FDA Issues Cyber-Letters to Web Sites Selling Unapproved Foreign Ciprofloxacin (11/1/2001)
The Food and Drug Administration has taken steps to protect the American public against potentially useless or harmful drugs to treat anthrax infection that are being marketed by foreign Web sites in defiance of United States laws. The agency has issued warnings to 11 internet vendors abroad who are offering to American consumers ciprofloxacin, the generic name for Cipro. The FDA is unable to determine whether these products were made in accordance with U.S. specifications and, therefore, their sale and distribution in the U.S. may be illegal.
The agency has notified the recipients of the 11 "cyber letters" that it is taking several actions to halt potentially illicit drug sales that have emerged in the wake of the recent bioterrorist attacks in the U.S. The FDA is warning U.S. citizens that foreign drugs promoted on the internet may not be approved for marketing in this country and may not be legally imported. The agency is informing regulatory officials in the countries in which the Internet pharmacies operate that these potential violations are taking place; and it is advising the U.S. Customs Service that shipments from these vendors may be detained and refused entry.
FDA has also identified five other foreign-based Websites that are selling ciprofloxacin despite previous warnings from the agency about the U.S. requirements applicable to the sale of prescription drugs. The agency is taking additional measures to block their exports to this country and to secure the assistance of foreign authorities to stop these illicit sales.
FDA approves a drug based on scientific data that demonstrates that the drug is safe and effective. FDA cannot assure that ciprofloxacin purchased from abroad is safe or effective. (See FDA’s Tips and Warnings about Buying Medical Products Online ). According to the World Health Organization, counterfeiting of drugs is a serious problem in many foreign countries. Foreign manufactured ciprofloxacin has not been approved or evaluated by FDA, and the manufacturing practices for production of these drug products has not been regulated by the agency to assure the drug’s safety, identity, strength, quality, or purity.
Consumers should be aware of the following risks associated with obtaining a prescription drug over the internet:
- The product could be contaminated and harmful.
- The product could be a counterfeit and not contain the drug’s active ingredient.
- The product could contain the wrong dose of the drug.
- Without adequate screening by a health care professional, the product may not be safe and appropriate for the user.
- The consumer may not have access to a health care professional if a serious side effect occurs after taking the product.
- The consumer may receive no product at all after sending payment.
Ciprofloxacin is a powerful antibiotic that should be taken only after consultation with a health care provider. Because ciprofloxacin 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 ciprofloxacin treatment.
Ciprofloxacin should not be administered unless exposure to the bacterium that causes anthrax (Bacillus anthracis) is suspected or confirmed. Ciprofloxacin does not prevent exposure to anthrax, and the use of the drug in the absence of suspected or confirmed anthrax exposure could result in the development of antibiotic resistance, a serious public health risk. For additional information on ciprofloxacin visit FDA’s website at: http://www.fda.gov/cder/drug/infopage/cipro/.
Federal law generally does not permit individuals to import drugs that are not approved in the U.S., including foreign versions of U.S. approved drugs. Under the agency’s longstanding policy, FDA has permitted individuals who are under appropriate medical supervision for treatment of a serious condition to bring into the U.S. small quantities of drugs that are not approved in this country, if no equivalent product is available domestically. Since an approved version of ciprofloxacin is manufactured and available in the U.S., personal importation of this drug is not permitted. Under federal law, any drug that is manufactured in the United States and exported abroad may only be re-imported into the United States by the drug’s manufacturer.
For more information on buying drugs over the internet or to view the cyber letters visit FDA’s websites at: http://www.fda.gov/cder/drug/consumer/buyonline/guide.htm and http://www.fda.gov/cder/warn/cyber/cyber2001.htm.
For additional tips on buying products online from sellers who claim that their products will protect you from biological threats, see the FTC Consumer Alert at: http://www.ftc.gov.