| Jan Drew 2006-08-31, 2:33 am |
| http://www.newstarget.com/z020236.html
NewsTarget.com printable article
Originally published August 30 2006
Common antibiotics cause tendon ruptures; Public Citizen demands black box
warnings
(NewsTarget) In response to reported cases of tendon ruptures associated
with fluoroquinolone antibiotics, consumer group Public Citizen petitioned
the FDA this week to require a black box warning about the side effect
rather than the current warning, which the group claims is buried in a list
of possible side effects and is inadequate.
"Tendon ruptures associated with these drugs continue to occur at a
disturbing rate, but could be prevented if doctors and patients were more
aware of early warning signals, such as the onset of tendon pain, and
switched to other antibiotics," said Sidney Wolfe, director of Public
Citizen's Health Research Group. "The FDA must act and require black box
warnings and patient information guides."
According to the Public Citizen's petition, Achilles tendons were the most
frequently ruptured, which can cause sudden, severe pain and difficulty
walking. It added that tendon ruptures in rotator cuffs, shoulders, biceps,
hands and thumbs had also been reported. The petition theorized that the
ruptures could be occurring because fluoroquinolones are toxic to tendon
fibers and may restrict blood supply in tendons, where it is already
limited.
The black box warning -- in which side effects are printed in bold type in
an easy-to-see black box -- is considered the FDA's most severe warning
against a drug's side effects. The warning traditionally appears at the top
of drug labels and is required to be included as part of any advertisements
for the drug.
A statement released by Ortho-McNeil Inc., the subsidiary of Johnson and
Johnson that makes Levaquin, said that the warning was unnecessary as the
drug's label already "clearly states tendon rupture can occur during or
after treatment with fluoroquinolones" and "adequately details the potential
risks" of using the drug.
A spokesperson for Schering-Plough Corp., the company who markets Cipro in
the United States on behalf of Bayer, said that neither they nor Bayer would
be issuing a comment about the petition.
Public Citizen is not the first group to file a petition with the FDA
regarding this drug. In May, the Illinois Attorney General petitioned the
FDA to put black box warnings on fluoroquinolone antibiotics, but the
administration responded that it needed more time to respond. While filing a
supplement to the petition Tuesday, the Attorney General's office requested
the FDA take action on both petitions.
"I think most people would be shocked to discover that these antibiotic
drugs cause tendon ruptures," said Mike Adams, a consumer health advocate.
"Burying the warning in a long list of other side effects presented in a
tiny font is not sufficient. Consumers need to be made acutely aware
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