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Archive for Sunday, July 30, 2000

FDA panel recommends anthrax treatment drug

July 30, 2000

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— An advisory committee recommended approval of an antibiotic for treatment of people exposed to inhaled anthrax, an action designed to help prepare the nation for a possible biological terrorist attack.

A Food and Drug Administration advisory committee voted unanimously Friday to recommend that the agency select ciprofloxacin as the first antibiotic formally approved for treating people who may have inhaled spores of anthrax.

Ciprofloxacin has been marketed for 13 years by Bayer Corp. of West Haven, Conn., under the brand name Cipro. The drug already is approved for a variety of infections and has been used by about 250 million patients worldwide. But there currently is no drug formally approved for preventing infection in people exposed to inhaled anthrax.

Committee chairman Dr. L. Barth Reller of Duke University said the unanimous vote of the committee "is clearly linked" to the unusual circumstances of preparing for a possible terrorist attack.

The FDA is not required to follow the committee recommendation, but approval is considered by insiders as almost certain. The FDA had requested that Bayer apply for the formal approval and some federal agencies had already recommended Cipro as the prophylactic drug of choice for people exposed to inhaled anthrax.

To be effective, experts said, Cipro would have to be taken by exposed patients before symptoms appear. Once the fever, chills, rash and respiratory congestion start, there is little than can be done, researchers said. This means that once it is known there has been a release of anthrax spores, people will, within hours, have to take an antibiotic, the experts said.

The FDA action is part of an organized effort by federal agencies to prepare the nation to respond to biological attack. A presidential directive two years ago called on federal agencies to coordinate efforts to protect against such attacks.

Cipro already has been identified by the Army and by the Centers for Disease Prevention and Control as the recommended antibiotic for post-exposure treatment of inhaled anthrax. The military stockpiled the drug during the Persian Gulf War, where there was a threat of biological weapons use.

The CDC also is poised to stockpile the drug, if it is approved. A plan calls for the agency to be prepared to distribute the stockpiled drug within hours after any biological terrorist attack.

When inhaled, anthrax rapidly produces toxins that cause severe damage to the respiratory system and brain. Untreated patients usually die within days.

Other researchers on Friday presented data from monkey studies that showed that Cipro and some other antibiotics could prevent infection from developing after inhaled anthrax exposure. The data, from an Army study, however, showed that inhaled anthrax spores in the lungs can remain dangerous and infectious for weeks.

No human studies have been conducted with inhaled anthrax and the advisory committee was asked to evaluate the use of Cipro against anthrax based only on the animal studies. Members of the committee noted, however, that Cipro has a long record of safety.

Anthrax bacteria has been manufactured as a biological weapon by at least three nations, Russia, Iraq and Iran. At least 14 other nations, according to a federal study, have biological weapons programs, but it is not known how many are using anthrax.

The deadliness of a spray of anthrax spores has been widely recognized. A congressional study concluded spraying just 200 pounds of anthrax spore over Washington, D.C. could killed up to three million people.

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