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FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet
Date:9/29/2011

d Research, and the Office of Enforcement targeted 997 websites that are engaged in the illegal sale of unapproved and/or misbranded medicines to U.S. consumers.

During OPERATION PANGEA IV, FDA focused its efforts on websites selling unapproved drugs, such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. These unapproved drugs can be detrimental to public health.  Although some drugs containing these active ingredients are approved by FDA for use under the supervision of a licensed medical practitioner, the drugs offered for sale on these websites were not FDA approved, and were offered for sale without requiring a valid prescription.

Improper use of HGH can lead to side effects, including an increased risk of cancer, nerve pain, and elevated cholesterol or glucose levels. Sildenafil citrate tablets are used to treat erectile dysfunction and should not be used in some consumers with heart problems.  Isotretinoin capsules, previously marketed as Accutane in the United States, are used to treat severe nodular acne. The drug carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine.

To minimize potential risks, FDA approved isotretinoin capsules are only available through restricted distribution in the United States, and patients purchasing unapproved products containing this active ingredient are placed at a higher risk because, among other issues, they bypass existing safety controls.

The FDA sent Warning Letters to the operators of the identified websites, all of which appear to be associated with the same individuals and corporate entities located outside of the United States.

As a follow up, the agency sent notices to the Internet Corporation for Assigned Names and Numbers, Registries, Internet Service Providers (ISPs), and Domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S
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SOURCE U.S. Food and Drug Administration
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