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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-19
February 12, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches
Continuing Investigation Identifies Three More Suspect Websites

FDA has taken action against three foreign internet sites associated with a site previously found to be selling counterfeit contraceptive patches that contain no active ingredients. These counterfeit patches provide no protection against pregnancy.

The three newly discovered internet sites involved are www.usarxstore.com, www.europeanrxpharmacy.com, and www.generic.com. These sites also sold other drugs that purported to be the same as FDA-approved drugs, but are in fact from unknown sources and of unknown safety and efficacy. To protect the public health FDA has obtained the cooperation of the U.S.-based internet service provider in shutting down service to these sites.

This action follows similar action FDA took last week against, www.rxpharmacy.ws which sold counterfeit contraceptive patches as well as other products that purport to be versions of FDA-approved drugs.

FDA urges consumers to treat any drugs purchased from these websites suspect, and not to be considered safe or effective. Copies of the homepages for these now inactive websites are attached as information. Consumers who have products purchased from any of these websites should not use them, but instead contact their healthcare providers immediately.

“We are continuing our efforts to do all we can to protect Americans from unsafe and counterfeit drugs purchased from illegal foreign sites,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “The scope and severity of this case illustrates the serious risks people face when they buy illegal internet drugs.”

The counterfeit contraceptive patches were promoted as Ortho Evra transdermal patches, which are FDA approved, and made by Ortho-McNeil Pharmaceutical, Inc.

Instead customers receive packages of patches without the active ingredient necessary to make the patches effective. Moreover, the counterfeits were sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dating or any other labeling information needed to safely and effectively use this prescription product. Details of the differences between the counterfeit contraceptive patch and the authentic Ortho Evra contraceptive patch were described in our previous news release, which can be viewed at http://www.fda.gov/bbs/topics/NEWS/2004/NEW01017.html. Photos contrasting the legitimate contraceptive patch with the counterfeit are on display at the FDA’s website: http://www.fda.gov/bbs/topics/news/photos/contraceptive/counterfeit.html.

FDA’s Office of Criminal Investigation is continuing to work with the Department of Homeland Security’s Bureau of Immigration and Custom Enforcement (ICE) Cyber Crimes Center to combat pharmaceutical counterfeiting and other illegal internet drug sales and take effective action against those responsible. Trafficking in counterfeit, unapproved, adulterated, or misbranded products is a felony violation of the Federal Food Drug, and Cosmetic Act. The criminal investigation is ongoing.

To date no reports of pregnancies linked to the counterfeit contraceptive patch or adverse reactions linked to other suspect pharmaceutical products sold on these sites have been received by FDA. However, the source of the products offered for sale and the safety and efficacy of those products are unknown. Distribution of these suspect products appears limited to the internet, and we cannot be certain that sales are limited to only the four sites identified to date.

Consumers are encouraged to fill prescriptions at reputable pharmacies. Those seeking to buy safe and effective drugs via the internet should only purchase from internet sites bearing the Verified Internet Pharmacy Practice Sites (VIPPS) seal showing that they are in accordance with the National Boards of Pharmacy standards.
 

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