FDA warns companies promoting products used in chelation procedures
Friday, October 15, 2010
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. Patients are infused with compounds that bind to the metals, enabling the metals 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 various names, dosages and forms, including suppositories, capsules, liquid drops, sprays and clay baths.
"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," said Deborah Autor, director of the FDA's office of compliance in the 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."
The warning letters were sent to: World Health Products; Hormonal Health; Evenbetternow; Maxam Nutraceutics/Maxam Laboratories; Cardio Renew; Artery Health Institute; and Dr. Rhonda Henry.
Butch Svedeen, a spokesman for World Health Products, said the company was "surprised . . .about even receiving the letter, and obviously we will do whatever it takes to comply with the FDA." The others either could not be reached or declined to comment.
A 2007 survey of alternative medical use in the United States conducted by the Centers for Disease Control and Prevention found that 111,000 people 18 and older used chelation therapy in the previous 12 months.
The National Institutes of Health is sponsoring a large study to test whether the chelation agent EDTA is safe and effective for people 50 and older with heart disease. The theory is that EDTA chelation might work by removing calcium in fatty plaques that block arteries, by lowering cholesterol levels or by reducing inflammation in the arteries and improving blood vessel function. None of the ideas has been well tested in scientific studies. The results of the NIH study are expected in 2012.