FDA Says Foreign Drugs Bought on Internet May Be More Expensive, Risky

July 13, 2007 - The Food and Drug Administration continues to warn the American public about the dangers of buying medications over the Internet. New FDA data show that consumers who are trying to save money on prescription drugs don’t need to take chances by buying prescription drugs from foreign Internet sites, because low-cost generic versions are available in the United States, according to an FDA press release.

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This finding also may be an indication that some consumers are likely buying foreign drugs this way to avoid getting a prescription from their doctor or health care professional, since many Web sites do not require a prescription, according to the FDA.

Safety Concerns

The use of prescription drugs without a prescription is an intrinsically unsafe practice. FDA urges consumers to have a prescription from their doctor or other health care professional before using prescription drugs. The agency also urges consumers to review www.fda.gov for important information before making such purchases.

Consumers should be aware of safety concerns of drugs purchased from unregulated Internet sellers since some of these drugs might:

● require careful dosing and monitoring;

● not have adequate labeling for safe use;

● be inappropriately packaged, therefore product integrity is uncertain;

● have been withdrawn from the U.S. market for safety or efficacy reasons;

● may carry risks that require initial screening and/or periodic patient monitoring;

● cause harm—such as a controlled substance (narcotic), whose use should be supervised by a doctor or health care professional due to abuse potential; and

● have clinically significant drug-drug interactions.

Recent examinations of a sample of drugs shipped to U.S. consumers found several drugs are associated with higher risks and are more dangerous to the consumer if used without the supervision of a doctor or health care professional.

For example, warfarin (an anticoagulant or blood thinner) is a medication that requires very close monitoring to prevent stroke or death.

Another example is amoxicillin and other antibiotics that should not be used for self treatment to reduce the risk of antibiotic-resistant infections.

Levothyroxine, a thyroid replacement hormone, also requires close monitoring to ensure effective treatment. Another blood thinner, clopidogrel, may pose increased risk of cardiac events, such as heart attack if used in sub-optimal doses, which might be found in imported tablets. (See more examples in Table 2).

Consumers are also at risk if the drugs are not properly labeled for safe and effective use. For example, alendronate sodium, which is used to treat and prevent osteoporosis, should include information warning patients of significant side effects if it is not taken appropriately.

Imported eye drop preparations may not have been manufactured under proper conditions to ensure sterility, leaving patients susceptible to contamination that may result in serious infections. These are only a few examples demonstrating the importance of obtaining FDA-approved drugs and health care provider monitoring.

Cost Concerns

The examination of foreign mail shipments also found that about 45 percent of the imported products already are available in the United States as an FDA-approved generic drug (see Table 1). About half of these generic drugs are available through national pharmacy chain programs that offer generic prescriptions at a cost of $4 each. This cost is usually significantly less than the cost of drugs charged by Internet sellers.

FDA has documented problems with imported drug products and has taken action when possible against foreign Web sites selling counterfeit products. Some examples follow.

● FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips (October 23, 2006)
www.fda.gov/bbs/topics/NEWS/2006/NEW01497.html

● FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products (August 30, 2006)
www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html

● Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor (August 31, 2005)
www.fda.gov/bbs/topics/news/2005/new01228.html

● FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs (December 01, 2004)
www.fda.gov/bbs/topics/news/2004/NEW01142.html

● FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (July 30, 2004)
www.fda.gov/bbs/topics/ANSWERS/2004/ANS01303.html

● FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard (July 13, 2004)
www.fda.gov/bbs/topics/news/2004/NEW01087.html

● FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches (February 12, 2004)
www.fda.gov/bbs/topics/NEWS/2004/NEW01023.html

● FDA and Johnson & Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site (February 04, 2004)
www.fda.gov/bbs/topics/NEWS/2004/NEW01017.html

● FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially Dangerous Imported Drug Shipments (September 29, 2003)
www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html

TABLE 1: Examples of intercepted drugs available as low-cost generic products in the U.S.
Drug Product	Common Intended Medical Use
Amoxicillin Capsules	Antibiotic
Atenolol Tablets	High blood pressure
Fluoxetine Capsule	Depression
Hydrochlorothiazide (HCTZ) Tablets	High blood pressure (diuretic)
Isotretinoin Capsules	Oral anti-acne
Levothyroxine Tablets	Thyroid hormone replacement
Lisinopril Tablets	High blood pressure
Meloxicam Tablets	Inflammation
Metformin Tablets	Diabetes (blood sugar levels)
Metoprolol Tartrate Tablets	High blood pressure
Methotrexate Tablets	Anti-cancer
Nifedipine ER (extended release) Tablets	High blood pressure
Paroxetine Tablets	Depression
Phenytoin Capsules	Anti-seizure
Prednisone Tablets	Inflammation (steroid)
Simvastatin Tablets	High cholesterol
Tamoxifen Tablets	Anti-cancer
Warfarin Tablets	Blood thinner

TABLE 2: Examples of intercepted drugs with particular associated risks
Drug Product	Common Intended Medical Use
Alendronate sodium Tablets	Osteoporosis
Amoxicillin Capsules	Antibiotic
Celecoxib Capsules	Osteo- and Rheumatoid Arthritis
Clopidogrel Tablets	Blood thinner
Isotretinoin Capsules	Oral anti-acne
Levothyroxine Tablets	Thyroid hormone replacement
Methotrexate Tablets	Anti-cancer
Prednisone Tablets	Inflammation (steroid)
Phenytoin Capsules	Anti-seizure
Warfarin Tablets	Blood thinner
Zolpidem Tablets	Insomnia

To see a consumer article called The Possible Dangers of Buying Medicine Online, visit www.fda.gov/consumer/features/drugsonline0707.html.

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