FDA Approves Avelox for Treatment of Plague
Yersinia pestis bacterium could be released intentionally in bioterrorism
MONDAY, May 11, 2015 (HealthDay News) -- Avelox (moxifloxacin) was approved by the U.S. Food and Drug Administration on Friday to treat plague, a rare but deadly bacterial infection that can strike the lungs (pneumonic), blood (septicemic), or lymph nodes (bubonic).
Only 1,000 to 2,000 cases are reported worldwide annually, the agency said in a news release. It's spread by the bites of infected fleas, or by contact with infected animals or people. However, the Yersinia pestis bacterium could be released intentionally as a bioterrorism agent.
Avelox was approved under rules that allow findings from well-controlled animal studies (in this case, African green monkeys) in instances when it isn't ethical or feasible to conduct trials among humans. The disease is so rare that it wouldn't be possible to conduct adequate trials involving people, the FDA said.
Avelox's label carries a boxed warning of the potential for tendinitis and tendon rupture, and worsening muscle weakness among certain prone users. Other potential side effects include allergic reaction, liver damage, blood abnormalities, abnormal heart rhythm, and central nervous system problems.
Avelox is produced by Bayer Healthcare Pharmaceuticals, based Whippany, N.J.