FOR IMMEDIATE RELEASE
P06-123
August 30, 2006

Media Inquiries:Catherine McDermott, 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products

The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.

FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.

DRUG NAME / USE(S)

LIPITOR / Cholesterol disorders
CRESTOR / Cholesterol disorders
ZETIA (US name) / EZETROL (Canadian name) / Cholesterol disorders
DIOVAN / High blood pressure
HYZAAR / High blood pressure
ACTONEL / Osteoporosis in postmenopausal women
NEXIUM / Gastroesophageal reflux disease (GERD)
CELEBREX / Arthritis-related pain
ARIMIDEX / Breast cancer
PROPECIA / Male-pattern baldness

Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are:
* www.RxNorth.com;
* www.Canadiandrugstore.com;
* www.Rxbyfax.com;
* www.Northcountryrx.com;
* www.Canada-pharmacy.com;
* www.My-canada-pharmacy.com;
* www.NLRX.com;
* www.Canampharmacy.com;
* www.Canada-Meds-For-Less.net; and
* www.Canadian-safe.com

As a general matter, FDA advises consumers to use caution when buying medical products online. Although a website may appear reputable and similar to legitimate retail pharmacy websites, many actually operate from outside the U.S. and provide unapproved drugs from unreliable sources.

For example, in August of 2005, FDA conducted an operation at New York, Miami, and Los Angeles airports which found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with “Canadian pharmacies.” Of the drugs being promoted as “Canadian,” based on accompanying documentation, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit. These results demonstrated that some Internet sites that claimed to be “Canadian” were, in fact, selling drugs of dubious origin, safety and efficacy.

Today’s announcement is consistent with FDA’s earlier message of the dangers posed by such websites and the need for caution on behalf of the public.

Drug counterfeiting is illegal for good reason. Drug counterfeiting defrauds consumers and can expose them to products containing unknown, ineffective, or harmful ingredients. Counterfeit drugs may be toxic or contain doses that are too small to treat a medical condition, or so large that they could endanger the health of the user. Because of the dangers posed by counterfeit drugs, the FDA aggressively investigates all instances of drug counterfeiting.

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