Image for FDA: OxyElite Pro and VERSA-1 Dietary Supplements Linked To Liver Illness
News
Copyright 2013 Natural Standard (www.naturalstandard.com)
November 2013

FDA: OxyElite Pro and VERSA-1 Dietary Supplements Linked To Liver Illness

The U.S. Food and Drug Administration (FDA) has announced that USPLabs LLC is recalling certain of its OxyElite Pro dietary supplements after reports linking the products to liver illnesses.

The Hawaii Department of Health submitted 46 medical records to the FDA for review. These records indicated that 27 people had become ill after taking a product labeled as OxyElite Pro. Of these individuals, 17 reported that they were taking no other supplements in addition to OxyElite Pro. One death has been reported among these individuals, one person has needed a liver transplant, and others are awaiting liver transplants.

On November 6, 2013, the FDA notified USPLabs regarding the association between OxyElite dietary supplements and the development of liver illnesses in Hawaii. The FDA reported that cases of liver damage have also been found in other states.

In the warning letter, the FDA informed USPLabs that OxyElite Pro and another product called VERSA-1 were found to contain a substance known as aegeline. This ingredient lacks a history of use as well as other safety evidence. The FDA stated in its letter that failure to stop product distribution of aegeline-containing supplements might result in enforcement action.

The FDA has warned consumers to avoid using any dietary supplements that are labeled as OxyElite Pro or VERSA-1.

Consumers who believe that they may be experiencing negative side effects associated with these products should contact a medical professional. Healthcare providers and consumers are advised to report side effects related to the use of these supplements to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. US Food and Drug Administration. www.fda.gov
The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited. Natural Standard is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.