Fat Burning Diet Supplement Suspected in Liver Damage and Death
Last weekend the FDA announced that USPlabs of Dallas is recalling its OxyElite Pro products because of concerns of reports that as many as 56 reported cases of liver illness - including one death - may be attributed this popular fat burning diet supplement.
The link between taking OxyElite Pro products and liver disease came to light after the Centers for Disease Control and Prevention noted an outbreak of liver disease in patients who were admitted to Hawaii’s only liver transplant center. Health authorities became suspicious after noticing an unusual pattern of severe hepatitis among patients who were otherwise healthy.
An FDA review of medical records provided by the Hawaii Department of Health indicated that of the affected patients, 58% had taken an OxyElite Pro product before becoming ill of which 63% reported that it was their sole supplement.
In a letter of warning to USPlabs the FDA stated that their OxyElite Pro line of supplements had been linked to liver illnesses and that there is a reasonable suspicion that their products are adulterated. USPlabs then issued a voluntary recall and is investigating the matter.
USPlabs recently also had difficulties with questions about the safety of another fat burning supplement called “VERSA-1” that the FDA determined was adulterated with an ingredient called “Aegeline.”
Aegeline is a relatively new ingredient that is being added to dietary supplements for weight loss and muscle building. It is extracted from the leaves of the Bael tree (Aegle marmelos)—a plant that has been used for centuries in Ayurvedic medicine for weight loss.
Only a scant amount of recent scientific research has been done on Aegeline with reports that in some animal studies it appears to have not only anti-obesity properties but that it also can help lower elevated blood sugar levels. However, its safety in humans is not known and thereby the public is advised to avoid supplements that contain Aegeline such as VERSA-1. Consumers are told that Aegeline may also be listed on a product label of other supplements as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide.
A listing of USPlabs recalled supplements that consumers should discontinue buying and using is as follows:
OxyElite Pro Super Thermo capsules
• Two count capsules UPC #094922417275
• 10 count capsules UPC #094922417251
• 10 count capsules UPC #094922417268
• 21 count capsules UPC #094922426604
• 90 count capsules UPC #094922395573
• 90 count capsules “Pink label” UPC #094922447906
• 180 count capsules UPC #094922447852
OxyElite Pro Ultra-Intense Thermo capsules
• Three count capsules UPC #094922447883
• Three count capsules UPC #094922447876
• 90 count capsules UPC #094922395627
• 180 count capsules UPC #094922447869
OxyElite Pro Super Thermo Powder
• Fruit Punch 0.15 oz. UPC #094922417237
• Fruit Punch 0.15 oz. UPC #094922447517
• Fruit Punch 4.6 oz. UPC #094922426369
• Fruit Punch 5 oz. UPC #094922447487
• Blue Raspberry 4.6 oz. UPC #094922426376
• Grape Bubblegum 4.6 oz. UPC #094922447500
• Green Apple 4.6 oz. UPC #094922426499
The FDA tells consumers that if they suspect that they have suffered a serious harmful effect or illness from a dietary supplement, they should contact their health care provider who can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088. Furthermore, other supplements containing Ayurvedic ingredients should also be investigated thoroughly by consumers before buying as some have been found to be contaminated with heavy metals.
For an informative article about other fat burning supplement warnings, click-on the following titled link, “Side Effect Belly Fat Supplement Warning for 7-Keto, Forskolin, Relora & Caraway.”
“Anti adipogenic activity of Aegle marmelos Correa” Phytomedicine (2013) Nov 15; 20(14):1267-71; Karmase A. et al.
"Antihyperglycemic and antidyslipidemic agent from Aegle marmelos" Bioorganic & Medicinal Chemistry Letters (2007) Mar 15; 17(6):1808-11; Narender T. et al.