Counterfeit drug warning

FDA Consumer, July-August, 2005

The FDA warns that counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" are being sold 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 health care provider immediately.

Counterfeit versions of the cholesterol-lowering drug Lipitor; Viagra, a treatment for erectile dysfunction; and Evista, a treatment and prevention medication for osteoporosis in post-menopausal women, can pose significant risks. The counterfeit products were analyzed and found to contain no active ingredient.

Counterfeit Lipitor that contains no active ingredient could present a long-term risk for the various complications of high cholesterol, such as heart disease. Counterfeit Viagra that contains little or no active ingredient would be less effective, or altogether ineffective, compared with the legitimate product. 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 purchased from Agua Prieta, Sonora, Mexico. It is labeled as "Raloxifeno, fenilox, 50 tabletas, 60 mg.," made or distributed by Litio and labeled as manufactured in Monterrey, Nuevo Leon, Mexico. The label has red triangles across the top and bottom. The counterfeit Lipitor and Viagra were purchased in Juarez, Los Algodones, Nogales, and Tijuana. The products were labeled only in English, whereas legitimate Mexican pharmaceuticals are usually labeled in Spanish. The counterfeit Lipitor was provided in round, white plastic bottles, but authentic Lipitor in Mexico is sold in boxes of blister packs.

The FDA warns 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.

For more consumer information about counterfeit drugs, visit the following Web sites:

Counterfeit drug photographs: www.fda.gov/bbs/topics/news/photos/border.html

FDA consumer education for counterfeit medicine: www.fda.qov/cder/consumerinfo/counterfeittext.htm

To report suspected counterfeit drugs: www.fda.qov/medwatch