Cipro (Ciprofloxacin Hydrochloride)
for Inhalation Anthrax
Information on Cipro for Consumers: Questions and
Answers
- What is Cipro?
- Is Cipro approved for anthrax?
- Is Cipro the only product approved to
treat anthrax infections?
- If I know someone who was exposed to anthrax should I be treated
with Cipro?
- Should I ask my doctor to write a prescription for Cipro in case
it's needed?
- Why is FDA discouraging widespread use of Cipro?
- What are some possible side effects of Cipro?
- What else should I know about Cipro treatment?
- Is it safe to purchase Cipro online?
- Can individuals import Cipro under FDA's personal
importation policy?
1. What is Cipro?
Cipro (ciprofloxacin hydrochloride) is an antibiotic used to treat
bacterial infections in many different parts of the body. It does not work
for viral infections (for example, the common cold).
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2. Is Cipro approved for anthrax?
Cipro is approved for use in patients who have been exposed to the
inhaled form of anthrax.
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3. Is Cipro the only product approved to
treat anthrax infections?
No. There are a number of antibiotics that are currently indicated to
treat anthrax infections including doxycycline and penicillin. These older
antibiotics are readily available. FDA is stressing that any antibiotic
should only be used by those who really need it because unnecessary
antibiotic use exposes patients to the risks of a drug without any
potential benefit.
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4. If I know someone who was exposed to anthrax should I be treated
with Cipro?
Direct person-to-person spread of anthrax is extremely unlikely, if it
occurs at all. Therefore, there is no need to treat contacts of persons
ill with anthrax, such as household contacts, friends, or coworkers,
unless they also were also exposed to the same source of infection. (From http://www.bt.cdc.gov/DocumentsApp/FactsAbout/FactsAbout.asp)
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5. Should I ask my doctor to write a prescription for
Cipro in case
it's needed?
No. Although FDA does not regulate the practice of medicine, the agency
is strongly recommending that physicians not prescribe Cipro for
individual patients to have on hand for possible use against inhaled
anthrax. Any needed antibiotics from the current stockpile will be made
available if they are needed. In the meantime, Cipro should not be
prescribed unless there is a clear need, so that the drug will be
available when it is needed to treat other more common infections. (Excerpts from http://www.hhs.gov/news/press/2001pres/20011010a.html)
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6. Why is FDA discouraging widespread use of Cipro?
Random prescribing and extensive use of Cipro could speed up the
development of drug-resistant organisms, and the usefulness of Cipro as
an antibiotic may be lost. (Excerpts from http://www.hhs.gov/news/press/2001pres/20011010a.html
and http://www.bt.cdc.gov/)
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7. What are some possible side effects of Cipro?
(This list is
NOT a complete list of side effects reported with Cipro. Your health
care provider can discuss with you a more complete list of side effects.)
Some possible side effects of Cipro include:
- central nervous system (CNS) side effects including: dizziness,
confusion, tremors, hallucinations, depression, increased risk of
seizures
- an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives)
- pain, inflammation, or rupture of a tendon
- a severe tissue inflammation of the colon
- increased sensitivity of the skin to sunlight
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8. What else should I know about Cipro treatment?
In deciding to use a medicine, the risks of taking the medicine must be
weighed against the good it will do. If a person is exposed to anthrax the
risk of adverse events caused by Cipro treatment may be acceptable
because of the seriousness of the disease. However, if a person is not
exposed to anthrax these risks may outweigh the benefits.
Some things to consider:
- The safety and effectiveness of Cipro in individuals less than 18
years of age is not established, except for post-exposure in
inhalational anthrax. Cipro has been shown to cause bone development
problems in young animals.
- There have been no formal clinical studies of the safety and
effectiveness of Cipro in pregnancy. However, based on available
information, TERIS (The Teratogen Information System) has concluded
that Cipro used during pregnancy is unlikely to cause physical
defects to an unborn baby. But, there is not enough information to say
there is no risk. Guidelines for treating pregnant women with Cipro
are limited. An expert panel, The Working Group on Civilian
Biodefense, recommends that Cipro be used at usual adult doses to
treat pregnant women exposed to anthrax. Pregnant women should always
consult their health care provider before taking any medications.
- Before taking Cipro review ALL medications that you are
taking with your health care provider, including those that you take
without a prescription. Cipro can interact with other medicines,
including multivitamins.
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9. Is it safe to purchase Cipro online?
There are online pharmacies that provide legitimate prescription
services. Unfortunately, there are also questionable sites that make
purchasing medicines online risky. Purchasing a medication from an illegal
Website puts you at risk. You may receive a contaminated or counterfeit
product, the wrong product, an incorrect dose, or no product at all. Go
to: http://www.fda.gov/oc/buyonline/default.htm
for additional tips on buying medicines online.
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10. Can individuals
import Cipro under FDA’s personal importation policy?
Cipro is a powerful antibiotic that
should only be started after consultation with a health care provider.
Because Cipro is associated with side effects (some of which may be
serious) and may interact with other drugs, it is important to have access
to the prescribing health care provider during Cipro treatment. Cipro
should not be administered unless exposure to the bacterium that causes
anthrax (Bacillus anthracis) is suspected or confirmed. Cipro does
not prevent exposure to anthrax and use of Cipro in the absence of
suspected or confirmed anthrax exposure could result in the development of
antibiotic resistance, a serious risk to the public’s health.
FDA cannot assure that Cipro (or any
other drug) purchased abroad is safe, effective, and not a counterfeit
product, even if the labeling appears to be that of the genuine product.
The counterfeiting and adulteration of drugs is a widespread problem in
many foreign countries.
The Federal Food, Drug, and Cosmetic Act
(FFDCA) does not permit the importation (including importation for
personal use) of unapproved foreign versions of drugs which are approved
for use in the US. FDA does exercise limited enforcement discretion in the
case of individuals wishing to import an unapproved drug for their
personal use, but only if the drug in question does not have an
approved version available in the US. Since an approved version of Cipro
is available in the US, personal importation of any unapproved version is
not permitted.
For more information about Cipro, please contact the Division of
Drug Information at druginfo@fda.hhs.gov or
1-888-INFOFDA (463-6332).
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Back to Cipro Information
FDA/Center for Drug Evaluation and Research
Last Updated: November 14, 2001
Originator: OTCOM/DLIS
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