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Quinolone antibiotic labeling to include warnings of potential tendon inflammation/rupture.

Executive Summary

QUINOLONE MANUFACTURERS AGREE TO TENDONITIS/RUPTURE WARNING IN LABELING following a year of negotiations with FDA. Letters from FDA requesting that labeling changes reflect the potential for fluoroquinolone antibiotics to cause tendonitis or tendon rupture were first sent to the five manufacturers in April 1995. Although several companies initially protested the change, according to FDA, all had submitted approved labeling changes by June.

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