Chelation is Not Approved Therapy for Autism, warns FDA
Families of patients with difficult conditions understandably search for alternative treatments, in hopes of curing their loved ones, especially when there are few mainstream treatment options available. But some so-called “natural” therapies may be dangerous, as in the case of chelation – a legitimate medical therapy for heavy metal poisoning, but not approved for the treatment of other diseases such as autism, Parkinson’s disease, Alzheimer’s and heart disease. The FDA has recently sent warning letters to 8 practitioners to keep them from marketing over-the-counter chelation as a “cure”, particularly when it comes to autistic children.
Chelation Not an Approved Treatment for Neurological or Cardiovascular Diseases
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance with the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”
Chelation chemicals work by binding to metals in the body which are then excreted in the urine. It is used for treating metal poisoning, such as lead, mercury, iron, and arsenic. Proponents of its use in conditions such as autism claim that the condition is caused by heavy-metal poisoning (particularly mercury), and therefore chelation would help remove the compounds, curing the autism. Studies have failed to provide evidence to support this claim.
The chemicals used in chelation can cause serious harm when not used properly, including dehydration, kidney failure and death. In fact, the FDA reports a case of a 5-year-old autistic boy who was receiving chelation for autism who died of a heart attack in 2005. The physician treating the boy had his medical license suspended for three years and was sued by the child’s parents. A two-year-old girl from Texas also died after being treated with chelation.
The National Institutes of Health has no plans to study chelation in autistic children at this time, as risks outweigh the potential benefits. Animal studies have shown that rats with lead poisoning significantly improved in learning and behavior after chelation, but those without heavy-metal poisoning showed signs of cognitive damage after being treated.
However, the agency is conducting a chelation trial for coronary artery disease in adults as proponents say the chemicals bind to calcium in the arterial plaque, removing them and opening up the vessels. Other outcomes to be studied include the reduction in cholesterol levels, decrease in arterial inflammation, and possible improvement to blood vessel function. Results are not expected until 2012.
The FDA warning letters were sent to the following companies who have 15 working days to respond to the FDA. Failure to address the violations can result in fines, confiscation of the products, or criminal prosecution.
• 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 Chelate (H-870)
The FDA asks patients and doctors to report any undesirable side effects or adverse events related to these chelation products to www.fda.gov/MedWatch/report.htm