Counterfeit drugs from Mexico dupe cross-border bargain hunters

Drug Store News, August 23, 2004 by Michelle L. Kirsche

WASHINGTON -- Consumers who thought they were buying a popular prescription medication from a Mexican border-town pharmacy instead received a phony with no active ingredients.

According to a report issued July 30 by the U.S. Food and Drug Administration, counterfeit versions of Merck s blockbuster cholesterol medication Zocor (simvastatin), as well as carisoprodol, a genetic muscle relaxer, were imported from Mexico by Americans looking for cheap prescription drugs.

Tests on the drugs, however, showed the counterfeit Zocor did not contain any active ingredients, and the counterfeit carisoprodol differed in potency compared with the authentic product. The drugs were sold under the names Zocor 40 mg (lot number K9784, expiration date November 2004), and Carisoprodol 350 mg (lot number 68348A).

The findings prompted the FDA to speak out against Americans buying drugs from foreign countries. "As demonstrated by this incident, purchasers cannot assume that the products meet the quality, efficacy and safety standards of FDA-authorized products, or that the FDA is assuring the quality, safety and efficacy of products purchased from outside the United States," the agency stated.

A spokesman for Merck told Drug Store News that the pharmaceutical company currently is working with Mexican and U.S. authorities to investigate. At this time, he said, the company has not identified any additional Mexican border pharmacies selling phony versions of the drug. He declined, however, to comment on whether the company is piloting any programs using radio frequency identification technology to help prevent drug counterfeiting.

According to IMS Health, Zocor generated U.S. sales in 2003 totaling $4.386 billion, with 29.4 million prescriptions dispensed. The drug is scheduled to lose its patent protection in 2006.

And while the fake Zocor incident proves border pharmacies are still dealing in counterfeit drugs, Internet pharmacies have received the bulk of the publicity in the debate over drug importation.

On July 13, the FDA reported that three commonly prescribed drugs purchased from a Canadian Web site--sold as generic versions of the erectile dysfunction drug Viagra (sildenafil citrate, Pfizer), the cholesterol-lowering drug Lipitor (atorvastatin, Pfizer) and the sleep aid Ambien (zolpidem tartrate, Sanofi-Synthelabo)--were either fake, substandard and/or potentially dangerous. The drugs were sold as "generic" versions, despite none of them having an approved generic version in the United States.

As a direct response, in the first week of August, Pfizer launched a public awareness campaign instructing how to avoid illegitimate Web sites, how to safely purchase genuine Viagra online and how to minimize spam e-mails touting cheap Viagra.

According to Pfizer, 16 million men around the world have taken Viagra, with nine tablets dispensed every second on a worldwide basis.