Abstract

This retrospective case series describes the association between ocular hemorrhage and 3-hydroxy-3-methylglutaryl conenzyme A (HMG-CoA) reductase inhibitors (statins). The clinical characteristics of 95 case reports submitted to the World Health Organization (WHO), the Food and Drug Administration, and the National Registry of Drug-Induced Ocular Side Effects are summarized with classification of this ocular side effect according to WHO criteria. The average time to onset of ocular hemorrhage was 300 days with 11 positive dechallenge reports and 2 positive rechallenge cases. Some patients also received medications known to increase bleeding times. From the collected data, ocular hemorrhage is "possibly" due to statin therapy.

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