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Outrage of the Month: “Male-Enhancing” Dietary Supplements Were Tainted With Dangerous Drugs

Health Letter, September 2020

By Michael Carome, M.D.


If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

Image: Yeexin Richelle/Shutterstock.com

For years, the Food and Drug Administration (FDA) has repeatedly warned the public about dietary supplements that have been spiked illegally with hidden drugs. Among the drugs most frequently detected by the FDA in such products have been the active ingredients found in prescription medicines for treating erectile dysfunction, such as sildenafil, the active ingredient contained in VIAGRA. These products typically are promoted as containing “all-natural” ingredients for male sexual enhancement.

A recent report published in the June 19, 2020, issue of Morbidity and Mortality Weekly Reports hammered home the dangers of using these illegal supplements. It described an outbreak of severe, potentially life-threatening hypoglycemia (low blood sugar) in 17 men in Virginia who had consumed male sexual enhancement supplement tablets marketed as “V8” in convenience stores in central Virginia. Analysis of the V8 tablets purchased by the men revealed that they contained sildenafil as well as glyburide, a sulfonylurea medication available by prescription under the brand names DIABETA and GLYNASE that is used to treat patients with type 2 diabetes.

The first case, which occurred in August 2019, involved a 57-year-old man without diabetes who developed sweating, agitation and confusion after taking one V8 tablet nightly for three nights. He had purchased V8 because he was unable to fill his usual sildenafil prescription for erectile dysfunction. He was taken to a hospital emergency department and was found to have a dangerously low blood sugar level. His doctor and the local poison center suspected sulfonylurea poisoning.

After the first case, an outbreak investigation was launched by the Virginia health officials. From August to November 2019, 16 additional cases of severe hypoglycemia were identified in men who had ingested V8 supplements and who had no history of using insulin or other medication used to control blood sugar. According to the patients, the V8 had been sold in clear jars without an ingredient list or warning label. Both glyburide and sildenafil were detected in the blood and urine of some of the patients.

Samples of V8 were obtained from the patients’ personal inventories and from several stores throughout Virginia and tested by a state public health laboratory. Testing demonstrated that all samples contained 55 to 156 milligrams (mg) of sildenafil per tablet — as much as three times the usual recommended prescription dose for erectile dysfunction — and that most samples contained 90 to 100 mg of glyburide — a potentially fatal dose that is about five to 10 times higher than the usual dose for treating diabetes.

You can best protect yourself by never using dietary supplements marketed for sexual enhancement. The average person is not able to distinguish those supplements that truly contain only natural ingredients from those tainted with active pharmaceutical ingredients. Moreover, there is no evidence that the former work, and the latter could kill you.