FDA Approves Treatment for Plague

The FDA today approved Bayer HealthCare Pharmaceuticals' moxifloxacin (Avelox) to treat plague.

Avelox is intended to treat pneumonic plague and septicemic plague, and it can also be used to prevent plague among adults.

Because cases of plague are rare across the world, the FDA approved Avelox based on a trial with African green monkeys infected with Yersinia pestis, a bacteria that could potentially be used as a bioterrorism agent. Following at least 4 hours after the onset of fever, the monkeys were randomly assigned to receive a 10-day regimen of Avelox or a placebo.

All of the monkeys treated with Avelox survived, while all 10 of the monkeys who received the placebo died.

Patients who take Avelox may experience adverse side effects, such as nausea, diarrhea, headache, and dizziness. In addition, the drug’s Boxed Warning states that it may increase patients’ risk of tendinitis and tendon rupture, plus muscle weakness among individuals with neuromuscular disorder myasthenia gravis. Other adverse side effects could include liver damage and abnormal heart rhythm.

“However, given that plague is a very serious and often deadly condition, the benefit of Avelox for treating plague outweighs these potential risks,” an FDA press release stated.

The most common types of plague are bubonic, pneumonic, and septicemic, and the rare and potentially fatal bacterial infections affect around 1000 to 2000 patients each year around the globe.