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The Food and Drug Administration is cautioning consumers about dangers related to purchasing prescriptions over the Internet. This warning is being issued comes from data they collected showing that 24 allegedly related Web sites are probably involved in the dispensing of counterfeit prescriptions.

On three occasions during recent months, The Food And Drug Administration received data that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were purchased by 3 consumers from two unrelated Web sites. Xenical is an FDA-approved drug used to help obese people who meet specific height and weight requirements lose weight and maintain weight loss. None of the capsules purchased from the websites contained orlistat. This is the active ingredient in authentic Xenical.

In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed| the laboratory annalists at Roche conducted and submitted a report to the Food And Drug Administration confirming that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescriptions manufactured by Abbott Laboratories. While this drug is also used to lose weight and maintain that loss, it should not be used in certain patient populations and should not be substituted for other weight loss products.

In addition, the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical three times a day. Other drugs purchased from two of the Internet orders were composed of only contained only talc and starch. According to Roche, these two samples were marked with a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The proper expiration date for this lot number is actually March 2005. The two Web sites identified as involved in this incident as pilspharm and brandpills.com.

Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com homepage under 'websites" heading. Four of these Web sites previously have been identified by Food and Drug Administration's Office of Criminal Investigations as related to the distribution of counterfeit Cialis and Tamiflu.

It appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to communicate with the Web site pharmacy by phone, if prices are dramatically lower than the competitor's, or if no prescription is required. As a result, FDA strongly cautions consumers about purchasing pharmaceuticals from any of these Web sites which may be involved in the distribution of fake drugs and reiterates previous public warnings about buying prescription drugs online.