News 05/11/2544

News 05/11/2544

FDA SUGGESTS DOXYCYCLINE, PENICILLIN G PROCAINE DOSES FOR INHALATION ANTHRAX
The US Food and Drug Administration (FDA) clarified Tuesday that doxycycline and penicillin G procaine are already approved for treatment of all forms of anthrax infections, including inhalation anthrax.

FDA Suggests Doxycycline, Penicillin G Procaine Doses for Inhalation Anthrax

WASHINGTON (Reuters Health) Oct 30 - The US Food and Drug Administration (FDA) clarified Tuesday that doxycycline and penicillin G procaine are already approved for treatment of all forms of anthrax infections, including inhalation anthrax.

In addition, the FDA provided specific dosage recommendations for these antibiotics for treatment of inhalational anthrax (post-exposure) in adults and children. A talk paper on the topic can be found on the agency's Web site at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01112.html.

Current labeling for doxycycline and penicillin G procaine carries a general anthrax indication and does not specify a dosing regimen for inhalational anthrax exposure. However, the FDA said it has "determined that the language in the labeling of drug products containing doxycycline, doxycycline calcium, doxycycline hyclate and penicillin G procaine is intended to, and does, cover all forms of anthrax, including inhalational anthrax (post-exposure)."

Bayer's ciprofloxacin (Cipro) already carries specific labeling for inhaled anthrax. The FDA noted that in a rhesus monkey study that was conducted to support the approval of Cipro for that indication, there were doxycycline and penicillin G procaine arms, and both drugs provided a survival advantage over placebo.