WASHINGTON, Oct 30 (Reuters Health) -The US Food and Drug Administration (FDA) is calling upon the makers of the generic antibiotics doxycycline and penicillin to revise the drugs' labeling to indicate they can treat inhaled anthrax.
In a notice published Tuesday in the Federal Register, the FDA clarified that doxycycline and penicillin G procaine can be used to treat all forms of anthrax, including the inhaled form.
At present, the FDA said Bayer AG's antibiotic Cipro (ciprofloxacin) is the only antibiotic with specific labeling for inhaled anthrax largely because prior to October, inhaled anthrax was not considered a major public health concern.
Anthrax infections are caused by a spore-forming bacterium that can get into the body via skin contact, ingestion or inhalation. Inhaled anthrax is the deadliest form.
Until this month, anthrax infections in the US were rare and, in recent decades, limited to skin infections due to exposure to infected animals and animal products-usually among workers who handled them.
Cipro was approved to fight inhalation anthrax in August 2000. At the time, Bayer and government agencies requested that specification because of fears that the use of Cipro to treat inhaled anthrax without a specific indication would be considered experimental.
But the FDA said Tuesday that it is important to note that the animal research supporting the approval of Cipro also included separate doxycycline and penicillin arms, in which both drugs were shown to be effective.
The FDA also observed that these studies failed to evaluate other anti-microbial agents, some of which may also prevent or reduce the incidence of anthrax infections.
Based on published clinical studies and the Cipro research, the FDA said it was able to determine the specific doses of doxycycline and penicillin G procaine that should be given to adults and children with inhalation anthrax.
In a notice published Tuesday in the Federal Register, the FDA clarified that doxycycline and penicillin G procaine can be used to treat all forms of anthrax, including the inhaled form.
At present, the FDA said Bayer AG's antibiotic Cipro (ciprofloxacin) is the only antibiotic with specific labeling for inhaled anthrax largely because prior to October, inhaled anthrax was not considered a major public health concern.
Anthrax infections are caused by a spore-forming bacterium that can get into the body via skin contact, ingestion or inhalation. Inhaled anthrax is the deadliest form.
Until this month, anthrax infections in the US were rare and, in recent decades, limited to skin infections due to exposure to infected animals and animal products-usually among workers who handled them.
Cipro was approved to fight inhalation anthrax in August 2000. At the time, Bayer and government agencies requested that specification because of fears that the use of Cipro to treat inhaled anthrax without a specific indication would be considered experimental.
But the FDA said Tuesday that it is important to note that the animal research supporting the approval of Cipro also included separate doxycycline and penicillin arms, in which both drugs were shown to be effective.
The FDA also observed that these studies failed to evaluate other anti-microbial agents, some of which may also prevent or reduce the incidence of anthrax infections.
Based on published clinical studies and the Cipro research, the FDA said it was able to determine the specific doses of doxycycline and penicillin G procaine that should be given to adults and children with inhalation anthrax.
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