Image for FDA: Sexual Enhancement Product Contains Undeclared Ingredient
News
Copyright 2013 Natural Standard (www.naturalstandard.com)
June 2013

FDA: Sexual Enhancement Product Contains Undeclared Ingredient

The U.S. Food and Drug Administration (FDA) recently issued a warning regarding the sexual enhancement product Royal Dragon Herbal Tonic Balls.

An FDA laboratory analysis revealed that Royal Dragon Herbal Tonic Balls contains the hidden ingredient vardenafil. This substance is the active ingredient in the FDA-approved prescription drug Levitra, which is marketed for erectile dysfunction (ED).

The FDA warns that vardenafil may interact with nitrates found in some prescription drugs, such as nitroglycerin. This hidden ingredient may significantly lower blood pressure to dangerous levels. Nitrates are commonly taken by men who have diabetes, heart disease, high blood pressure, or high cholesterol.

The FDA advises consumers in possession of Royal Dragon Herbal Tonic Balls to discard this product immediately and to report any side effects to a healthcare provider. Side effects associated with this product should also be reported to the FDA's Medwatch Safety Information and Adverse Event Reporting Program.

For more information about erectile dysfunction, please visit Natural Standard's Medical Conditions Database.

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.