FDA cracks down on chelation therapy drugs

Washington Post

Washington Post Staff Writer
Friday, October 15, 2010; 12:01 AM

Federal health officials on Thursday announced a crackdown on a controversial therapy widely hawked on the Internet and elsewhere as an alternative treatment for conditions such as autism, Alzheimer’s disease and Parkinson’s disease by “cleansing” the body.

The Food and Drug Administration said it has sent warning letters to several companies notifying them that the substances they sell without a prescription for a procedure known as “chelation” are “unapproved drugs and devices,” which makes them illegal.

The agency became alarmed about the growing promotion and easy availability of the products because the substances may cause serious health complications, including dehydration and kidney failure, and possibly be deadly, officials said. The agency is aware of the death of one autistic child who underwent the procedure, but officials say they think that serious complications are greatly underreported.

“We don’t have evidence of a lot of adverse events, but [that] does not mean there are not health problems associated with them,” said Charles Lee of the FDA’s division of new drugs and labeling compliance at the center for drug evaluation and research. “Chelation can be dangerous and cause serious harm.”

For decades, doctors have used chelation to treat patients exposed to dangerous levels of heavy metals, such as in cases of lead poisoning. Patients are infused with compounds that bind to the metals, enabling them to be excreted. But the only chelation products that have been approved by the FDA are available with a prescription and should be used by a trained medical professional because of the risk of complications, the FDA said.

The companies that received the warning letters sell products without a prescription, often as “dietary supplements,” and describe multiple health benefits, none of which have been proven, the agency said. The products have been promoted particularly heavily to parents of autistic children. The products have various names, dosages and forms, including suppositories, capsules, liquid drops, sprays and clay baths.

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