Warning Letters Issued to Illegally Sold Diabetes Treatments

Recently, FDA launched an initiative to counter these illegally sold products aimed at consumers who have diabetes. In addition to evaluating numerous consumer complaints, FDA surveyed the marketplace for illegally sold products promising to treat diabetes and its complications.

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.”

Some of the companies also promote unapproved products for other serious diseases, including cancer, sexually transmitted diseases, and macular degeneration.

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 counterfeited, contaminated, expired or otherwise unsafe.

Source: FDA

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