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The FDA is warning the public about dangers associated with buying prescriptions over the Internet. This warning is being issued based on data the agency collected demonstrating that 24 apparently connected Web sites may be involved in the dispensing of counterfeit prescriptions.

Three times during recent months, FDA received data that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three customers from two different Web sites. Xenical is an FDA-approved drug used to assist obese people who meet certain weight and height requirements lose weight and maintain weight loss. None of the capsules purchased from the websites had 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 the study 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 specific patient profiles and therefore is not a substitute for other weight loss products.

Additionally, the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once a day while Xenical three times a day. Other samples of drug product bought from two of the Website orders were composed of only contained only talc and starch. Roche stated, 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. Roche identified the two involved in this incident as pilspharm and brandpills.com.

Further investigation by FDA disclosed that these Web sites are two of twenty-four Web sites that appear 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.

It appears that these Web sites are being operated from outside of the US. Consumers should be skeptical, if there is no way to communicate with the website pharmacy by phone, if prices are significantly less than the competitor's, or if no prescription is required. FDA strongly cautions consumers regarding the purchase of pharmaceuticals from any of these Web sites which may be connected to the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online.

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