Erectile Dysfunction Products Blue Steel and Hero May Pose Health Risks, FDA Warns
March 26th, 2008 amy
Per an FDA press release March 25, consumers are being advised against using “Blue Steel” or “Hero” marketed as all natural dietary supplement products to treat erectile dysfunction and cause sexual enhancement, because these products contain an undeclared ingredient which may dangerously affect a person’s blood pressure level. These products contain a substance similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED. But the FDA says these “Blue Steel” or “Hero” products are considered unapproved drugs and have not been proven to be safe or effective.
“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.”
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, these men may seek products like Blue Steel and Hero because the products are marketed as “all natural” or as not containing the active ingredients in approved ED drugs.
The FDA advises consumers who have used either of these products to discontinue use and consult their health care professional if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. The FDA recommends that consumers should talk to their health care professional about FDA‑approved treatments for erectile dysfunction. The FDA may take further regulatory actions to protect consumers from these illegal products.
Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules. Both products distributed by Active Nutraceuticals or the Marion Group, Carrollton, Ga.
