The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites 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.
The action occurred as part of the 6th 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. As part of this year’s international effort – Operation Pangea VI – the FDA’s Office of Criminal Investigations, seized and shut down 1,677 illegal pharmacy websites.
Many of these websites appeared to be operating as a part of an organized criminal network that falsely purported its websites to be “Canadian Pharmacies.” These websites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs they advertised as “brand name” and “FDA approved.”
The drugs received as part of Operation Pangea 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.
Some of the medicines that were sold illegally by the websites targeted during Operation Pangea VI 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. Avandaryl must be prescribed by a certified healthcare provider and dispensed by a certified pharmacy with a medication guide explaining the potential risks.
“Generic Celebrex”: “Generic Celebrex” sold online is not an FDA-approved product. FDA-approved Celebrex (celecoxib) is a non-steroidal anti-inflammatory product used to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis and to manage acute pain in adults. To minimize the potential associated risks, including gastrointestinal bleeding, heart attack, or stroke, in some people with long term use, Celebrex must be dispensed with a medication guide explaining the potential risks.
“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. People with certain heart conditions should not take ED medicines containing vardenafil or sildenafil. There are also potentially dangerous drug interactions or serious adverse effects with these drugs, such as loss of hearing or vision.
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. To minimize potential risks, consumers who are prescribed FDA-approved Clozaril must be enrolled in a registry that ensures regular monitoring of their blood counts.
The FDA in collaboration with other federal agencies screened drug products received through selected International Mail Facilities during the IIWA. Preliminary findings show that certain drug products from abroad, such as antidepressants, hormone replacement therapies, sleep aids, and other drugs to treat erectile dysfunction, high cholesterol, and seizures were on the way to U.S. consumers.