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The Food and Drug Administration is cautioning the public about dangers associated with purchasing prescriptions over the Internet. This warning is being issued comes from data the agency received demonstrating that 24 allegedly connected Web sites may be involved in the distribution of counterfeit prescriptions.

Three times during recent months, FDA received data that counterfeit Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were purchased by three customers from two unrelated Web sites. Xenical is an FDA-approved drug utilized to help obese people that meet certain weight and height requirements lose weight and retain 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 FDA 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 help people lose and maintain weight loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products.

Additionally, the drug interactions profile vary between Xenical and sibutramine, as is dosage frequency; sibutramine is administered once daily while Xenical should be taken talc and starch. According to Roche, these samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. The two Web sites identified as indicated in this incident as pilspharm and brandpills.com.

Additional investigation by FDA concluded that these Web sites are two of twenty-four Web sites that are posted on the pharmacycall365.com home page under 'websites" heading. Four of these Web sites had been previously identified by Food and Drug Administration's Office of Criminal Investigations as related to the distribution of counterfeit Cialis and Tamiflu.

At this point, it appears that these Web sites are being operated from outside of the United States. Consumers should be wary, if there is no way to communicate with the Web site pharmacy by telephone, if prices are dramatically lower than the competitor's, or if no prescription is required. As a result, FDA strongly cautions consumers regarding the purchase of pharmaceuticals from any of these Web sites which may be involved in the distribution of fake drugs and continues to warn the public about buying prescription drugs online.