Between September 25 and October 2, 2012, the U.S. Food and Drug Administration (“FDA”), in cooperation and coordination with international law enforcement and regulatory agencies in 100 countries, shut down more than 18,000 illegal Internet pharmacy websites operated by more than 4,100 Internet pharmacies worldwide and seized pharmaceuticals estimated to be valued at approximately $10.5 million.
This year’s efforts were part of the fifth annual International Internet Week of Action, named Operation Pangea V, that combats the online sale and distribution of counterfeit (unapproved) and illegal drugs and medical devices that are potentially dangerous by identifying the producers and distributors of such illegal drugs and medical devices and by removing them from the supply chain.
The illegal and counterfeit drugs that Operation Pangea V focused on included Domperidone, which was removed from the United States market in 1998 because it may cause serious adverse effects, including irregular heartbeat, stopping of the heart, or sudden death (nursing mothers may be using domperidone to try increase milk production, which is an unapproved use); Isotretinoin, which had been previously marketed in the United States as Accutane to treat severe nodular acne but has significant potential risks, including severe birth defects if pregnancy occurs during use of the medication (the FDA has restricted distribution of Isotretinoin-containing medications in the United States); Tamiflu (oseltamivir phosphate), which is an anitiviral medication used to treat the flu, versions of which had been sold illegally online as “generic Tamiflu,” which may contain a false and ineffective active ingredient that is similar to penicillin that may cause a severe allergic reaction, including anaphylaxis, in people allergic to penicillin products; and, Viagra (sildenafil citrate), which is used to treat erectile dysfunction, which should not be used by men with certain heart conditions without proper medical supervision because of potential drug interactions, such as increased blood pressure lowering effects of organic nitrates when taken with sildenafil citrate.
“Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or otherwise unsafe medicines,” said FDA Commissioner Margaret A. Hamburg, M.D. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present.”
“Internet pharmacies that illegally sell unapproved, counterfeit, or potentially adulterated or substandard drugs are an inherently international crime problem,” said John Roth, director of the FDA’s Office of Criminal Investigation. “The FDA is pleased to work with INTERPOL, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs.”
If you, a family member, a loved one, or someone you know may have been injured as a result of a counterfeit drug or a “bad drug,” you should promptly seek the advice of a medical malpractice attorney (“drug attorney”) in your state who may be willing to assist you by investigating your potential drug claim for you and represent you in a “bad drug” case, if appropriate.
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