WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) said on Tuesday that it is encouraging makers of the antibiotics doxycycline and penicillin G procaine to update their labels to include dosing information regarding treatment of post-exposure inhalational anthrax in adults and children.
The FDA has developed recommended dosing information based on a review of the scientific literature as well as a trial conducted to support the inhaled anthrax indication for Bayer's Cipro (ciprofloxacin) that also included doxycycline and penicillin G procaine arms.
Companies that wish to update their labels must submit labeling supplements to the agency.
The FDA stressed that doxycycline and penicillin are already approved to treat anthrax in all forms, including inhalational.
The drugs' current labeling carries a general anthrax indication and does not include 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)."
While doxycycline is not usually used in children under the age of eight because of negative effects on bone and tooth development, its benefits in treating inhaled anthrax exposure in young children outweigh the risks, the agency noted.
Cipro already carries specific labeling for inhaled anthrax. The FDA noted that a rhesus monkey study supporting the approval of that indication also included doxycycline and penicillin arms, in which both drugs were shown to provide a survival advantage over placebo.
The agency's notice, which includes its specific dosage recommendations, can be found on its Web site, www.fda.gov.
The FDA has developed recommended dosing information based on a review of the scientific literature as well as a trial conducted to support the inhaled anthrax indication for Bayer's Cipro (ciprofloxacin) that also included doxycycline and penicillin G procaine arms.
Companies that wish to update their labels must submit labeling supplements to the agency.
The FDA stressed that doxycycline and penicillin are already approved to treat anthrax in all forms, including inhalational.
The drugs' current labeling carries a general anthrax indication and does not include 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)."
While doxycycline is not usually used in children under the age of eight because of negative effects on bone and tooth development, its benefits in treating inhaled anthrax exposure in young children outweigh the risks, the agency noted.
Cipro already carries specific labeling for inhaled anthrax. The FDA noted that a rhesus monkey study supporting the approval of that indication also included doxycycline and penicillin arms, in which both drugs were shown to provide a survival advantage over placebo.
The agency's notice, which includes its specific dosage recommendations, can be found on its Web site, www.fda.gov.
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