Levaquin Approved to Treat or Prevent Plague
Deadly disease rare in the United States
URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_124598.html
(*this news item will not be available after 07/26/2012)
Friday, April 27, 2012
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 infection.
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 plague, 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.
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 plague, 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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