FDA Drug Safety Communication

FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use 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. 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.

The information regarding warnings for fluoroquinolones and adverse effects on tendons applies to fluoroquinolones for systemic use (eg, tablets, capsules and injectable formulations); it does not apply to fluoroquinolones for ophthalmic or otic use (eg, eye drops and ear drops). Examples of systemic fluoroquinolones include the following:

Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)

Ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR)

Gemifloxacin (marketed as Factive)

Levofloxacin (marketed as Levaquin)

Moxifloxacin (marketed as Avelox)

Norfloxacin (marketed as Noroxin)

Ofloxacin (marketed as Floxin)

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov