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FDA Strengthens Fluoroquinolone Tendon Warnings
By Michael Smith , North American Correspondent, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor
Edward Cox, M.D.
FDA, Center for Drug Evaluation and Research
ROCKVILLE, Md., July 8 -- The FDA announced today it will require a boxed warning about the risks of tendinitis and tendon rupture on the labels of fluoroquinolone antibiotics, heightening attention to an existing caution.
The agency is also requiring drug makers to provide a medication guide to patients about possible side effects, according to Edward Cox, M.D., of the FDA's Center for Drug Evaluation and Research. The FDA did not require a letter to healthcare professionals, Dr. Cox added.
"This risk of tendinitis and tendon rupture is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy," said the FDA.
"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."
The move followed a lawsuit filed earlier this year by the lobby group, Public Citizen Health Research Group, which said it was trying to force the FDA to respond to a petition it filed in 2006 seeking stronger warnings.
Public Citizen said its review of the adverse event database showed 262 reported cases of tendon ruptures, 258 cases of tendinitis, and 274 cases of other tendon disorders from November 1997 through Dec. 31, 2005.
For several years, Dr. Cox and other FDA officials said in a telephone press conference, the labeling for the drugs has carried information about the increased risk, which is about three to four times the rate in the general population.
The new language will "strengthen the warning," Dr. Cox said, adding he could not comment on the Public Citizen lawsuit.
The move also came after the FDA conducted its own analysis of medical literature and post-marketing adverse event reports, according to the agency's Renata Albrecht, M.D.
Ann McMahon, M.D., of the FDA's office of surveillance and epidemiology, said there have been "several hundred" reported cases of tendon rupture, but would not be more precise.
The drugs involved are ciprofloxacin (Cipro, Cipro XR, and Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin), as well as generic versions where available.
North American Correspondent
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North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers' Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.
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