Older Men Should Not Use Blue Steel or
Hero for Erectile Dysfunction
FDA says products are illegal drugs and pose serious
health risks
March 27, 2008 Older men, the Americans most
likely to be interested in products marketed for the treatment of
erectile dysfunction (ED) and sexual enhancement, are being warned by
the Food and Drug Administration not to purchase or use "Blue Steel" or
"Hero" products marketed as dietary supplements. The FDA says they are
considered unapproved drugs and have not been proven to be safe or
effective.
These products, sold over the Internet, contain
undeclared ingredients, which may dangerously affect a persons blood
pressure level.
Theyre touted as all natural and labeled as
dietary supplements, according to the FDA warning yesterday.
However, Blue Steel and Hero products do not
qualify as dietary supplements because they contain undeclared and
unapproved substances that are similar in chemical structure to
sildenafil, the active ingredient in Viagra, an FDA-approved
prescription drug for ED, the agency says in the warning.
"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 FDAs
Center for Drug Evaluation and Research.
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Dangerous
Products Increasing Online
"The number of these problematic products
available on the Internet appears to be increasing," says Linda
Silvers, leader of FDA's Internet and Health Fraud Team, part of
the Office of Compliance (OOC) in the Center for Drug Evaluation
and Research (CDER).
"Many consumers perceive these products
as completely safe because they are often sold with labeling,
suggesting that they are all-natural alternatives to
prescription drug products that have been approved by FDA for
treating ED," she says.
"But these products may be laced with
potentially hazardous ingredients that aren't noted on the
label."
Since 2004, FDA has become aware of
several such "dietary supplements."
Click here to complete list (pdf). |
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.
FDA chemical analysis revealed that both Hero and
Blue Steel contain substances that are similar in chemical structure to
sildenafil; however, they are not components of an FDA approved drug.
Additionally, the products label do not list any of these substances.
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.
For more information, visit:
http://www.fda.gov/consumer/updates/erectiledysfunction010408.html
