The Food and Drug Administration is cautioning the public about dangers related to purchasing prescription over the Internet. This alert is being issued comes from information they collected demonstrating that 24 allegedly connected Web sites are probably responsible for the distribution of counterfeit prescriptions.

Three times during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were purchased by 3 customers from two unrelated Web sites. Xenical is an FDA-approved drug utilized to assist overweight individuals that meet particular weight and height requirements lose weight and retain weight loss. These capsules purchased from the website didn't have the active ingredient 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 product is also used to lose and maintain weight loss, it is not intended for people in certain patient populations and therefore is not a substitute for other weight loss drugs.

In addition, the drug interactions profile vary between Xenical and sibutramine, as is dosage frequency; sibutramine is administered once daily while Xenical is dosed 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. Roche identified the two indicated in this incident as pilspharm and brandpills.com.

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

At this point, it seems as though these Web sites are operated from outside of the US. Consumers should be concerned, if there is no way to contact the Web site pharmacy by telephone, if prices are dramatically lower 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 fake drugs and continues to warn the public about buying prescription drugs online.

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