FDA advisory against Over the Counter Chelation Therapy

"Home Chelation Therapy" can potentially cause liver and/or kidney damage, and death

FDA Alert:
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 have 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 pursuing 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.