Beware of Illegally Sold Diabetes TreatmentsU.S. Food & Drug Administration (FDA) sent this bulletin at 07/23/2013 11:28 AM EDT Receive this email from someone else? Subscribe now!
07/23/2013 10:00 AM EDT
Consumers with diabetes risk serious health complications by choosing illegally sold products that promise to prevent, treat or even cure diabetes. In addition to making unproven claims, they may also be dangerous in and of themselves.
Read this Consumer Update to learn about the unapproved products flooding the marketplace and what the FDA is doing to counter diabetes products that violate federal law.
Beware of Illegally Sold Diabetes Treatments
Sound too good to be true? Then it's probably a scam. Watch out for these and similar red flags:
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The Food and Drug Administration (FDA) is advising consumers not to use such products. They may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter (OTC) products when they should be marketed as prescription products. They carry an additional risk if they cause consumers to delay or discontinue effective treatments for diabetes. Without proper disease management, people with diabetes are at a greater risk for developing serious health complications.
"People with chronic or incurable diseases may feel desperate and become easy prey. Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than exposing patients to unproven and risky products," said Gary Coody, R.Ph., national health fraud coordinator for FDA. "Failure to follow well-established treatment plans can lead to, among other things, amputations, kidney disease, blindness and death."
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In July 2013, FDA issued letters warning 15 companies about selling products for diabetes in violation of federal law. These products are sold as dietary supplements; alternative medicines, such as ayurvedics; prescription drugs and over-the-counter drugs, including homeopathic products: Examples of claims observed on these illegally marketed products include:
- "Lower your blood sugar naturally."
- "Lowers A1C levels significantly."
- "You'll lower your chances of having eye disease, kidney disease, nerve damage and heart disease!"
- "It can replace medicine in the treatment of diabetes."
- "For Relief of Diabetic Foot Pain."
FDA tested products marketed as "all natural" treatments for diabetes and discovered some of them contained one or more active ingredients found in prescription drugs to treat type 2 diabetes.
Undeclared ingredients can cause serious harm. If consumers and their health care professionals are unaware of the actual ingredients in the products they are taking, these products may interact in dangerous ways with other medications. One possible complication: Patients may end up taking a larger combined dose of the diabetic drugs than they intended, and that may cause a significant unsafe drop in blood sugar levels, a condition known as hypoglycemia.
FDA also looked at sales of prescription drugs from fraudulent online pharmacies. Signs that indicate an online pharmacy is legitimate include: requiring that patients have a valid prescription; providing a physical address in the U.S.; being licensed by a state pharmacy board; and having a state-licensed pharmacist to answer questions. Some fraudulent online pharmacies illegally sell drugs that are not approved in the United States, or sell prescription drug products without meeting necessary requirements.
One website that is subject to a warning letter shipped a prescription diabetes drug without requiring a prescription, and even included an unsolicited free sample of a prescription drug for erectile dysfunction. Moreover, the prescription diabetes drug was dispensed without the medication guide and other precautions required by FDA to ensure the drug is used safely and appropriately.
Although some of these websites may offer for sale what appear to be FDA-approved prescription drugs, FDA cannot confirm that the manufacture or the handling of these drugs follows U.S. regulations or that the drugs are safe and effective for their intended uses. Also, there is a risk the drugs may be counterfeit, contaminated, expired or otherwise unsafe.
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Centers for Disease Control and Prevention. Millions more have pre-diabetes, meaning they have higher than normal blood sugar levels and can reduce their risks of developing diabetes through healthy lifestyle changes, including diet and exercise.
"Products that promise an easy fix might be alluring, but consumers are gambling with their health. In general, diabetes is a chronic disease, but it is manageable and people can lower their risk for developing complications by following treatments prescribed by health care professionals, carefully monitoring blood sugar levels, and sticking to an appropriate diet and exercise program," said Coody.
Health care professionals and consumers are encouraged to report any adverse events related to products intented to treat or cure diabetes to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- online at www.fda.gov/Medwatch/report.htm;
- by phone at 800-FDA-1088 (800-332-1088); or,
- by returning FDA form 3500, available on the MedWatch "Download Forms" page by mail to the address on the pre-addressed form or by fax at 800-FDA-0178.
July 23, 2013
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For More Information
- Illegally Sold Diabetes Treatments - Main Page
- Tratamientos para la diabetes que se venden ilegalmente
- BeSafeRx: Know Your Online Pharmacy
- Health Fraud Scams
- CDC Diabetes Public Health Resource
- NIH Diabetes Information Clearinghouse
- Buying Health Products and Services Online
- Fraud Alert for People with Diabetes
- Cyber Letters 2013