October 18, 2001
The Food and Drug Administration today issued the following Public Health Advisory:
FDA PUBLIC HEALTH ADVISORY: UPDATE ON USE OF DOXYCYCLINE FOR ANTHRAX EXPOSURE
Secretary of Health and Human Services Tommy G. Thompson announced on October 17 in testimony before the Committee on Governmental Affairs and Subcommittee on International Security, Proliferation and Federal Services of the United States Senate, that the Food and Drug Administration is approving new labeling for the use of several antibiotics to treat anthrax.
The following is being issued to provide healthcare providers with clarification on dosing regimens about doxycycline. In addition, FDA is developing more information about the use of this and other antibiotics to treat anthrax and will provide this information soon.
Doxycycline is approved for the treatment of anthrax in all its forms. The FDA is providing additional information concerning the dosing regimen for the treatment of anthrax, including cutaneous and inhalation anthrax (post-exposure). The currently recommended dosage regimen of doxycycline for severe disease is 100 mg every 12 hours for adults and 1mg per pound (2.2mg per kilogram) every 12 hours for children less than 100 pounds. These dosage regimens are appropriate for use in patients who have been exposed to anthrax (Bacillus anthracis) regardless of the route of exposure.
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 to the organism may have occurred.
The Food and Drug Administration
An Agency of the U.S. Department of Health and Human Services