FDA cracks down on experimental autism therapy
Federal health officials are cracking down on a controversial therapy that has been promoted as an alternative for a variety of conditions, including autism, Alzheimer's disease and Parkinson's disease.
The Food and Drug Administration warned eight companies Thursday that their over-the-counter products used for a procedure known as "chelation" are "unapproved drugs and devices" and so are in "violation of federal law."
"The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson's disease, Alzheimer's disease, macular degeneration and other serious conditions," the agency said. "Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy."
The drugs involved have not been evaluated by the FDA for treatment of these diseases, and therefore violate the Federal Food, Drug and Cosmetic Act, the FDA said.
"Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care," the FDA said.
The drug can have serious safety risks, the agency said, because the agents can "alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death," the FDA said.
"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 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 agency advised consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available only by prescription and approved for use in specific indications such as lead poisoning and iron overload.
The FDA took the action after noticing "an increase in 'chelation therapy' products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease," the FDA said. "The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths."
"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness," said Dara A. Corrigan, associate commissioner for regulatory affairs.
The companies that received the warning letters are:
-- World Health Products, LLC
-- Hormonal Health, LLC and World Health Products, LLC
-- Evenbetternow, LLC
-- Maxam Nutraceutics/Maxam Laboratories
-- Cardio Renew, Inc.
-- Artery Health Institute, LLC
-- Dr. Rhonda Henry
The 2007 National Health Interview Survey, conducted by the Centers for Disease Control and Prevention, found that 111,000 adults 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 over with heart disease. EDTA stands for ethylene diamine tetra-acetic acid, which is a synthetic amino acid that is delivered intravenously. The treatment is not approved for heart disease, but some doctors are using it. The results are expected in 2012.
The theory is that EDTA chelation might work by directly removing calcium found in fatty plaques that block arteries, causing the plaques to break up, that the process may stimulate the release of a hormone that in turn causes calcium to be removed from the plaques or causes a lowering of cholesterol levels. Another theory is it may reduce the damaging effects of oxygen ions (oxidative stress) on the walls of the blood vessels. Reducing oxidative stress could reduce inflammation in the arteries and improve blood vessel function. None of these theories has been well tested in scientific studies.
| October 14, 2010; 1:09 PM ET
Categories: Alternative and Complementary Medicine, Autism, Cardiovascular Health, FDA, Kids' health, Popular Procedures
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