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FDA: Chelation not proven safe or effective in treating autism

Posted Oct 14 2010 1:29pm

Chelation is a process whereby metals are removed from the body using a drug, a chemical which binds to the metals and allows them to be excreted. Because of the incorrect notion that autism is caused by mercury or is a “novel” form of mercury poisoning, chelation is one of the more common alternative medical therapies applied to autistics.

The FDA has recently issued a warning to many of those who market unapproved chelators. Two articles appear on the FDA website today:

FDA Tightens Reins on Unapproved ‘Chelation’ Drugs

and a press release

FDA issues warnings to marketers of unapproved ‘chelation’ products .

They have also issued a printer-friendly pdf: FDA chelation warning pdf

From that pdf:

Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease by removing toxic metals from the body.

The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

The groups that have been warned are:


• World Health Products, LLC: Detoxamin
Oral, Detoxamin Suppositories, and the
Metal Detector test kit
• Hormonal Health, LLC and World Health
Products, LLC: Kelatox Suppositories,
and the METALDETECTOR Instant Toxic
Metals Test
• Evenbetternow, LLC: Kids Chelat Heavy
Metal Chelator, Bio-Chelat Heavy Metal
Chelator, Behavior Balance DMG Liquid,
AlkaLife Alkaline Drops, NutriBiotic
Grapefruit Seed Extract, Natur-Leaf,
Kids Clear Detoxifying Clay Baths, EBN
Detoxifying Bentonite Clay, and the
Heavy Metal Screen Test
• Maxam Nutraceutics/Maxam Laboratories PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx,
Anavone, AV-Rx, BioGuard, BSAID, CF-Rx,
CreOcell, Dermatotropin, Endotropin,
GTF-Rx, IM-Rx, Keto-Plex, Natural Passion,
NG-Rx, NX-Rx, OR-Rx, Oxy-Charge,
PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and
the Heavy Metal Screening Test
• Cardio Renew, Inc: CardioRenew and
CardioRestore
• Artery Health Institute, LLC: Advanced
Formula EDTA Oral Chelation
• Longevity Plus: Beyond Chelation
Improved, EndoKinase, Viral Defense,
Wobenzym-N
• Dr. Rhonda Henry: Cardio

I wonder how the FDA chose these groups for the first round of warnings. I also wonder if/when there will be more warning letters.

Also from the FDA pdf:

FDA says consumers should avoid nonprescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.

I don’t know why the FDA has taken so long to step in and take action. Chelation has been going on for years, and has never had a sound basis in science or even a good rationalization for the treatment of autism.

Trine Tsuderous has an article on the Los Angeles Times website, FDA warns about treatments for autism, heart disease .

  1. Tweets that mention Autism Blog - FDA: Chelation not proven safe or effective in treating autism « Left Brain/Right Brain -- Topsy.com:
    [...] This post was mentioned on Twitter by Kev, Alltop Autism and Tammy, Tammy. Tammy said: RT @kevleitch FDA: Chelation not proven safe or effective in treating autism: ... http://bit.ly/dCeGRG #autism#chelation#biomedical [...]
  2. David N. Brown:
    Now will Doctor's Data, Inc sue the FDA?
  3. Dawn:
    @DNB: that made me LOL. Thanks!
  4. Sullivan:
    Age of Autism (probably Kim Stagliano) used twitter to claim: http://twitter.com/AgeofAutism/status/27487064413
    Chelation is for the heavy metal poisoning that causes the neurological damage that RESULTS in behaviors called autism. Not autism itself.
    I am not surprised that they are worried about this action. I am also not surprised that they stick to the failed story about mercury poisoning being related to mercury. It's time to catch up to the present, a time when the mercury hypothesis is dead.
  5. Fred Winters:
    Do we have health freedom in America? I guess not...the FDA is here to protect us, oh I'm so glad! Not! The FDA is at it again, removing competition for mainstream drug and western medicine surgery procedures. If I want to try chelation for something, then that is my right and freedom. I don't need a fraudulent, corporate controlled FDA to tell me what is safe or not. Look it up people, prescription drug overdoses and hospital mistakes is the 3rd leading cause of death in America. When will we wake up and stop letting the FDA remove our health freedoms? When?

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