ROCKVILLE, Maryland—The FDA will require a “black box” warning about tendonitis and tendon ruptures associated with fluoroquinolone antibiotics. This drug class includes ciprofloxacin and related antibiotics.

"Fluoroquinolones are effective in treating certain bacterial infections, but healthcare professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendonitis and tendon rupture, particularly for certain patient populations," said Edward Cox, MD, director of the office of antimicrobial products at the FDA's Center for Drug Evaluation and Research in Rockville, Md. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."
"Fluoroquinolones are effective in treating certain bacterial infections, but healthcare professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendonitis and tendon rupture, particularly for certain patient populations."?Edward Cox, MD

Increased risk cited for certain populations

The risk of tendonitis and tendon rupture is further increased in those individuals taking fluoroquinolones who are aged ≥60; are kidney, heart, and lung transplant recipients; and/or are taking concomitant steroids. The FDA is also asking doctors to advise their patients that if they have any sign of tendon pain and swelling or inflammation, they should stop taking the drugs immediately; patients also should avoid exercising the affected area and contact their doctor immediately.

These warnings would apply to fluoroquinolones for systemic use including Cipro (ciprofloxacin), Cipro XR, Proquin XR, Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin (ofloxacin). The warnings would not apply to fluoroquinolones for topical, ophthalmic, or optic use.

Warning no surprise to rheumatologists

"We've seen quite a number of these cases in the past several years," said Eric Matteson, MD, professor of medicine at the Mayo Clinic in Rochester, Minn. "The relationship between use of fluoroquinolones and the development of tendonitis, including Achilles tendonitis, has been recognized for the past 25 years, [however,] this complication which may result in rupture of the tendon is uncommon."

Although there are known risk factors for developing tendonitis while on fluoroquinolones, "it is unclear if patients with various forms of arthritis, including rheumatoid arthritis, are at particular risk," Dr. Matteson said. "These conditions do not contraindicate the use of fluoroquinolones, but physicians should consider cautioning their patients about this possible complication, and rheumatologists should enquire about fluoroquinolones use in patients presenting with new onset tendonitis."
 
Reference
1. FDA requests boxed warnings on fluoroquinolones antimicrobial drugs. [press release July 8, 2008]. FDA Website. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html.