The Food and Drug Administration is cracking down on chelation therapies, an alternative treatment marketed for autism, Parkinson’s and Alzheimer’s that focuses on cleansing the body.
In a series of letters posted on the agency’s website, the FDA warned eight companies marketing chelation drugs and devices that the products are “unapproved” by the agency and that making unproven claims about them violates federal law.
Chelation therapies, which focus on removing heavy metals from the body, are widely marketed on the Internet as an alternative treatment for debilitating diseases. The treatments are marketed in a variety of forms, from clay baths to sprays.
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, who works in the FDA’s 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.”
In addition to the allegations of false claims, the FDA also says that consumers of chelation therapies put themselves at risk for a variety of side effects, such as dehydration and kidney failure, or even death.
“We don’t have evidence of a lot of adverse events, but [that] does not mean there are not health problems associated with them,” Charles Lee, an FDA official, told The Washington Post. “Chelation can be dangerous and cause serious harm.”
According to the Post, the FDA is aware of the death of one autistic child who underwent a chelation procedure, but officials say they think that serious complications are greatly underreported.
For decades doctors have used chelation to treat patients exposed to dangerous levels of heavy metals, such as in cases of lead poisoning, the newspaper reported. 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, the agency said, are available with a prescription and should be used by a trained medical professional because of the risks.
