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Levaquin OK'd to Treat Plague
MedPageToday, 2012The antibacterial agent levofloxacin (Levaquin) has been approved to treat and prevent the plague, the FDA announced.
The drug – already approved for a range of indications – got the nod under the FDA's Animal Efficacy Rule, which allows evidence from animal studies if it is not feasible or ethical to conduct trials in humans, the agency said in a release.
Human trials of the drug would be difficult because the plague – caused by the bacterium Yersinia pestis – is rare, with only 1,000 and 2,000 cases a year around the world.
Earlier this month, an agency of both levofloxacin and ciprofloxacin (Cipro) on the basis of animal studies.
The approval was based on a study in which African green monkeys were infected with Yersinia pestis and randomly given either levofloxacin or placebo for 10 days.
Of the 17 animals that got the drug, 94% survived, the FDA said, compared with none of the animals given placebo.
Known as the Black Death, the lymph node infection was thought to have killed between 30% and 60% of Europe's population.
The bacterium, which is primarily an animal pathogen, can also infect the lungs and the blood of humans -- pneumonic and septicemic plague, respectively.
The approval "broadens the available therapeutic treatments for plague," according to Edward Cox, MD, of the FDAʼs Center for Drug Evaluation and Research.
The agency noted that common side effects of levofloxacin include nausea, headache, diarrhea, insomnia, constipation, and dizziness.
More serious effects, although rare, include tendinitis and tendon rupture, worsening of muscle weakness in people with myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm.