posted 09-08-2000 03:15 PM
Original Article from CNN
U.S. approves antibiotic to fight anthrax
September 1, 2000
WASHINGTON (Reuters) -- U.S. health officials, working to prepare the United States to face the threat of biological terrorism, Thursday approved a widely used antibiotic to fight infection with the deadly agent, anthrax.
Cipro, made by Bayer Corp., a division of German chemical group Bayer AG , is the first medication specifically approved for use in the event of a biological attack.
The U.S. government keeps a stockpile of medicines and other supplies on hand to deploy in case a biological weapon is unleashed. Officials say having the FDA's approval to use Cipro against anthrax makes it easier for agencies to stock the drug and ship it in times of emergency.
Anthrax is one of the most feared biological agents because it is nearly always fatal without treatment. Experts say an aerosol version released in a populated area could spread quickly and kill possibly millions in a matter of days unless antibiotics were given shortly after exposure.
Cipro, part of a powerful class of drugs called quinolones, is one of the world's top-selling antibiotics. More than 250 million people have been treated with the drug.
It would have been unethical to expose humans to anthrax bacteria in order to test whether Cipro might prevent disease. Instead, regulators relied on animal studies and blood samples from people given Cipro.
Studies showed levels of Cipro in human blood samples were equivalent to those in monkeys who were able to survive anthrax exposure. That helped the FDA conclude that Cipro was "reasonably likely" to help humans fight off anthrax.
Treatment with Cipro for anthrax should begin as soon as possible and last for 60 days, the FDA said.
Children also could receive Cipro treatment for anthrax exposure because the disease is so lethal, the FDA said. The drug, which has been on the market since 1987, had not previously been approved for children because of concerns about long-term safety.
Bayer is studying the effects of Cipro, the FDA said. Known side effects include nausea, vomiting, diarrhea, abdominal pain, rash, headache and restlessness.
Cipro, known generically as ciprofloxacin, is approved for treating 14 other types of infections.