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Merck Trusopt

Executive Summary

Merck's reporting of ocular side effects for dorzolamide ophthalmic solution are questioned in FDA letter to company Aug. 20. "Merck claims that the incidence of stinging reported with the use of Trusopt is 11.6%. In the Data Available Package, Merck claims that the most common ocular experience with the use of MK-507 (Trusopt) were burning/stinging at 3.5%," the letter states. "However, these claims are inconsistent with the approved product labeling that states 'in clinical studies, the most frequent adverse events associated with Trusopt were ocular burning, stinging, or discomfort'" in one-third of patients. Product labeling "does not distinguish between the ocular discomfort symptoms"
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PS032751

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