FDA Continues To Warn About Counterfeit Drugs
The FDA is cautioning consumers about dangers related to purchasing prescriptions over the Internet. This alert is being issued based on information they collected showing that 24 allegedly related Web sites may be involved in the distribution of counterfeit prescriptions.
On three occasions during recent months, FDA received information that counterfeit Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were purchased by 3 consumers from two unrelated Web sites. Xenical is an FDA-approved drug used to assist obese people that meet specific height and weight requirements lose weight and maintain weight loss. These capsules ordered from the website didn't contain 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 drug is also used to help people lose and maintain weight loss, it is not intended for people in specific patient profiles and should not be substituted for other weight loss drugs.
In addition, the drug interactions profile vary between Xenical and sibutramine, as is dosage frequency; sibutramine is administered once a day while Xenical is dosed talc and starch. Roche stated, these samples were marked with 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. Roche identified the two indicated in this incident as brandpills.com and pillspharm.com.
Further investigation by FDA concluded that these Web sites are two of twenty-four Web sites that are posted on the pharmacycall365.com home page under 'websites" heading. Four of these Web sites had been previously identified by FDA's Office of Criminal Investigations as related to the distribution of counterfeit Cialis and Tamiflu.
At this point, it appears that these Web sites are being operated from outside of the US. Consumers should be concerned, if there is no way to communicate with the website pharmacy by phone, if prices are dramatically lower than the competitor's, or if no prescription from your doctor is required. FDA strongly cautions the public regarding purchasing 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.
Published July 28th, 2008
Filed in Health