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The Food and Drug Administration is cautioning consumers about dangers related to purchasing prescription over the Internet. This alert is being issued comes from data the agency received showing that 24 allegedly connected Internet sites are probably 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 purchased by three customers from two different Internet sites. Xenical is an FDA-approved drug used to assist overweight individuals that meet specific height and weight requirements lose weight and retain weight loss. None of the capsules ordered 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 is not intended for people in certain patient populations and therefore is not a substitute for other weight loss drugs.

Additionally, the drug interactions profile vary between Xenical and sibutramine, as is dosage frequency; sibutramine is administered once daily while Xenical three times daily. Other drugs obtained from two of the Internet orders were composed of only contained only talc and starch. Roche stated, these two samples were marked with 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 brandpills.com and pillspharm.com.

Further investigation by FDA concluded that these websites are two of 24 websites that appear on the pharmacycall365.com home page under 'websites" heading. Four of these websites previously have been 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 seems as though these websites are operated from outside of the United States. Consumers should be skeptical, if there is no way to communicate with the website pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription is required. As a result, FDA strongly cautions the public regarding the purchase of pharmaceuticals from any of these websites which may be connected to the distribution of fake drugs and continues to warn the public about buying prescription drugs online.