Ultra Health Laboratories, Inc. and Bionate International, Inc. warned consumers not to purchase or consume a product known as Vinarol tablets, promoted for increasing desire, confidence and sexual performance. This product, marketed as a dietary supplement and sold over the counter as well as via the Internet, contains the unlabeled prescription drug ingredient, sildenafil, which may pose possible serious health risks to some users.

The interaction between nitrates and sildenafil can result in profound and life-threatening lowering of blood pressure. The use of nitrates in any form 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.

Read the 2003 MedWatch safety alert, including a link to the company press release, at:

http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#vinaro