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FDA will approve new labeling for antibiotics to treat anthrax

מתוך medicontext.co.il

By Ori Twersky

WASHINGTON (Reuters Health) -The US Food and Drug Administration (FDA) said on Thursday that it will approve new labeling for several antibiotics for the treatment of anthrax.

As part of the announcement, the agency provided recommendations for clinicians on the use of doxycycline for anthrax. It added that it is "developing more information about the use of this and other antibiotics to treat anthrax and will provide this information soon."

The FDA's recommendations clarify the correct dosing regimen for doxycycline to help healthcare providers prescribe the drug. But they also serve the purpose of reminding Americans that Bayer's Cipro (ciprofloxacin) is not the only treatment for the potentially deadly infection.

Cipro, which was approved as an anthrax treatment last year, is considered the drug of choice because of concerns that engineered anthrax strains could be resistant to older antibiotics. But it is not the only option. In fact, over a dozen antibiotics have been approved for use against anthrax.

Dr. Sandra Kweder, acting director of the FDA's Office of Review Management, told Reuters Health that the FDA issued the recommendation on doxycycline to ensure that patients receive a high enough dose to counter the bacteria. Doxycycline is already approved to treat all forms of anthrax, including the inhaled form that took the life of the tabloid employee in Florida, she noted.

Kweder said adults with severe disease should receive a 100-mg dose of doxycycline every 12 hours and that children under 100 pounds should receive 1 mg per pound every 12 hours. Treatment guidelines for the use of penicillin and other antibiotics will follow shortly, she added.

The anthrax used in the spate of recent US exposures appears not to have been engineered to resist the older antibiotics, meaning that there is little reason for Americans to be concerned about a shortage of drugs to treat exposure, Kweder stressed. She noted that there are numerous manufacturers of the older antibiotics and that, in any case, Bayer has enormous manufacturing capabilities for Cipro and will be able to meet the government's needs if individuals do not horde the drug.

The FDA and other health authorities have strongly discouraged doctors from prescribing antibiotics without a clear indication that exposure may have occurred and have urged individuals not to use any antibiotic without consulting a physician.

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