WebMD Health News
Louise Chang, MD
March 26, 2008 -- The FDA is warning consumers not to buy or use "Blue
Steel" or "Hero" dietary supplements promoted and sold online for erectile dysfunction (ED) treatment.
Those products are unapproved drugs that haven't proven their safety or
effectiveness, and they contain unapproved chemicals similar to sildenafil,
Viagra's active ingredient, according to the FDA.
Those chemicals, which aren't noted on the Blue Steel and Hero product
labels, "may dangerously affect a person's blood pressure level," an
FDA news release states.
"Because these products are labeled as 'all-natural dietary
supplements,' consumers may assume that they are harmless and pose no health
risk," says Janet Woodcock, MD, director of the 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 could interact with nitrates
found in some prescription drugs (such as
nitroglycerin) and can lower blood pressure to dangerous levels.
People 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
The FDA advises people 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 or health care professionals can report adverse events to the
FDA's MedWatch program by phone at 800-FDA-1088 or on the FDA's web site.
The FDA recommends that consumers talk to their health care professional
about FDA-approved treatments for erectile dysfunction. The FDA also says it
may take further regulatory actions to protect consumers from these illegal
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.
SOURCE:News release, FDA.
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