FDA Warns Sexual Enhancement Supplement Contains Unapproved Medication

FDA Warns Sexual Enhancement Supplement Contains Unapproved Medication
November 24, 2014

The U.S. Food and Drug Administration (FDA) is advising consumers against purchasing or using a dietary supplement marketed for sexual enhancement.

An FDA laboratory analysis confirmed that Black Storm contains sildenafil, which is the active ingredient in Viagra, a prescription drug used to treat erectile dysfunction.

Sildenafil is not approved for use the supplement, which is sold online and possibly in some retail stores.

This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program.

The FDA issued the notification to address a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being all natural. The FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.