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SafetyAlerts
October 22, 2001

Bayer Supports FDA Approval of Doxycycline for Treatment Of All Forms of Anthrax

 

 (SafetyAlerts) -  Bayer Corporation announced today its support of the U.S. Food and Drug Administration's recent decision to approve additional labeling on doxycycline, authorizing the use of this antibiotic for the treatment of all forms of anthrax.

Bayer recently announced that it is tripling its shipments of Cipro to deliver 200 million tablets of the antibiotic during the next three months. With the greatly expanded supplies of Cipro that Bayer is now producing, combined with the supplies of doxycycline and penicillin produced by other pharmaceutical manufacturers, the company believes the public has every reason to be assured that public health authorities will be able to deal swiftly and effectively with any anthrax threat.

Bayer's production facilities for Cipro are operating on a 24-hour, seven-day-per- week schedule. With this new additional government guidance for the treatment of anthrax published by the U.S. FDA, there will be ample supply of antibiotics available to millions of people for anthrax exposure through emergency stockpiles.

Bayer also reconfirms that it has filled every request for Cipro by the U.S. and Canadian governments, and remains committed to meeting the emergency needs of both North American governments in the future.

"While we understand why individuals want to be personally prepared in the event of any exposure to anthrax," said Dr. Wolfgang Plischke, Executive Vice President of Bayer Corporation and President of the Pharmaceutical Division, North America. "We fully support the efforts of HHS Secretary Thompson and Surgeon General Satcher in their advice to Americans regarding the dangers of taking antibiotics 'just in case,' and also of hoarding these vital products.

"We have also increased our support of these public awareness efforts through advertisements in major newspapers and other initiatives in the hope that greater public awareness will reduce the unnecessary use of Cipro and other antibiotics." Dr. Plischke said.

"In addition to our intense focus on supply of Cipro, Bayer is also working closely with physicians, pharmacies and healthcare officials to help ensure the proper use of antibiotics," he said.

The Food and Drug Administration on Oct. 18 issued the following Public Health Advisory:

FDA Public Health Advisory:
Update On Use Of Doxycycline For Anthrax Exposure


Secretary of Health and Human Services Tommy G. Thompson announced on October 17 in testimony before the Committee on Governmental Affairs and Subcommittee on International Security, Proliferation and Federal Services of the United States Senate, that the Food an Drug Administration is approving new labeling for the use of several antibiotics to treat anthrax.

The following is being issued to provide healthcare providers with clarification on dosing regimens about doxycycline. In addition, FDA is developing more information about the use of this and other antibiotics to treat anthrax and will provide this information soon.

Doxycycline is approved for the treatment of anthrax in all its forms. The FDA is providing additional information concerning the dosing regimen for the treatment of anthrax, including cutaneous and inhalation anthrax (post-exposure). The currently recommended dosage regimen of doxycycline for severe disease is 100 mg every 12 hours for adults and 1 mg per pound (2.2mg per kilogram) every 12 hours for children less than 100 pounds. These dosage regimens are appropriate for use in patients who have been exposed to anthrax (Bacillus anthracis) regardless of the route of exposure.

FDA and other health authorities strongly discourage individuals from taking any antibiotic for prevention of anthrax without the specific advice of a physician and a clear indication that exposure to the organism may have occurred.

Source: PRNewswire.

 
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Health Professional:

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During 2000 there were over
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.