FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan)
The FDA issued the following alert on 28 December 2007
Press release
Date: |
28 December
2007 |
Subject: |
FDA Warns Consumers Not to Use
Super Shangai, Strong Testis,
Shangai Ultra, Shangai Ultra X, Lady Shangai,
and Shangai Regular (also
known as Shangai Chaojimengnan)
|
Contact: |
Media
Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA |
The U.S. Food and Drug
Administration (FDA) is advising
consumers not to buy or use Super Shangai,
Strong Testis, Shangai Ultra, Shangai
Ultra X, Lady Shangai, and Shangai Regular,
also marketed as Shangai
Chaojimengnan, products.
These products, which
originate in China, are being
marketed for the treatment of erectile
dysfunction (ED) and for sexual
enhancement. Although labeled as dietary
supplements, these products do not
qualify as dietary supplements because they
contain undeclared active
ingredients of FDA-approved prescription
drugs for erectile dysfunction. The
products are thus drugs that are illegal
because they lack FDA approval.
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, they may seek out
products like these because they are
marketed as "all natural" or as not
containing the active ingredients in
approved, prescribed ED drugs. Additionally,
because the manufacturing source of
the active ingredients in these products is
unknown, consumers should be aware
that the safety, efficacy, and purity of
these ingredients can not be
validated.
"Products like
these put consumers at considerable risk
because they contain undeclared active
ingredients in FDA approved drugs that
require a prescription to obtain," said
Janet Woodcock, M.D., FDA's deputy
commissioner for scientific and medical
programs, chief medical officer, and
acting director of the Center for Drug
Evaluation and Research (CDER). "An
unsuspecting consumer with underlying medical
issues may buy and take these
products without knowing that they can cause
serious drug interactions."
FDA performed chemical
testing of the products that
revealed that Super Shangai, Strong Testis,
Shangai Ultra, Shangai Ultra X, and
Lady Shangai contain sildenafil, the active
ingredient in Viagra, an
FDA-approved drug for erectile dysfunction.
Shangai Regular, also marketed as
Shangai Chaojimengnan, contains an unapproved
substance with a structure similar
to sildenafil that may cause similar side
effects and drug interactions. Neither
sildenafil nor the analog of sildenafil is
listed as an ingredient on the label
of any of these products.
FDA advises consumers
who have used any of these products
to discontinue use and consult their health
care providers 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
FDA's MedWatch program at 800-FDA-1088 or
online at
www.fda.gov/medwatch/report.htm.
FDA recommends that consumers should talk to
their health care provider about
FDA-approved treatments for erectile
dysfunction. FDA may take further
regulatory actions to protect consumers from
these illegal products.
The products are
packaged and distributed by Shangai
Distributor, Inc. of Coamo, Puerto
Rico.
Click here to go to the FDA site
About The SafeMeds Alert System
The SafeMeds Alert System is a counterfeit alert
distribution service of the the Partnership
for Safe
Medicines--a group of
organizations and individuals that have policies,
procedures, or programs to protect consumers from
counterfeit or contraband medicines.