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FDA Warns Against Three “Sexual Enhancement” Supplements

FDA Warns Against Three “Sexual Enhancement” SupplementsThe manufacturer of a supplement called The Beast has issued a voluntary recall of the product after the U.S. Food and Drug Administration (FDA) discovered an erectile dysfunction (ED) drug among the ingredients.

The agency has advised consumers to stop using The Beast capsules and return them to the place of purchase.

The capsules are manufactured by Stiff Boy, LLC. and distributed online in the United States. They are touted to enhance sexual performance, but their safety and efficacy have not been proven by the FDA.

In laboratory tests, the FDA found that The Beast contains sildenafil, the active ingredient in Viagra, a drug commonly prescribed to men with erectile dysfunction (ED).

Sildenafil is classified as a phosphodiesterase type 5 (PDE 5) inhibitor and is available only by prescription.

While PDE 5 inhibitors are an effective ED treatment for many men, they are not safe for all patients. Men who take nitrates for conditions like diabetes, high blood pressure, high cholesterol, and heart disease should never take PDE 5 inhibitors because drug interactions can cause a dangerous drop in blood pressure.

As of now, no adverse events related to The Beast have been reported. The manufacturer has notified customers of the recall by email and is arranging for product returns. Customers may contact Stiff Boy, LLC by phone at (914) 281-4059 or email at info@youcanbeabeast.com with any questions.

Last month, the FDA advised consumers not to purchase or use two other “sexual enhancement” supplements for similar reasons:

  • Man Fuel Xtreme Edition was found to contain sildenafil and structurally similar compounds dithiodesmethyl carbodenafil and desmethyl carbodenafil.
  • Man Fuel Male Enhancement Shooter (Tropical Fruit Flavor) was found to contain tadalafil (the active ingredient in the ED drug Cialis, also a PDE5 inhibitor) and the structurally similar compound desmethyl carbodenafil.

Consumers who have had side effects from using any of these products should contact their healthcare provider. They may also make a report to the FDA’s MedWatch Adverse Reporting program.

Resources

Urology Place

“FDA Announces New Supplement Recall”

(June 6, 2019)

https://community.auanet.org/blogs/policy-brief/2019/06/05/fda-announces-new-supplement-recall

U.S. Food and Drug Administration (FDA)

“Public Notification: Man Fuel Male Enhancement Shooter (Tropical Fruit Flavor) contains hidden drug ingredients”

(May 22, 2019)

https://www.fda.gov/drugs/medication-health-fraud/public-notification-man-fuel-male-enhancement-shooter-tropical-fruit-flavor-contains-hidden-drug

“Public Notification: Man Fuel Xtreme Edition contains hidden drug ingredients”

(May 22, 2019)

https://www.fda.gov/drugs/medication-health-fraud/public-notification-man-fuel-xtreme-edition-contains-hidden-drug-ingredients

“STIFF BOY LLC. Issues Voluntary Nationwide Recall of THE BEAST Capsules Due to Presence of Undeclared Sildenafil”

(June 3, 2019)

 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stiff-boy-llc-issues-voluntary-nationwide-recall-beast-capsules-due-presence-undeclared-sildenafil