FDA Shutters Illegal Online Pharmacies with Criminal Ties
In partnership with international regulatory and law enforcement agencies, the U.S. Food and Drug Administration took action this week against more than 9,600 websites that have been illegally selling potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, as well as seizure of offending websites and more than $41 million 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, dubbed Operation Pangea VI, the FDA's Office of Criminal Investigations, in coordination with the U.S. Attorney's Office for the District of Colorado, seized and shut down 1,677 illegal pharmacy websites. The joint effort ran from June 18 to June 25.
Fake Drugs, Fake Claims
The FDA said many of the 1,677 Web sites appeared to be operating as a part of an organized criminal network that falsely purported its Web sites to be "Canadian Pharmacies."
These Web sites 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.
The Web sites in question also used certain major U.S. pharmacy retailer names to trick U.S. consumers into believing an affiliation existed with these retailers.
"Illegal online pharmacies put American consumers' health at risk by selling potentially dangerous products. This is an ongoing battle in the United States and abroad, and the FDA will continue its criminal law enforcement and regulatory efforts," said John Roth, director of the FDA's Office of Criminal Investigations.
"The agency is pleased to participate in Operation Pangea to protect consumers and strengthen relationships with international partners who join in this fight."
The FDA provided a list of some of the medicines that were sold illegally by the websites targeted during Operation Pangea VI, including the following details:
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.
In addition to health risks, the FDA warns the illegally operating pharmacies pose non-health-related risks to consumers, including the possible exposure to credit card fraud, identity theft, and computer viruses.
The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci.
The FDA provides consumers with information to identify an illegal pharmacy website and advice on how to find a safe online pharmacy through BeSafeRx: Know Your Online Pharmacy.