The FDA is warning consumers about dangers associated with purchasing prescriptions over the Internet. This warning is being issued based on information they collected demonstrating that 24 allegedly connected Internet sites are probably responsible for the dispensing of counterfeit prescriptions.

Three times during recent months, The Food And Drug Administration received information that counterfeit Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were purchased by 3 customers from two unrelated Internet sites. Xenical is an FDA-approved drug utilized to help obese individuals who meet specific weight and height requirements lose weight and maintain weight loss. None of the capsules purchased off 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 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 is not intended for people in certain patient populations and should not be substituted for other weight loss drugs.

Additionally, the drug interactions profile vary between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once a day while Xenical should be taken 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 indicated in this incident as brandpills.com and pillspharm.com.

Additional research by FDA concluded that these Web sites are two of twenty-four Web sites that are posted on the pharmacycall365.com homepage listed under 'websites" heading. Four of these Web sites previously have been identified by Food and Drug Administration's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it seems as though these Web sites are operated from outside of the United States. Consumers should be concerned, if there is no way to contact the website pharmacy by telephone, if prices are significantly less than the competitor's, or if no prescription is required. As a result, FDA strongly cautions the public regarding purchasing 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.