Dietary supplement found to contain unapproved Viagra-like drug

A dietary supplement marketed under the name STEAM is being recalled after it was found to contain a chemical similar to the drug found in the erectile dysfunction drug Viagra, the U.S. Food and Drug Administration (FDA) announced today.

The chemical, sulfoaildenafil, is an analog of sildenafil, the active ingredient in Viagra, the FDA said, making the product STEAM an unapproved drug.

The ingredient may interact with blood pressure drugs containing nitrates causing a dangerous drop in blood pressure, the FDA warned.

“Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product,” the FDA said.

STEAM is a product of Nutracostal Trading LLC, which is voluntarily recalling the product.

To learn more:

• Read the full text of the FDA’s press release announcing the recall, which includes the product number of the recalled supplement, is below or visit the FDA’s Website for additional materials.
• Read the National Library of Medicine’s MedlinePlus information pages on sildenafil and erectile dysfunction.

FDA Press Release:

Steam Dietary Supplement

Audience: Consumers, pharmacists

[Posted 07/29/2009] Nutracoastal Trading LLC and FDA notified healthcare professionals and consumers of a nationwide recall of the company’s dietary supplement product sold under the name Steam.

Lab analysis by FDA found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Steam an unapproved drug.

The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product was distributed in white plastic bottles to retail stores nationwide.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Tags: ED, erectile dysfunction, FDA, Nutracoastal Trading LLC, Product Recall, sildenafil, STEAM, Viagra

Category: Drugs & Medicines, Male Reproductive System, Men's Health, Product Recall, Sexual Health, Vitamins & Supplements