Levaquin Approved to Treat or Prevent Plague04/27/12
FRIDAY, April 27 (HealthDay News) -- Approval of the antibiotic
Levaquin (levofloxacin) has been expanded by the U.S. Food and Drug
Administration to include plague, a rare but deadly bacterial
The disease is extremely rare in the United States, and only
about 1,000 to 2,000 cases occur each year across the globe, the
agency said in a news release. The three most common forms of
plague include bubonic (affecting the lymph nodes), pneumonic
(lungs) and septicemic (blood stream).
Animals are most frequently infected, although plague can be
spread to people by fleas, contact with infected animals or other
people, or by exposure in the laboratory. The bacterium that causes
Yersinia pestis, is considered a potential bioterrorism agent, the FDA said.
Levaquin was tested under the agency's Animal Efficacy Rule,
which allows findings from carefully controlled tests in animals to
be applied to people. It would not be ethical or feasible to
conduct clinical testing of the drug for this purpose in people,
the FDA said.
Known side effects of Levaquin include nausea, headache,
diarrhea, insomnia, constipation and dizziness. More serious but
rare adverse reactions could include tendinitis and tendon rupture,
allergic reactions, liver damage, blood and nervous system
problems, and abnormal heart rhythm, the agency said.
Levaquin is produced by Raritan, N.J.-based Janssen
Pharmaceuticals, a unit of Johnson & Johnson.
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