Thousands of Internet Pharmacies Targeted by FDA Legal Actions

International law enforcement agencies have taken civil and criminal actions to shut down more than 4,100 internet pharmacies distributing unapproved and potentially dangerous medicines to the United States.

The U.S. Food and Drug Administration (FDA) operated with INTERPOL, the international police agency, to form Operation Pangea V, which was conducted between September 25 and October 2, according to an FDA press release issued this week.

The purpose of the international operation was to target and eliminate the illegal sale and distribution of drugs and medical devices, which may pose a serious and potentially deadly risks to consumers within the United States.

Efforts of Operation Pangea V resulted in the shutdown of more than 18,000 illegal pharmacy websites and law enforcement officials seized roughly $10.5 million worth of medications and devices worldwide.

The medicines being illegally distributed to consumers in the U.S. may pose a serious risk because the products may contain active ingredients that are either approved by the FDA only under a licensed health practitioner’s supervision or were previously withdrawn for the U.S. market due to health hazards.

Last week, the FDA announced a new initiative aimed at educating Americans about the risks associated with ordering medications from an on-line pharmacy.

Medications seized in the enforcement operation include:

• Doperdine: A medicine removed from the U.S. market in 1998 because of the potential risks of irregular heartbeat, stopping of the heart, or sudden death. The medication caused risk for women breast feeding because the purpose of the drug was to enhance milk production (which was not an approved use).
• Accutane: A medicine used for the reduction of acne, which may carry a risk of birth defects in pregnant women using the medication. It has also been linked to an increased risk of inflammatory bowel syndrome. This drug is only available in the U.S. through restricted distribution.
• Tamiflu: This medicine was used to treat the flu and is often sold online as “generic Tamiflu”; however the FDA does not have an approved form of this medication for the market. Many fraudulent brands have active ingredients that do not counteract the flu such as penicillin, which if a consumer is not aware they are allergic to may cause severe allergic reaction and potential life threatening injuries.
• Viagra: This medication is used to treat erectile dysfunction, but due to its vasodilatation effects, it should not be used without the supervision of a health care professional. Side effects can include rapid increase in blood pressure and lowering the effects or organic nitrates.

The FDA has sent warning letters to the operators of more than 4,100 identifiable websites and has provided notices to Registries, Internet Service Providers, and Domain Name Registars informing them that the websites were selling products in violation of U.S. law.

As the FDA works closely with INTERPOL to eliminate criminal distribution of pharmaceuticals, they encourage consumers that may have taken these medications without the supervision of health care practitioner report to one. Also the FDA is encouraging consumers to report suspected criminal activity to www.fda.gov/oci³.