FDA Approves Anthrax Antibiotic

If bioterrorists ever attack the United States with anthrax, the antibiotic Cipro will be the first line of defense for civilians who breathe the deadly bacteria, the government decided Thursday.

The Food and Drug Administration said Bayer Corp.'s popular antibiotic will help protect people exposed to inhaled anthrax from becoming infected and dying if they take it quickly enough.

Cipro, known chemically as ciprofloxacin, has been sold for 13 years to treat a variety of infections, and many experts long believed it would fight anthrax, too.

But FDA's formal approval of Cipro Thursday makes it the nation's first medication specifically designated for use after bioterrorism, a sign federal health officials have begun taking the threat seriously.

Public health experts have warned for several years that the nation is unprepared for the growing risk of bioterrorism, the release of deadly bacteria or viruses. Germs are the ultimate sneak attack: Unlike with bombings or chemical spills, no one would know an attack had happened until sick people began arriving at hospitals.

It's not a theoretical risk. In 1985, a cult sickened 750 Oregonians by tainting salad bars with the food-poisoning germ salmonella. Experts say Japanese doomsday cultists tried but failed to release botulism toxin and anthrax in Tokyo in 1995, before they released nerve gas into a subway, killing 12 people and sickening thousands.

Anthrax is a spore-forming bacteria found in soil. When it is aerosolized and inhaled, it becomes incredibly deadly. It is of particular concern because it has been manufactured as a biological weapon by at least three nations, Russia, Iraq and Iran. Just a few pounds of spores released into air conditioning units or sprayed over a crowd could infect thousands.

Eighty percent of inhaled anthrax victims die within days if they go untreated. To be most effective, Cipro should be taken within hours of anthrax exposure, said FDA antibiotic chief Dr. Gary Chikami. Once symptoms— fever, chills, rash and respiratory congestion— appear, little can be done.

The FDA's approval "is a welcome step forward" because for the first time it sets the proper Cipro dose for both adults and children, said Michael Osterholm of the Infection Control Advisory Network, who advises the government on bioterrorism.

But Osterholm complained that the nation still spends far too little readying for bioterrorism, compared with billions spent against missile attacks and other threats now considered less likely thanks to technology.

The Department of Health and Human Services is spending $278 million this fiscal year on bioterrorism preparedness. That includes stockpiling enough Cipro for 5 million treatments. Osterholm would not reveal how much already is stockpiled, but said, "we've got a ways to go."

There was no way to test Cipro's effectiveness in people suffering inhaled anthrax, so the FDA based its approval largely on a stuy of monkeys, who suffer anthrax in almost the same way that people do. Nine out of 10 untreated monkeys died after inhaling anthrax; only one out of nine Cipro-treated monkeys died.

Adults would take 500 milligrams of Cipro orally twice a day for 60 days after anthrax exposure; children would take it for as long but at doses proportional to their weight.