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FDA Warns that Mexican Drugs May Be Counterfeit

May 13, 2005
The Food and Drug Administration (FDA) is warning consumers 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.

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Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately.

Counterfeit versions of Lipitor (a cholesterol-lowering drug), Viagra (a treatment for erectile dysfunction), and Evista (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 warns 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.

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