I am sorry this has been so confusing. We can only tell you the risks that
have been associated with chelation therapy in the products that have been
studied and approved. Chelation therapy is not approved for mercury
poisoning. The adverse effects that have occurred in children while
treating lead poisoning can be found in the package insert. The drug
labeling, or package insert, that accompanies drug products, is the most
complete single source of information on the drug. They are available from
your local pharmacist and also reprinted in the Physician's Desk Reference
(PDR), which can be found in many libraries.
You may also obtain copies of adverse event reports submitted to FDA from
industry, health care providers, and consumers through Freedom of
Information:
http://www.fda.gov/opacom/backgrounders/foiahand.html
Chemet is an orphan drug that may be used for treatment of mercury
intoxication via chelation. Orphan drugs may be approved or may still be
experimental. A drug becomes an "orphan" when it receives orphan designation
from the Office of Orphan Products Development at the FDA. Orphan
designation qualifies the sponsor to receive certain benefits from the
Government in exchange for developing the drug. The drug must then go
through the new drug approval process like any other drug. To date over 1000
orphan products have been designated and over 200 have been approved for
marketing.
http://www.fda.gov/orphan/
Please also be aware that the FDA is empowered by law to review drug
products for safety and effectiveness. Once approved, a drug product may be
prescribed by a licensed physician for any use that, based on the
physician's professional opinion, is deemed to be appropriate. This action
is considered to be part of the practice of medicine. FDA does not regulate
the practice of medicine and cannot comment on, or recommend, a course of
treatment for any individual. The best protection as a consumer/patient is
to educate yourself about any drug that your doctor prescribes.
In addition, you may read about mercury poisoning by using the search engine
at the following site:
http://www.nlm.nih.gov/medlineplus/
I hope this information is helpful.
Sincerely,
CDER/DrugInfo - RC
-----Original Message-----
From: HCN [mailto:HCN@nospam.com]
Sent: Friday, January 16, 2004 2:31 PM
To: CDER DRUGINFO
Subject: Re: Chelation Therapy for Children with Developmental Concerns
And yet this still does NOT answer the original question:
>
http://www.fda.gov/cber/vaccine/thimfaq.htm#q23
>
> Would it be possible that this paragraph be expanded upon?:
Which has absolutely NOTHING to do with lead.
There are folks going about pumping their kids with DMSA (and sometimes
DMSO, because it sounds similar) using dubious results from dubious hair
analysis. These folks are getting this dubious advice from this dubious
group:
http://health.groups.yahoo.com/group/Autism-Mercury/
Thank you again for the effort,
HCN
----- Original Message -----
From: "CDER DRUGINFO" <DRUGINFO@cder.fda.gov>
To: "'HCN'" <HCN@nospam.com>
Sent: Friday, January 16, 2004 10:56 AM
Subject: RE: Chelation Therapy for Children with Developmental Concerns
>
> There are various derivatives of EDTA which are FDA approved in the
> pediatric population for treating lead poisoning by means of chelation.
FDA
> has approved these products on the basis of studies which showed evidence
of
> safety and effectiveness. As with any drug product, these products all
have
> associated risks, and should only be used when benefit outweighs risk.
>
> If you would like a copy of the product labeling for these products, which
> includes adverse event information, please respond to this email with your
> mailing address.
>
> Sincerely,
> CDER/DrugInfo - RC
>
> -----Original Message-----
> From: HCN [mailto:HCN@nospam.com]
> Sent: Tuesday, January 13, 2004 7:38 PM
> To: CDER DRUGINFO
> Subject: Re: Chelation Therapy for Children with Developmental Concerns
>
>
> Unfortunately, the answer did not address the question. I can assume that
> giving kids EDTA and DMSO is so new that it has not hit the FDA radar
> screen.
>
> Thanks for the effort, I just hope that no kids get injured with this
stuff.
> I shall try my best to steer parents away from putting odd chemicals into
> their kids... but I hope that someone will monitor the Autism-Mercury
Yahoo
> Group (which is where I have been told this practice is preached) and
sends
> out some warnings.
>
> Thanks,
>
> HCN
>
> ----- Original Message -----
> From: "CDER DRUGINFO" <DRUGINFO@cder.fda.gov>
> To: <HCN@nospam.com>
> Sent: Tuesday, January 13, 2004 9:29 AM
> Subject: RE: Chelation Therapy for Children with Developmental Concerns
>
>
> >
> > Thank you for contacting the Division of Drug Information at the FDA.
> >
> > Chelation agents are approved for treating poisonings with heavy metals.
> > There is no scientific or medical evidence known to FDA that chelation
> > therapy can have any preventative or protective benefits against the
> future
> > development of arteriosclerosis or any other indication. No evidence
has
> > ever been submitted to the FDA demonstrating that Chelation therapy is
> safe
> > and effective for the treatment of arteriosclerosis. Although chelating
> > agents are useful in treating acute lead poisoning, their chronic use,
to
> > combat continued exposure to lead, has not been shown to be effective
and
> > may cause harm.
> >
> > We hope that you find the following links helpful:
> >
> >
http://www.nccam.nih.gov/news/2002/chelation/q-and-a.htm#3
> >
> >
>
http://search.nlm.nih.gov/medlineplus/query?DISAMBIGUATION=true&FUNCTION=sea
> > rch&SERVER2=server2&SERVER1=server1&PARAMETER=chelation
> >
> >
> > Sincerely,
> > CDER/DrugInfo - RC
> >
> > -----Original Message-----
> > From: HCN [mailto:HCN@nospam.com]
> > Sent: Friday, January 09, 2004 2:34 PM
> > To:
octma@cber.fda.gov
> > Subject: Chelation Therapy for Children with Developmental Concerns
> >
> >
> > Dear All,
> >
> > I am a participant of a listserv run by ???? . There
have
> > recently been several messages touting the "benefits" of chelation for
> these
> > kids. I find this quite worrysome, but when I raise an alarm I find
only
> > scant data to support my opinion that it is a dangerous and not very
> useful
> > thing to do to kids. Like this:
> >
> >
http://www.fda.gov/cber/vaccine/thimfaq.htm#q23
> >
> > Would it be possible that this paragraph be expanded upon?:
> >
> > "It is also important to point out that the use of chelation therapy for
> > organic mercury poisoning is controversial, with some experts
questioning
> > its benefit. In addition, there are risks associated with chelation
> > therapy."
> >
> > I would like to find out WHAT risks... where, how... etc. If I had
tried
> > oral chelation for my son who has just been diagnosed with hypertrophic
> > cardiomyopathy with obstruction, would I have caused him harm? (actually
> I'm
> > just thankful we found out about it and he is on Antenolol before the
most
> > common way it is diagnosed: sudden cardiac death). I do find
information
> > on
www.quackwatch.org --- but the most ardent advocates of chelation
feel
> > that Dr. Barrett is unreliable... though I am baffled by parents who
decry
> > "toxins" in vaccines, yet pump EDTA or whatever into their kids.
> >
> > I also find it disturbing that if I put into
www.google.com the search
> words
> > "chelation child" I get all sorts of sites promoting oral chelation for
> > kids!
> >
>
http://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=chelation+child&btnG=
> > Google+Search
> >
> > Am I being more alarmed than necessary? Regardless of the physical
danger
> > to kids... I also find it scummy that folks are charging parents of
> disabled
> > kids lots of money for this kind of "treatment".
> >
> > Thank you,
> > HCN
> >
> >
>
>r