he 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 (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 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:
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From the U.S. FDA
May 10, 2005
http://origin.www.fda.gov/bbs/topics/ANSWERS/2005/ANS01357.html
