Counterfeit Lipitor, Viagra, and Evista Sold in Mexican Border Towns

FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico

The Food and Drug Administration (FDA) is warning the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" to U.S. consumers at pharmacies in Mexican border towns.

Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately. FDA is warning consumers that prescription drugs purchased in foreign countries are not regulated by the FDA and do not carry the same FDA assurances of safety, effectiveness, and manufacturing quality as drugs purchased within the United States.

Counterfeit versions of Lipitor (atorvastatin) (a cholesterol-lowering drug), Viagra (sildenafil) (a treatment for erectile dysfunction ), and Evista (raloxifene) (a treatment and prevention medication for osteoporosis in postmenopausal women) can pose significant risks to consumers. Counterfeit Lipitor that contains no active ingredient or not enough active ingredient could present a long-term risk for the various complications of high cholesterol , such as heart disease. The counterfeit product purchased in Mexico was associated with several reports of high cholesterol in consumers who had used the product. Counterfeit Viagra that contains little or no active ingredient would be less effective than a legitimate product or altogether ineffective. Women who take the substandard generic Evista product that contains no active ingredient may be at risk for developing osteoporosis or for having their osteoporosis progress.

The "generic Evista" was analyzed by FDA in coordination with the National Association of Boards of Pharmacy and was found to contain no active ingredient. The counterfeit Lipitor and counterfeit Viagra were analyzed by Pfizer, Inc. and were also found to contain no active ingredient.

The "generic Evista" product was purchased from Agua Prieta, Sonora, Mexico and is labeled as "Raloxifeno, fenilox, 50 tabletas, 60mg", made or distributed by Litio and labeled as manufactured in Monterrey, Nuevo Leon, Mexico. The label has red triangles across the top and bottom. (See the website noted below for photographs of the products.)

Counterfeit Lipitor and Viagra were purchased in the Mexican border towns of Juarez, Los Algodones, Nogales, and Tijuana . The counterfeit Lipitor and counterfeit Viagra products were labeled only in English, whereas legitimate Mexican pharmaceuticals are usually labeled in Spanish. In addition, the counterfeit Lipitor was provided in round white plastic bottles; however authentic Lipitor in Mexico is sold only in boxes of blister packs.

FDA and Mexican federal health officials are continuing to work together to address the issue of counterfeit human drug products, especially along our common border. Recently, federal health officials in Mexico's Federal Commission for the Protection from Sanitary Risks (COFEPRIS) have undertaken several specific operations to target illegal drugs, including counterfeit drugs, in Mexican drug stores. These operations, throughout Mexico, including the areas that border on the U.S. have resulted in the suspension of 19 pharmacies and the confiscation and recall of over 105 tons of medicines.

Reports of suspected counterfeit drugs can be submitted to FDA at http://www.fda.gov/medwatch.

For additional consumer information on counterfeit drugs, visit the following websites:

Source: FDA Talk Paper T05-20, May 10, 2005
Last Editorial Review: 5/11/2005




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