Ciprofloxacin hydrochloride is indicated for inhalational anthrax (post-exposure), to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized Bacillus anthracis spores (1).

Ciprofloxacin reduces the risk of severe disease following exposure, but does not prevent exposure to aerosolized Bacillus anthracis. If a person is exposed to B. anthracis, the risk of adverse events caused by Ciprofloxacin hydrochloride therapy may be acceptable because of the severity of this disease. However, in the absence of exposure, the risk of side effects may not be acceptable. Possible adverse events and other concerns include:

• CNS effects (dizziness, confusion, tremors, hallucinations, depression, increased risk of seizures).

• Drug Interactions. Ciprofloxacin may increase levels of theophylline and caffeine, other vitamin and drug products may reduce availability of ciprofloxacin.

• Hypersensitivity.

• Pseudomembraneous colitis.

• Tendonitis/tendon rupture.

• Photosensitivity.

Use of an antibiotic inappropriately (for example when exposure has not been confirmed) can lead to the emergence of resistant strains of bacteria. The usefulness of ciprofloxacin hydrochloride as an antibiotic may be lost if widespread use occurs. The safety and effectiveness of ciprofloxacin in patients less than 18 years of age is not established except for post-exposure use in inhalational anthrax. Ciprofloxacin causes arthropathy in juvenile animals.

Fluroquinolones are not generally recommended during pregnancy because of their known association with arthropathy in adolescent animals. However, animal studies have not shown evidence of teratogenicity related to exposure to ciprofloxacin (2). A 1999 consensus statement by the Working Group on Civilian Biodefense recommends that ciprofloxacin be used at usual adult doses in pregnant women for therapy and postexposure prophylaxis following anthrax exposure (3).

References

1. http://www.fda.gov/cder/drug/infopage/ or through: druginfo@cder.fda.gov

2. Friedman, J.M., Polifka, J.E. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press; pp. 149-150, 2000.

3. Inglesby, T.V. et al. Anthrax as a biological weapon: medical and public health management. Working Group on Civilian Biodefense. Journal of the American Medical Association, 281: 1735-1745 (1999). Erratum in: Journal of the American Medical Association, 283: 1963 (2000)