple authors over the long-term. Even so, spontaneous reports from postmarketing surveillance databases may be the first and only signal of an adverse ocular event.

Published 25 December 2006 in Am J Ophthalmol, 143(1): 145-149.
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