The Food and Drug Administration has issued 11 "cyber-letters" to Internet vendors selling unapproved Ciproflaxin to US consumers.
"Cyber Letters" are issued by the FDA to warn Website operators that they may be engaged in illegal activities and informs them of the laws that govern prescription drug sales.
The FDA says it has taken the step of issuing the warning letters to protect the American public against potentially useless or harmful drugs to treat anthrax infection that are being marketed by foreign Websites in defiance of US laws.
Recipients of the 11 "cyber letters" have been notified that the FDA 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.
"Cyber Letters" have been issued to companies including Dublin-based USA Medicine.com Ltd, Canadian-based Mediplan Health Consulting Inc., Portugese-based Pharma Group, Malaysian-based Pharmacy International, Inc., and Swiss-based Farmamondo.
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.
The FDA is warning US citizens that foreign drugs promoted on the Internet may not be approved for marketing in the US and may not be legally imported.
The FDA says it is unable to determine whether these products were made in accordance with US specifications and, therefore, their sale and distribution in the US may be illegal.
Five other foreign-based Websites have also been identified, that are selling ciprofloxacin despite previous warnings from the agency about the US requirements applicable to the sale of prescription drugs.
The agency says it is taking additional measures to block their exports into the US and to secure the assistance of foreign authorities to stop these illicit sales.
Guidance issued to consumers by the FDA says they 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.