Posted tagged ‘plague bacterium’

Plague Medication Approved by the FDA

June 7, 2012

(June 7, 2012) At the end of May, the U.S. Food and Drug Administration (FDA) approved a drug to treat patients with plague, a rare and potentially life-threatening bacterial infection.

 

In addition, Levaquin (levofloxacin) was also approved to reduce the risk of getting plague after exposure to a bacterium, which causes the disease, known as Yersinia pestis.

 

Although plague is extremely rare in most parts of the world (only 1,000 to 2,000 cases per year), and is primarily an animal disease, plague may be spread to humans from an infected flea, contact with infected animals, or laboratory exposure.

 

The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood).

 

The Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, Edward Cox, M.D., M.P.H., said that this “approval broadens the available therapeutic treatments for plague. It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible.”

 

The agency approved Levaquin under the Animal Efficacy Rule, which allows research on animals in cases where it is not feasible or ethical to conduct trials in humans, so long as the studies are adequate and well-controlled.

 

The study was conducted on African green monkeys infected with the plague bacterium in a lab setting. Animals were randomly selected to receive a 10-day regimen of Levaquin or placebo within six hours of the onset of fever after being infected. 94 percent of the 17 monkeys (roughly 16) treated with Levaquin survived, but none of the seven monkeys treated with the placebo survived.

 

Common side effects of Levaquin, reported in more than three percent of patients, were nausea, headache, diarrhea, insomnia, constipation, and dizziness. In addition, such rare but serious side effects include tendinitis and tendon rupture, worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm.

 

As always, when dealing with these FDA-approved drugs, is to determine if taking this medicine is worth it in your situation, and decide if the risks in not taking the medication outweigh the benefits that the medication provides. Since plague is a very serious, potentially deadly condition, it would almost always seem that taking Levaquin outweighs any risk of its side effects.

 

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