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U.S. Department of Health and Human Services

Drugs

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FDA Encourages Drug Firms to Revise Doxycycline and Penicillin G Procaine Labeling with Information for Treating Inhalational Anthrax (Post-Exposure)

The Food and Drug Administration (FDA) today issued a Federal Register notice to clarify that the antibiotics doxycycline and penicillin G procaine are currently approved for use in treating all forms of anthrax infections -- cutaneous (skin), inhalational and gastrointestinal.

The notice also includes explicit dosing and other useful information on the use of doxycycline and penicillin G procaine to treat inhalational anthrax (post-exposure) in adults and children. FDA is encouraging companies to update labeling of these products with this previously unspecified information.

FDA developed the dosing information for inhalational anthrax (post-exposure) based on its review of published scientific literature and the separate doxycycline and penicillin G procaine arms of the same rhesus monkey study used to support the August 2000 approval of Cipro(ciprofloxacin) for the same use. The doxycycline and penicllin G arms of the rhesus monkey study showed a survival advantage over placebo.

Doxycycline and other members of the tetracycline class of antibiotics are not generally indicated for the treatment of any patients under the age of 8 years because of their negative effects on teeth and bone development. However, FDA believes the benefits of doxycycline for the treatment of inhalational anthrax (post-exposure) outweigh these risks.

The full-text of the Federal Register notice can be found online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110201b.htm.

Today's action is part of the agency's ongoing efforts to explicitly label products that can be used to combat bioterrorism.

FDA and other health authorities strongly discourage individuals from taking any antibiotic for prevention of anthrax without the specific advice of a physician and a clear indication that exposure may have occurred. Unnecessary antibiotic use exposes patients to serious risks without any potential benefit. Moreover, the indiscriminate use of antibiotics could speed-up the development of drug-resistant organisms and may cause the usefulness of an antibiotic to be lost.