FDA Continues to Warn about Counterfeit Drugs

The Food and Drug Administration is warning the public about risks associated with purchasing prescriptions over the Internet. This alert is being issued based on data the agency collected showing that 24 allegedly connected Web sites may be responsible for the distribution of counterfeit prescriptions.

Three times during recent months, The Food And Drug Administration received data that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were purchased by three consumers from two different Web sites. Xenical is an FDA-approved drug used to assist obese individuals that meet certain height and weight requirements lose weight and retain 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 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 product is also used to lose and maintain weight loss, it should not be used in specific patient profiles and should not be substituted 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 daily while Xenical is dosed 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 proper expiration date for this lot number is actually March 2005. The two websites identified as indicated in this incident as brandpills.com and pillspharm.com.

Further investigation by FDA concluded that these websites are two of 24 websites that are posted on the pharmacycall365.com home page under 'websites" heading. Four of these websites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

It seems as though these websites are operated from outside of the United States. Consumers should be skeptical, 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 from your doctor is required. As a result, FDA strongly cautions consumers regarding the purchase of pharmaceuticals from any of these websites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online.