FROM THE BENCH
Virginia Responds to Severe Hypoglycemic Reactions Induced by Ingestion of Herbal Supplements
By Shane Wyatt , lead scientist , Division of Consolidated Laboratory Services , Department of General Services , Commonwealth of Virginia
The
Division of Consolidated Laboratory Services ( DCLS ), under the Department of General Services , is the public health laboratory for the Commonwealth of Virginia . DCLS provides analytical testing services to other state agencies in suspected poisoning cases . In August 2019 , several individuals were admitted to emergency rooms in Richmond and Lynchburg , VA , for severe hypoglycemia . In total , 17 patients were hospitalized for recurring episodes of extremely low blood sugar ( Figure 1 ).
All individuals were male and selfreported use of an herbal supplement as an aid to sexual performance . The products were marketed under the name “ V8 ” and sold three at a time in clear plastic bottles . The cases were first reported out by
Virginia Poison Control to local health departments in affected areas . The
Virginia Department of Agriculture and Consumer Services was enlisted as the regulatory agency with oversight of the sales of the supplement and to assist in removing stock from shelves . A task force of the involved agencies was created to investigate the cases and determine the cause of the severe hypoglycemia .
# Patients Age Range
Laboratory Response
Blood Glucose Range
DCLS received several supplements from the affected individuals , as well as pills that were pulled from retail stores as part of the confiscation , for analysis . DCLS is a Laboratory Response Network Level 1 Chemical Emergency Response Laboratory ( LRN-C ), as well as a
Food Emergency Response Network Cooperative Agreement ( cFERN ) laboratory . As part of these programs , DCLS has trained staff that respond to suspected chemical exposures by analyzing clinical , food and environmental samples for unknown chemical compounds and have responded in this capacity for 20 years . For this investigation , a literature search found similar cases reported in
2009 with severe hypoglycemia after ingestion of a supplement contaminated with a sulfonylurea drug .
# Days Hospitalized
Figure 1 : Summary of demographic and clinical data of individuals suffering from extreme hypoglycemia
# Days of Supplement Use Prior to Episode
17 33 - 73 11 - 66 1 - 6 1 - > 1 month
DCLS screened the supplements using high-resolution liquid chromatography mass spectrometry ( HRLC-MS ) for sulfonylurea drugs , or other active pharmaceutical ingredients . HRLC-MS is a very useful technique since it provides the exact molecular mass of the analytes detected , making identification of unknown compounds simpler . Analysis of the supplements found that all of the pills contained the active ingredient sildenafil and several of the supplements contained the sulfonylurea drug glyburide . All of the supplements collected from individuals suffering from severe hypoglycemia had glyburide ( Figure 2 ). It should be noted that the concentration range of sildenafil in the suspected tablets was the same as the recommended low and high dosage in commercial products . The concentration range of glyburide , however , was 5-10 times higher than the therapeutic dose for the treatment of diabetes . Glyburide was only found in pills that had the low concentration of 55 mg / pill of sildenafil .
Active Ingredient Sildenafil Glyburide
Concentration Range Detected
55 – 156 mg / pill 90 – 100 mg / pill
Figure 2 : Concentration ranges of active ingredients found in V8 herbal supplements
Left : Back of herbal supplements suspected to contain sulfonylurea drugs . DCLS received samples in the original packaging , similar in shape and color to commercial erectile dysfunction medications . Photo : DCLS
Right : Front of herbal supplements suspected to contain sulfonylurea drugs . DCLS received samples in the original packaging , similar in shape and color to commercial erectile dysfunction medications . Photo : DCLS
Glyburide is an oral diabetes medicine that helps control blood sugar levels . Glyburide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus . Maximum recommended dose : 20 mg / day .
14 LAB MATTERS Winter 2021