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Health Agencies Update
August 27, 2008

Fluoroquinolone Warning

JAMA. 2008;300(8):891. doi:10.1001/jama.300.8.891-b

The Food and Drug Administration (FDA) is requiring labeling for fluoroquinolone antibiotics to include a black box warning that patients taking these drugs are at increased risk of tendinitis and tendon rupture.

Despite an existing warning that fluoroquinolones may increase the risk of tendon rupture, a recent FDA analysis revealed that the agency continues to receive many reports of tendon-related adverse events among patients taking these drugs. In addition to the black box warning, the manufacturers of fluoroquinolones are being required to provide medication guides outlining the risk.