WASHINGTON (AP) - Drug safety officials are calling for an
urgent safety warning for Cipro (SIH'-proh) and similar
antibiotics.
The Food and Drug Administration is ordering the "black box"
wording due to evidence the drugs may lead to tendon ruptures. They
say the ruptures could result in serious injury that can leave
patients incapacitated and in need of extensive surgery.
The makers of the potent class of antibacterials will also need
to develop new literature for patients to emphasize the risks. The
two leading drugs covered by the warning are Cipro, made by Bayer,
and Levaquin (LEE'-vah-kwin), which is made by Ortho-McNeil.
Tendon ruptures normally result from sports injuries. The link
to treatment with the antibiotics is highly unusual, and scientists
still don't fully understand why it happens.
FDA officials said they had received several hundred reports of
tendon ruptures. However, FDA officials say many of the serious
injuries could be preventable if patients stop taking the drug at
the first sign of pain or swelling in a tendon, call a doctor, and
switch to another antibiotic.