FDA Warning - FYI
Something new is advertised or appears on the shelves, and if
you are like me, you are curious. Will it do what it claims?
Is it safe, or does it have any negative properties? What's in
it? And so on.
Here is one that you need to keep your eye out for, and
definitely avoid.
Annette
http://www.medscape.com/viewarticle/518620 FDA Warns Against
Use of Miracle II Neutralizer Products Yael Waknine Medscape
2005. © 2005 WebMD Inc.
Dec. 7, 2005 - The US Food and Drug Administration (FDA) has
advised consumers against the use of Miracle II Neutralizer
and Neutralizer Gel products manufactured by Tedco, Inc, due
to safety and efficacy concerns, according to an alert sent
yesterday from MedWatch, the FDA's safety information and
adverse event reporting program.
The FDA warned that the company's promotional health claims
for the products were deceptive and untruthful, and their use
may lead to serious adverse events such as infections.
Susceptible populations such as children, the elderly, and
individuals with weakened immune systems may be at increased
risk for these events.
Although Miracle II Neutralizer has been promoted by the
manufacturer for the treatment of cataracts and pink eye, and
for use as an eyewash, it does not meet FDA sterility
requirements for ophthalmic products. Because of the
substantial risk for bacterial infection, the solution should
never be applied to the eyes.
Other unapproved indications promoted by the company have
included treatment of AIDS, cancer, Crohn's disease,
dermatitis, diaper rash, diabetes, earache, hemorrhoids,
hives, gout, herpes, mouth ulcers, psoriasis, skin cancer, and
yeast infection. Miracle II Neutralizer Gel has also been
marketed for many of these indications, including diaper rash,
diabetes, gout, psoriasis, and skin cancer.
Moreover, the company's promotional material claims that
superior technology renders the product useful as a cleaner,
deodorizer, natural insecticide, and antibacterial agent.
In contrast, FDA investigations have revealed bacterial
contamination and poor manufacturing conditions. The company
has declined to voluntarily remove the products from the
market despite notification of these findings.
Miracle II Neutralizer and Miracle II Neutralizer Gel are sold
in 8-oz, 22-oz, and one-gallon containers. They are marketed
by a number of stores and achieve worldwide distribution via
Internet sales.
Consumers, healthcare providers, and caregivers are advised to
cease using and dispose of these products.
Adverse events related to the use of Miracle II products
should be reported to the FDA's MedWatch program by phone at
1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
http://www.fda.gov/medwatch/report.htm, or by mail to 5600
Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Gary D. Vogin, MD
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