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    Barnum Was Right: FDA Finds Online Drug Purchases Don’t Even Save Consumers Money

    July 2, 2007
    We probably didn't need a reminder on this point.  (After all, I've just received my 10th email in two working days from the "United States National Medical Association," sworn to protect the safety of U.S. consumers buying drugs online) ... but some people do, and FDA just issued this alert on the risks of buying pharmaceuticals online. As the statement notes, this dangerous practice doesn't even save consumers money (Tables 1 and 2 summarize top potential online drug risks, FDA notes that generic forms of these drugs are readily available at low cost). Buying Drugs Online Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing New data collected by the FDA 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. 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. 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 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) http://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)   http://www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor (August 31, 2005) http://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) http://www.fda.gov/bbs/topics/news/2004/NEW01142.html FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (July 30, 2004) http://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) http://www.fda.gov/bbs/topics/news/2004/NEW01087.html FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches (February 12, 2004) http://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)   http://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)   http://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
    We probably didn't need a reminder on this point.  (After all, I've just received my 10th email in two working days from the "United States National Medical Association," sworn to protect the safety of U.S. consumers buying drugs online) ... but some people do, and FDA just issued this alert on the risks of buying pharmaceuticals online. As the statement notes, this dangerous practice doesn't even save consumers money (Tables 1 and 2 summarize top potential online drug risks, FDA notes that generic forms of these drugs are readily available at low cost). Buying Drugs Online Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing New data collected by the FDA 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. 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. 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 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) http://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)   http://www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor (August 31, 2005) http://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) http://www.fda.gov/bbs/topics/news/2004/NEW01142.html FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (July 30, 2004) http://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) http://www.fda.gov/bbs/topics/news/2004/NEW01087.html FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches (February 12, 2004) http://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)   http://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)   http://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
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