FDA requires boxed warning about tendinitis risk on
fluoroquinolones.
by Splete, Heidi
The Food and Drug Administration said that manufacturers of
fluoroquinolone drugs will be required to add a boxed warning to the
label and provide a medication guide for patients explaining the
increased risk of tendinitis and tendon rupture.
The current labeling includes information about the risk of
tendinitis and tendon rupture, but new adverse event reports suggest
that a stronger warning is needed.
"Despite the current warning information on tendon adverse
effects and tendon rupture in the product labeling for fluoroquinolones,
the FDA continues to receive a considerable number of reports about
tendon-related adverse events," said Dr. Edward Cox, director of
the office of antimicrobial products in the FDA's Center for Drug
Evaluation and Research (CDER).
The fluoroquinolone drugs that will carry the new labeling include
ciprofloxacin, ciprofloxacin extended release, gemifloxacin,
levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.
Most patients tolerate fluoroquinolones without complications, said
Dr. Renata Albercht, director of the division of special pathogen and
transplant products at CDER.
Tendinitis and tendon rupture can occur during treatment or in the
first several months after completion of the medication course. Other
factors that can further increase the risk of tendinitis or tendon
rupture when taking fluoroquinolones include concomitant corticosteroid
use; having undergone a lung, kidney, or heart transplant; and being
older than 60 years, Dr. Albrecht said. These factors will also be noted
on the labeling.
Patients who experience pain or swelling in a tendon should stop
taking the medication and contact their health care professionals
promptly, Dr. Albrecht emphasized.
"Patients should also avoid exercising or using the affected
area at the first sign of pain, swelling, or inflammation," she
said. Although tendon ruptures have been reported without warning in
patients taking fluoroquinolones, most ruptures occur after 7-14 days of
symptoms such as pain, stiffness, and inflammation, based on the
FDA's adverse event reporting data.
To report any adverse events associated with fluoroquinolones,
contact the FDA MedWatch program by calling 800-332-1088.
BY HEIDI SPLETE
Senior Writer
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