FDA Issues Alert on Risks with Supplements Marketed for Erectile Dysfunction

By Peggy Peck
ROCKVILLE, Md., March 26 -- Two dietary supplements marketed over the Internet as purported erectile dysfunction treatments may contain ingredients that can cause dangerous hypotension, the FDA has warned.
The two products, Blue Steel and Hero, are "considered unapproved drugs and have not been proven to be safe or effective," the FDA said.
The products may contain ingredients that could interact with nitroglycerin and other nitrate products to "lower blood pressure to dangerous levels," the FDA said.
The FDA said men who have used either product should halt their use and should consult a physician if they have had any unanticipated or suspicious adverse events.
Erectile dysfunction, the FDA noted, is a common side effect of conditions for which nitrate compounds may be prescribed, such as diabetes, hyperlipidemia, hypertension, and heart disease.
The FDA said men with those conditions are often warned not to take prescription erectile dysfunction drugs such as sildenafil (Viagra) and tadalafil (Cialis), which might make them opt for dietary supplements and other so-called natural remedies.
But the FDA said that Blue Steel and Hero "do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil."
Moreover, the products' labels don't include a detailed list of ingredients.
"Because these products are labeled as 'all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."
Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two capsules per pack. Hero is sold in two-capsule blister packets. Both products are distributed by Active Nutraceuticals or the Marion Group of Carrollton, Ga.