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>FDA Test Results of Prescription Drugs from Bogus >Canadian Website Show All >Products Are Fake and Substandard > >A Food and Drug Administration (FDA) analysis of three >commonly prescribed >drugs purchased from a Web site advertised as Canadian >showed that so-called >"Canadian Generics" bought from the Web site were >fake, substandard and >potentially dangerous. One was a controlled substance. >In light of these >findings, FDA reiterates its strong concerns about >purchasing prescription >drugs online from unknown sources. > >FDA investigators recently purchased three commonly >prescribed drugs from a >Web site advertising "Canadian Generics," which had >been sending "spam" >emails promoting its products. The products purchased >were so-called >"generic" versions of Viagra, Lipitor, and Ambien. >None of the three >products has a U.S.-approved generic version, and so >all three drugs were >unapproved. > >"The test results of our analyses offer proof positive >that buying >prescription drugs online from unknown foreign sources >can be a risky >business. As was the case here, even where a website >looks legitimate, FDA >has clear evidence that the Web site is dispensing >misbranded drugs that are >not the same quality as those approved by the FDA for >sale in the United >States. Consumers who believe they are getting >equivalent products from >reputable sources are being misled and putting their >health at risk," said >FDA Acting Commissioner Dr. Lester M. Crawford. "This >firm shipped drugs >that were the wrong strength, including some that were >substantially >super-potent and that pose real health risks as a >result, drugs that didn't >dissolve properly, drugs that contained contaminants, >and drugs that should >not have been given because of potentially dangerous >drug interactions." > >Ambien, a controlled substance (schedule IV), is >approved for the short-term >treatment of insomnia in the U.S. The product FDA >obtained online contained >too much active ingredient, including one tablet that >was nearly double the >labeled potency. Taking "superpotent" Ambien puts >patients at risk for >central nervous system depression, especially in >elderly or debilitated >patients. > >The so-called "generic" Lipitor FDA purchased was >subpotent and failed >standard dissolution tests, providing on average only >57 percent of the >active ingredient claimed on the label. It also failed >FDA's purity testing. >Clinically, subpotent product could present a >long-term risk for the various >complications of high cholesterol, such as heart >disease. In addition, the >so-called "generic" Lipitor product was furnished to >FDA's online purchaser, >even though the purchaser said that he was taking the >antibiotic >Erythromycin. Lipitor's label warns against taking >Lipitor and Erythromycin >at the same time. > >Viagra is sold in the U.S. to treat impotence. The >so-called "generic" >version of this product also contained too little of >the active ingredient, >failed the dissolution test, and had an unacceptable >level of impurities. >Although subpotent "generic" Viagra may not place >patients at additional >risk, the purchaser informed the firm in its on-line >questionnaire that he >was taking Erythromycin. Use of Viagra in patients >taking Erythromycin is >contraindicated. > >FDA continues to advise patients and consumers that >they must use great care >when purchasing prescription drugs online. Our >evidence indicates that >although a Web site may appear to be hosted by a >reputable source and may >look similar to other retail pharmacy Web sites, many >of these sites in fact >operate from outside the United States and are >providing unapproved drugs >from unreliable sources. The National Association of >Boards of Pharmacy >(NABP) has established a program called VIPPS designed >to certify Web sites >that meet industry standards. The Agency believes that >consumers should look >for participation in this type of certification >program as one method to >help minimize the risks of getting bad quality drugs >from disreputable >sources.

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