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An FDA Warning about Counterfeit Drugs Sold on the Internet The Food and Drug Administration (FDA) is cautioning U.S. consumers based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs. The FDA received information that three consumers obtained counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche, from two different Web sites. Xenical is an FDA-approved drug used to help obese people lose weight. None of the capsules ordered from the internet contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories. Subutramine is also used to help people lose weight but it should not be used in certain patient populations. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day. Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two 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. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at www.fda.gov/bbs/topics/news/photos/xenical.html. Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the "Our Websites" heading. Four of these Web sites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis. At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online. Consumers are urged to review the FDA Web page at http://www.fda.gov/oc/buyonline/default.htm for additional information prior to making purchases of prescription drugs over the Internet. The 24 Web sites appear on pharmacycall365.com.
NeedyMeds advises consumers to look for the VIPPS seal (Verified Internet Pharmacy Practice Sites) on websites selling medicines. VIPPS is a program of the National Association of Boards of Pharmacy. To be VIPPS accredited, a pharmacy must comply with the licensing and inspection requirements of their state and each state to which they dispense pharmaceuticals. This seal, seen below, is usually at the bottom of the homepage and should be a hotlink to the Boards of Pharmacy site. Once there the original site can be verified. 
Created May 16, 2007 |