For many desperate patients, over-the-counter chelation treatments used for conditions including autism, heart disease and Alzheimer’s disease, among others, offered hope for a cure. Now the Food and Drug Administration (FDA) is cracking down on the makers of such products, saying they are dangerous and illegal.
The FDA sent warning letters to eight makers of chelators — drugs that remove heavy metals from the body — to stop marketing the drug for medical uses for which it has not been approved, a violation of federal law. The products, which are widely marketed and available on the Internet, may cause serious and potentially deadly health complications, including dehydration and kidney failure. Many companies that sell chelators also sell metal toxicity tests, which encourage people to test their levels and, in turn, may boost chelator sales. The Washington Post reports:
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.”
Some parents of autistic kids, for instance, claim that heavy-metal poisoning is a cause of autism and that chelators help affected children. There is no medical evidence to support that claim. However, there is evidence that the products can be dangerous: according to the Centers for Disease Control and Prevention, a 5-year-old autistic boy died of a heart attack while being given an intravenous chelation treatment at his doctor’s office in 2005. The same year, a 2-year-old girl in Texas suffered the same fate. (More on Time.com: Top 10 Product Recalls)
Several of the eight companies contacted by the FDA responded with dismay, saying the treatment has been around for more than a decade and is beneficial to many. Failure to address the federal violations, however, can result in fines, confiscation of the products or criminal prosecution.
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