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Supplemental Boxed Warnings and Medication Guides Added to Fluoroquinolone Drugs
Source: The Food and Drug Administration Fluoroquinolones, drugs used to treat bacterial infections in many parts of the body, are getting supplemental Boxed Warnings added to the current prescribing information due to an increased risk of tendonitis and tendon rupture. Medication guides for patients are also being developed. The risks for tendonitis and tendon rupture are further increased for persons over the age of 60; in kidney, heart and lung transplant recipients; and for persons using concomitant steroid therapy. Patients should be advised to contact their doctor immediately at the first sign of tendon pain, swelling or inflammation. In addition, patients should avoid exercise and use of the infected area. Non-fluoroquinolone medications may be prescribed by the physician if needed as an alternative treatment. Common examples of fluoroquinolones include:
Special Note: Information regarding warnings for fluoroquinolones and adverse effects on tendons applies only when using systemically (i.e. tablets, capsules and injections). These warnings do not apply when fluoroquinolones are used for ophthalmic or otic use (i.e., eye drops and ear drops). Read the entire 2008 MedWatch Safety Summary, including a link to the 'Information for Healthcare Professionals' page, at: Additional information for Physicians can be found at: |
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