An Important Message from the U.S. Food & Drug Administration (FDA)

The US Food and Drug Administration FDA advises consumers to be wary of
so-called “chelation therapy” capsules, tablets, or suppositories
marketed over-the-counter (OTC) that are promoted for home use to
prevent or treat diseases. Various forms of “chelation” therapies are
purported to cleanse the body of chemicals (such as mercury-containing
chemicals) or to improve the cardiovascular system. “Chelation” has been
proposed as a treatment for autism or hardening of the arteries; and for
many other serious conditions.
Many of these products are promoted on the internet.
FDA has never approved any marketing application for a nonprescription
oral or rectal chelation product. Such products have not been studied in
adequate and well-controlled clinical trials, and clinical data
sufficient to support either the safety or efficacy of drugs used for
these “chelation” purposes has not been reviewed by FDA. These products
are illegally marketed and have not been subject to the rigorous
manufacturing scrutiny required for FDA-approved products. FDA is
concerned about the potential direct health risks posed by these
products because of the lack of safety information, and because serious
side effects can occur when a “chelation” product is used without the
oversight of a licensed health-care professional. The products also pose
serious indirect health risks to patients using these products that may
be foregoing effective conventional medical treatment.

Families of children and adults with autism spectrum disorders are
encouraged to speak to their health-care professional about treatment
options, including pursing new therapies with clinical investigators
engaged in research monitored under an Institutional Review Board
approved Investigational New Drug application, to make sure the risks
are as low as possible and are worth any potential benefits.