FDA Continues To Warn About Counterfeit Drugs
The Food and Drug Administration is warning the U.S. citizens about risks related to purchasing prescription over the Internet. This warning is being issued comes from data the agency collected showing that 24 allegedly related Web sites are probably responsible for the dispensing of counterfeit prescriptions.
On three occasions 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 3 consumers from two unrelated Web sites. Xenical is an FDA-approved drug used to assist obese individuals who meet certain height and weight requirements lose weight and maintain weight loss. These capsules ordered from the website did not 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 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 is not intended for people in certain patient populations and therefore is not a substitute for other weight loss products.
In addition, the drug interactions profile vary between Xenical and sibutramine, as is dosage frequency; sibutramine is administered once daily while Xenical three times a day. Other drugs procured from two of the Website orders were composed of only contained only talc and starch. Roche stated, these two 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 involved in this incident as pilspharm and brandpills.com.
Further research by FDA disclosed that these websites are two of twenty-four websites that are posted on the pharmacycall365.com homepage under ‘websites” heading. Four of these websites had been previously identified by FDA’s Office of Criminal Investigations as being associated with the distribution of counterfeit Cialis and Tamiflu.
It seems as though these websites are being operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by telephone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. FDA strongly cautions the public about the purchase of pharmaceuticals from any of these websites which may be connected to the distribution of fake drugs and reiterates previous public warnings about buying prescription drugs online.
- CF Thompson
:: Aug.04.2008 :: Health :: No Comments »
