In March, Abbot Pharmaceuticals reported that two instances of counterfeit Vicodin ES had been found, having been purchased on the internet.
Vicodin ES is a combination of hydrocodone bitartrate and acetaminophen, used to relieve moderate to severe pain. It is a Schedule III drug, which requires a prescription to be dispensed, and is deemed to cause moderate or low physical dependence upon abuse. Hydrocodone is a semi-synethnic opioid.
Abbot reports that the counterfeit medications did not containe hydrocodone bitartrate and acetaminophen, but instead contained diclofenac. Diclofenac is a non-steroid anti-inflammatory drug (NSAID).
The diclofenac tablets were packaged in a 10 count blister pack with the markings "F|P" on one side, and that a counterfeit label with misspellings for Vicodin ES had been placed over the diclofenac's label. Actual Vicodin ES tablets are sold in 4 blister cards with 25 tablets on each card intended for hospital use, and are not sold as individual cards.
This is not the only incident of counterfeit medication found on the internet in 2012. The FDA warned that counterfeit versions of Teva's Adderall had been found on the internet. Instead of the active ingredients used to treat ADHD, dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
Law enforcement for counterfeit medicines found online often involve U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI), the Food and Drug Administration's Office of Criminal Investigations (FDA OCI), and the U.S. Postal Inspection Service.
In January, 2011, these three agencies successfully prosecuted a case agasint Shenyang Zhou, a Chinese national, who pleaded guilty to charges of trafficking in counterfeit medications. Zhou sold counterfeit over-the-counter weight-loss medication styled after legitimate medication, "Alli," to victims on the internet using websites and online-auction sites.
These two cases are only drops in the bucket according to Immigration and Customs Enforcement Deputy Director Kumar Kibble. At the Partnership for Safe Medicines 2011 Interchange, he said in his keynote address, "Thousands of websites openly sell unapproved and counterfeit drugs, which is against the law in the U.S. Drugs purchased over the internet and imported into the US are not FDA approved and there is no guarantee that they are safe. They can be packaged to look legitimate, but still be fake.”
The words of Deputy Director Kibble certainly ring true in this case. We’ll be convening representatives from government, the medical community, and consumer groups for discussion and debate of the global counterfeit drug economy again in September for the 2012 Interchange.
Tickets are available for the 2012 Interchange on September 28, 2012 at the National Press Club in Washington D.C. Please note that this year's event is happening a month earlier than last year's Interchange. Early registration tickets are available until August 15, 2012.