Drug Information

Cipro (Ciprofloxacin Hydrochloride)
for Inhalation Anthrax

Information on Cipro for Consumers:  Questions and Answers

1. What is Cipro?
2. Is Cipro approved for anthrax?
3. Is Cipro the only product approved to treat anthrax infections?
4. If I know someone who was exposed to anthrax should I be treated with Cipro?
5. Should I ask my doctor to write a prescription for Cipro in case it's needed?
6. Why is FDA discouraging widespread use of Cipro?
7. What are some possible side effects of Cipro?
8. What else should I know about Cipro treatment?
9. Is it safe to purchase Cipro online?
10. 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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Cipro is approved for use in patients who have been exposed to the inhaled form of anthrax.

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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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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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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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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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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).