4
Joint Meeting of the Anti-Infective Drugs Advisory Committee and the
Drug Safety and Risk Management Committee Meeting
December 14 & 15, 2006
Vision Disorders
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Known, labeled events at time of approval
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Most commonly reported post-marketing
events since approval in Europe and
South America
During the pre-approval medical review, it was noted that these were the most commonly …
Blurred vision, unspecified visual disturbance, accommodation disorder, diplopia, and reduced visual acuity accounted for 96% of the visual adverse event reports