FDA ALERT [7/8/2008]: FDA is notifying the makers of
fluoroquinolone antimicrobial drugs for systemic use of the need to add
a boxed warning to the prescribing information about the increased risk
of developing tendinitis and tendon rupture in patients taking
fluoroquinolones and to develop a Medication Guide for patients. The
addition of a boxed warning and a Medication Guide would strengthen the
existing warning information already included in the prescribing
information for fluoroquinolone drugs.
Fluoroquinolones are associated with an increased risk of
tendinitis and tendon rupture. This risk is further increased in those
over age 60, in kidney, heart, and lung transplant recipients, and with
use of concomitant steroid therapy. Physicians should advise patients,
at the first sign of tendon pain, swelling, or inflammation, to stop
taking the fluoroquinolone, to avoid exercise and use of the affected
area, and to promptly contact their doctor about changing to a
non-fluoroquinolone antimicrobial drug.
Selection of a fluoroquinolone for the treatment or
prevention of an infection should be limited to those conditions that
are proven or strongly suspected to be caused by bacteria.
This information reflects FDA's current analysis of data
available to FDA concerning fluoroquinolone antimicrobials. FDA intends
to update this sheet when additional information or analyses become
available.
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Healthcare Professional Information
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Fluoroquinolone Antimicrobial Drugs
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Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
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Ciprofloxacin extended release (marketed as Cipro XR and Proquin XR)
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Gemifloxacin (marketed as Factive)
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Levofloxacin (marketed as Levaquin)
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Moxifloxacin (marketed as Avelox)
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Norfloxacin (marketed as Noroxin)
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Ofloxacin (marketed as Floxin and generic ofloxacin)
