Federal regulators – The Food and Drugs Administration (FDA), have approved use of an antibiotic to treat plague, an extremely rare, sometimes-fatal bacterial infection.
Levaquin, known generically as levofloxacin, is produced by Raritan, N.J.-based Janssen Pharmaceuticals, a unit of Johnson & Johnson. The FDA also approved it to reduce risk of people getting plague after exposure to the bacteria that cause it. Called Yersinia pestis, the bacteria are considered a potential bioterrorism agent.
The approval for Levaquin came after tests on African green monkeys infected with the bacteria in a lab found 94 percent of the monkeys given Levaquin survived. 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.
Plague mainly occurs in animals. People can get it from bites from infected fleas or contact with infected animals or humans. About 1,000 to 2,000 human cases occur worldwide each year. The three most common forms of plague include bubonic (affecting the lymph nodes), pneumonic (lungs) and septicemic (blood stream).
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.
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