FDA Mandates New Boxed Warning for Fluoroquinolones

The FDA announced last month it was requiring manufacturers of systemic fluoroquinolones to place a boxed warning on these products' package labels concerning the increased risk of tendonitis and tendon rupture associated with use of these drugs. FDA officials also have called for fluoroquinolone manufacturers to create a Medication Guide for patients that discusses these and other potential side effects.

According to one FP expert, family physicians and other primary care health professionals should take note of the FDA's action, because these broad-spectrum antibiotics are used for many indications.

"Fluoroquinolones are in common use for older patients for urinary tract infections and for COPD (chronic obstructive pulmonary disease) exacerbations," said Jonathan Temte, M.D., Ph.D., of Madison, Wis. An associate professor at the University of Wisconsin School of Medicine and Public Health in Madison, Temte is an infectious disease researcher and a member of the CDC's Advisory Committee on Immunization Practices.

"Whereas their use may not be first-line, they are used extensively in the primary care arena," he added.

In an FDA alert sent to health care professionals, agency officials noted that the risk of these tendon problems is even greater in people who are older than 60, patients who are taking steroids, and those who have had a lung, kidney or heart transplant.

"Health care professionals should consider the potential benefit and risks to each individual patient before prescribing a fluoroquinolone antimicrobial," the FDA alert noted. "While most patients prescribed fluoroquinolones tolerate these medicines, rarely, patients develop serious adverse reactions, which may include convulsions, hallucinations, depression, QTc prolongation and torsades de pointes, or Clostridium difficile-associated diarrhea.

"Rarely, damage to the liver, kidneys or bone marrow, or alterations in glucose homeostasis may occur."

According to the FDA, patients taking fluoroquinolones should be advised to discontinue the drug right away if they experience pain or inflammation in a tendon area. They also should avoid exercise and use of the affected area and consult their physician promptly about possibly switching to a non-fluoroquinolone antimicrobial.

Medications included in this class of drugs are 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; and ofloxacin, marketed as Floxin and generic ofloxacin.

The FDA action applies only to systemic fluoroquinolones; topical formulations, such as ophthalmic or otic drops, are not affected.

Physicians can contact MedWatch, the FDA's Safety Information and Adverse Event Reporting Program, to report any serious adverse events associated with the use of fluoroquinolones or other drugs, dietary supplements, biologic agents or medical devices.