FDA finds new evidence for cross border fakes

Related tags Pharmacology Food and drug administration Pfizer Fda Us

The discovery of a new batch of counterfeit drugs circulating in
the US market adds urgency to ongoing efforts to improve
traceability in the medicines supply chain, and will also lend
weight to arguments against parallel trade in pharmaceuticals,
reports Phil Taylor.

The US Food and Drug Administration (FDA) is warning the public about the sale of counterfeit versions of Pfizer's Lipitor (atorvastatin) and Viagra (sildenafil), and an unapproved product promoted as a generic version of Eli Lilly's Evista (raloxifene) to US consumers at pharmacies in Mexican border towns.

Last February, the FDA issued a final report that identifies ways to combat what it says is the growing public health problem of counterfeit prescription drugs in the US, highlighting technological innovations such as radiofrequency identification (RFID) and other track-and-trace systems. One view is that cross border trade from countries such as Canada and Mexico is serving as a point of entry for counterfeits into the US, and the latest finding will add weight to that argument.

The bootleg Evista was analysed by the FDA and found to contain no active ingredient, noted the agency, which pointed out that women who take the substandard generic Evista product that contains no active agent may be at risk for developing osteoporosis or for having their condition progress.

The counterfeit Viagra and Lipitor were analysed by Pfizer and also found to contain no active ingredient, and the latter product purchased in Mexico was associated with several reports of high cholesterol in consumers who had used it, the FDA added.

The fake Evista product was purchased from Agua Prieta, Sonora, Mexico, and is labelled as "Raloxifeno, fenilox, 50 tabletas, 60mg, " made or distributed by Litio and labelled as manufactured in Monterrey, Nuevo Leon, Mexico.

Meanwhile, the counterfeit Lipitor and Viagra were purchased in the Mexican border towns of Juarez, Los Algodones, Nogales and Tijuana. They were labelled only in English, whereas legitimate Mexican pharmaceuticals are usually marked in Spanish. In addition, the counterfeit Lipitor was provided in round white plastic bottles while the authentic drug in Mexico is sold only in boxes of blister packs.

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