Re: FDA Warning - FYI

I'd think carefully about *anything* that has "miracle" in its name.
:-)
I'd also be extremely careful about anything I used in my eyes -- check with
ophthalmologist first, at least.
bj

"Annette" <acianthus@xxxxxxxxxxx> wrote in message
news:8BVmf.17495$ea6.5713@xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
> 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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