October 22, 2001
Bayer Supports FDA Approval of Doxycycline for Treatment Of
All Forms of Anthrax
- 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
"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
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