October 2015

According to the U.S. Food and Drug Administration (FDA), nearly 300 products labeled as "dietary supplements" or "foods" marketed to improve sexual performance or increase sexual stimulation in men may contain hidden drugs or other undisclosed ingredients that can be dangerous. Some of these products were found to contain the same active ingredients in prescription medications approved to treat erectile dysfunction (e.g., Viagra, Cialis, Levitra).

Manufacturers of many of these products fail to list potentially dangerous ingredients, combinations of ingredients ("drug cocktails"), and/or excessively high doses on the product labels, the FDA reports. In addition, the products may be labeled as "all natural" or "herbal"—further misleading consumers into thinking they are safe alternatives to approved ED medications.

Products that may contain hidden drugs or other undisclosed ingredients include pills, dissolvable oral strips, chewing gum, and even coffees. They are often sold in single-serving sizes and can be purchased online and in stores, vending machines, travel stops, and gas stations.

According to the FDA, some products tested contained several times the approved dose of ED medication and some contained drugs that are not approved by the Administration. These drugs can be especially dangerous for men who take other prescription or over-the-counter (OTC) medications, those with certain medical conditions (e.g., heart disease, high blood pressure, diabetes), those who drink alcohol or use illegal drugs, and others.

One potentially serious adverse reaction can occur when products containing the active ingredient in Viagra (sildenafil) is combined with medications containing nitrates (e.g., heart medications). This combination can cause a dangerous drop in blood pressure.

Dietary supplements may be legally marketed without prior evaluation by the FDA for safety and effectiveness. The Food and Drug Administration inspects such products after marketing or when investigating adverse effects. Manufacturers are required by law to make sure dietary supplements are safe and that all claims about the product are true.

The FDA warns that men should avoid products that:

  • Promise to improve sexual performance quickly (e.g., within 30 minutes)
  • Are advertised as alternatives to approved prescription ED drugs
  • Are sold in single use sized
  • Are sold in the United States, but have labels written primarily in a foreign language
  • Are labeled with directions and warnings that mimic labels on FDA-approved products

Although the FDA has taken steps to warn consumers and health care providers and stop the sale of these illegal products, some of them remain available. Talk to your doctor before taking any new supplement.

Source: U.S. Food and Drug Administration (FDA)

Publication Review By: the Editorial Staff at Healthcommunities.com

Published: 19 Oct 2015

Last Modified: 20 Oct 2015