FDA has approved Levaquin for the treatment of Plague

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Symptoms of Bubonic Plague

The U.S Food and Drug Administration (FDA) has approved Levofloxacin (Levaquin) for the treatment of Plague.

Plague is an infection that occurs both in humans and animals caused by a bacterium Yersinia Pestis (bacillus). Plague is usually transmitted by the bite of rodent flea (carrier for plague bacterium) or by handling the infected animals. Millions of people in Europe die due to Plague in the Middle Ages. Worldwide, 2861 cases have been reported in 10 countries as reported by World Health Organization (WHO) in 1995. The WHO reports 1,000 to 3,000 cases of plague every year.

There are mainly three different types of plague as Bubonic plague (Infection of the lymph), Pneumonic plague (Infection of the lungs), and Septicemic plague (Infection of the blood). Bubonic plague is the most common form of this disease. It has incubation period of 2 to 6 days. Headache, fever, weakness, aching limbs, Muscle pain and delirium develops in this condition followed by acute painful swelling of lymph nodes.

Three types of tests are usually done for the diagnosis of Plague; these include Blood culture, sputum culture and culture of lymph node aspirate. Patients suffering from plague require immediate medical care as if treatment is not provided within first 24 hours of infection, patient may die.

The approval of Levofloxacin (Levaquin) by FDA was based upon the study conducted in African green monkeys that were infected with the plague bacterium in a laboratory setting. Animals were given Levaquin and placebo randomly within six hours of the onset of fever after being infected. The primary end point of the study was survival. Of the 17 monkeys treated by Levaquin, 16 were survived (94%). Out of 7 monkeys treated by placebo, none of them survived.

“Today’s approval broadens the available therapeutic treatments for plague,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “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.”

LevaquinLevaquin is an antibiotic of fluoroquinolone drug class. It is a safer drug according to FDA studies and post marketing information for the existing uses.

Common side effects of Levaquin include nausea, headache, diarrhea, insomnia, constipation, and dizziness (reported in more than 3% of patients). Its major side effects include tendinitis and tendon rupture, worsening of muscle weakness in people suffering neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm. As risk to benefit ratio Plague is a very deadly disease and owing to this reason Levaquin can be used for treatment of plague.

Other drugs which are approved by FDA for treatment of plague include streptomycin, doxycycline, tetracycline, and other antibacterial drugs in the tetracycline group. Plague vaccine is no longer available in the United States.

Further Reading:

FDA

CDC

RXList

References:

Gage KL. Plague. In: Colliers L, Balows A, Sussman M, Hausles WJ, eds. Topley and Wilson’s microbiology and microbiological infections, vol 3. London: Edward Arnold Press, 1998:885-903.

Bahmanyar M, Cavanaugh DC. Plague Manual. Geneva: World Health Organization, 1976.

Campbell GL, Dennis DT. Plague and other Yersinia infections. In: Kasper DL, et al; eds. Harrison’s principles of internal medicine. 14th ed. New York: McGraw Hill, 1998:975-83.

Bahmanyar M, Cavanaugh DC. Plague Manual. Geneva: World Health Organization, 1976.

Perry RD, Fetherston JD. Yersinia pestis–etiologic agent of plague. Clin Microbiol Rev, 1997;10:35-66.

Butler T. Plague and other Yersinia infections. New York, Plenum Press, 1983.