Dangerous Ingredient Found in Sex Enhancement Supplements

The FDA today published several public notifications advising consumers to avoid a number of supplemental products marketed for sexual enhancement that were found to contain a potentially dangerous, undeclared ingredient.

These warnings follow an FDA laboratory analysis which concluded that the OTC supplements contained sildenafil, the active ingredient of Pfizer’s erectile function drug, Viagra.

The FDA expressed particular concern that these products might be used by men taking nitrates for diabetes, high blood pressure, high cholesterol, or heart disease. Sildenafil can potentially interact with nitrates, leading to unsafe and even deadly drops in blood pressure.

As of March 3, 2015, the OTC products found to contain sildenafil include:

• Vigra
• Plant Vigra
• Sex Men
• Super Hard
• Hard Wang
• Santi Scalper
• Vigour 300
• FX3000
• MME Maxman

In a recently published analysis of OTC sexual enhancement products, Anyssa Garza, PharmD, explained that manufacturers often market these products using misleading, unverifiable, or untrue claims. Because these products are easily accessible, Dr. Garza wrote, pharmacists should remain informed about their effects so that they may better educate patients.

Both Dr. Garza and the FDA itself noted that the agency cannot examine or verify the claims of all supplemental products and recommended that consumers exercise caution before purchasing or using any such product.

In addition to contacting their health care professionals, patients who have experienced adverse reactions after using these products should report them to the FDA’s MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.