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FDA Takes Action Against Illegal Internet Pharmacies

Agency participates in international operation to protect consumers from potentially dangerous, unapproved drugs (Oct. 4)

The FDA announced on October 4 that, in partnership with international regulatory and law-enforcement agencies, it took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.

The announcement took place during the fifth annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s effort — Operation Pangea V — operated between September 25 and October 2 and resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.

The goal of this annual effort, which involved law-enforcement, customs, and regulatory authorities from 100 countries, is to identify producers and distributors of illegal pharmaceutical products and medical devices and to remove these products from the supply chain.

During Operation Pangea V, the FDA targeted websites selling unapproved and potentially dangerous medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by the FDA for use only under the supervision of a licensed healthcare practitioner or active ingredients that were previously withdrawn from U.S. market because of safety issues.

Illegal medicines identified through the operation include:

  • Domperidone: This drug was removed from the U.S. market in 1998 because it may cause serious adverse effects, including irregular heartbeat, stopping of the heart, or sudden death. These dangers could be conveyed to the nursing babies of breastfeeding women, who may be using domperidone to try to increase milk production, which is not an approved use.
  • Isotretinoin (previously marketed as Accutane in the U.S.): This medicine is used to treat severe nodular acne and carries significant potential risks, including severe birth defects if pregnancy occurs while using the drug. To minimize potential risks to consumers, FDA-approved isotretinoin capsules are available only through restricted distribution in the U.S.
  • Tamiflu (oseltamivir phosphate): This medicine, which is used to treat the flu, is often sold online as “generic Tamiflu.” However, there is no FDA-approved generic version of Tamiflu. Previous FDA tests found that fraudulent versions of “generic Tamiflu” contained the wrong active ingredient, which would not be effective in treating flu. In these cases, the wrong active ingredient was similar to penicillin and may cause a severe allergic reaction, including sudden, potentially life-threatening anaphylaxis, in consumers allergic to penicillin products.
  • Viagra (sildenafil citrate): This medicine is used to treat erectile dysfunction. Because of its vasodilation effects, sildenafil citrate should not be used by consumers with certain heart conditions. Consumers taking this medicine without the supervision of a healthcare professional may not learn about potential drug interactions, such as increased blood pressure-lowering effects of organic nitrates when taken with sildenafil citrate.

The FDA sent warning letters to the operators of more than 4,100 identified websites. As a follow-up, the agency sent notices to Registries, Internet Service Providers (ISPs), and domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S. law. The FDA is working with its foreign counterparts to address the remaining websites that continue to offer unapproved or misbranded prescription medicines to U.S. consumers.

For more information, visit the FDA Web site.

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