Vinarol and Viga Tablets Contaminated with Sildenafil (Viagra)
June 6, 2003
The manufacturers of Vinarol and Viga tablets, promoted for increasing desire, confidence and sexual performance, recently issued recalls and warned consumers not to purchase or consume the products. Vinarol and Viga are marketed as dietary supplements and sold over the counter and on the Internet. Vinarol is distributed by Ultra Health Laboratories, Inc. and/or Bionate International, Inc.; Viga is distributed by Best Life International.
U.S. Food and Drug Administration (FDA) investigators found that the tablets contained the unlabeled prescription drug ingredient, sildenafil (the prescription ingredient found in Viagra), which may pose possible serious health risks to some users.
Sildenafil can interact with prescription nitrates that are used to treat chest pain and can cause a life-threatening drop in blood pressure. The use of nitrates is an absolute contraindication for sildenafil users. The potential for this product to be taken by unknowing nitrate users is real, since erectile dysfunction is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia, smokers, and patients with ischemic heart disease.
Advice to Consumers
Safety is a concern to users of these products. Consumers who have purchased Vinarol or Viga should immediately discontinue use and return the tablets to the place of purchase for a refund. Use of these tablets with sildenafil could cause life-threatening problems for certain patients, especially those who are taking any form of nitrates.
Consumers who have used these products and have medical concerns should contact their health care provider.
For More Information
View the FDA Safety Alerts and the manufacturers' press releases on the FDA Web site at www.fda.gov/medwatch/SAFETY/2003/safety03.htm.
