FDA concerns about the safety of prescription drug imports were underscored by the agency's discovery of a Canadian Internet site marketing bogus "generic" versions of a number of topselling single-source drugs. The products promoted on the Web site as "Canadian generic" versions of Lipitor, Viagra, and Ambien are actually "fake, substandard, and potentially dangerous," an FDA official said following a laboratory analysis of prescription drugs purchased from the on-line vendor.
"The test results of our analyses offer proof positive that buying prescription drugs on-line from unknown foreign sources can be a risky business," said FDA Acting Commissioner Lester M. Crawford, DVM, PhD.
The Ambien tablets turned out to be superpotent, putting "patients at risk for central nervous system depression," whereas so-called "generic Lipitor" tested out to be subpotent, containing only 57% of the necessary active ingredient. The fake Viagra sold on the Web site also contained too little of the active ingredient, failed the dissolution test, and had an unacceptable level of impurities, the FDA official said.
"Consumers who believe they are getting equivalent products from reputable sources are being misled and putting their health at risk" when they order prescription medicines from unknown sources, Crawford warned. "This firm shipped drugs that were the wrong strength, including some that were substantially superpotent 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."
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