Drugs

FDA warns consumers about potential health risks from using Thorne Research’s Captomer products

[6/12/14] The U.S. Food and Drug Administration is warning consumers not to purchase or to use Thorne Research’s Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children.

 
FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. Procedures involving chelation agents carry significant risks and should be performed only under medical supervision. 
 
There are no FDA-approved OTC chelation products. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload.
 
Thorne Research has agreed to voluntarily recall the products. For recall information, contact Thorne Research.
 
The company has received several adverse event reports associated with these products. FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Safety Information and Adverse Event Reporting program:
 
 
Chelation therapy has been used to remove excess or toxic heavy metals from the body.

 

Captomer labeling

 Captomer-250 labeling

 

Page Last Updated: 11/30/2015
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