A leader of the Food and Drug Administration's drug-safety office has told Congress that the agency and its once-vaunted Center for Drug Evaluation and Research are “broken.” The FDA is currently the object of several investigations, including one initiated at its own request.
A Consumer Reports investigation has now found that tens of millions of people may unknowingly have been exposed to the rare but serious side effects of a dozen relatively common prescription-drug types. Collectively, the drugs, sold in 140 brand-name or generic versions, accounted for some 266 million prescriptions in the U.S. and almost $25 billion in sales during the 12 months ending in September 2005, according to NDCHealth, an Atlanta-based health-care-information company.
But their known or possible adverse effects--which include heart attack, stroke, kidney failure, irreversible bone loss, and cancer--were undetected or underestimated when the FDA approved them for use. Some still don't carry a black-box warning--the most serious label alert--that our chief medical adviser says they should.
Even a perfect drug-safety system might miss some of the adverse effects of medicines before they hit the market. But our investigation has identified serious flaws in both the initial drug-approval process and the monitoring of products after they reach the market, which have almost surely delayed the detection and public disclosure of adverse reactions of many widely sold medications. Indeed, our investigation suggests that our list of 12 is not exhaustive.
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 & MAJOR USE:
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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