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FDA Cracks Down on Illegal Online Pharmacies

Phony Web sites claim to sell Canadian drugs (June 27)

The FDA, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 Web sites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.

Many of these Web sites appeared to be operating as a part of an organized criminal network that falsely purported its sites to be “Canadian pharmacies.” These Web sites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs it advertised as “brand name” and “FDA-approved.” The drugs received as part of the FDA operation were not from Canada, and were neither brand name nor FDA-approved. These websites also used certain major U.S. pharmacy retailer names to trick U.S. consumers into believing an affiliation existed with these retailers.

The goal of the internet-based action, which involved law enforcement, customs, and regulatory authorities from 99 countries, was to identify the makers and distributors of illegal drug products and medical devices and to remove these products from the supply chain.

Some of the medicines that were offered for sale illegally included:

  • Avandaryl: FDA-approved Avandaryl (glimepiride and rosiglitazone) is used to treat type 2 diabetes and to minimize potential associated risks, including edema caused by fluid retention, worsening the condition of the heart, or heart failure.
  • “Generic Celebrex”: “Generic Celebrex” sold online is not an FDA-approved product. FDA-approved Celebrex (celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis and to manage acute pain in adults.
  • “Levitra Super Force” and “Viagra Super Force”: While Levitra (vardenafil) and Viagra (sildenafil) are FDA-approved medicines used to treat erectile dysfunction (ED), Levitra Super Force and Viagra Super Force are not FDA-approved products and claim to contain dapoxetine. The FDA has not determined the safety or efficacy of dapoxetine.
  • Clozapine: FDA-approved Clozaril (clozapine) is used to treat severe schizophrenia and is associated with potentially fatal agranulocytosis, a severely low (and dangerous) white blood cell count that can predispose patients to serious, life-threatening infections.

Source: FDA; June 27, 2013.

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