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Entries in Center for Drug Evaluation and Research (1)

Thursday
Oct142010

Chelation Quackery? FDA Moves to Halt Supplements

Photo Courtesy - Getty Images(NEW YORK) -- The U.S. Food and Drug Administration recently warned eight companies to cease marketing of over-the-counter products which they claim will treat everything from autism and Alzheimer's to macular degeneration, MedPage Today reports.

The products, known as chelation products, are marketed as dietary supplements which the FDA does not regulate.  The products are generally sold in various forms such as nasal sprays, capsules, liquid drops and suppositories.

"This is dangerously misleading, targeting patients and caregivers of patients who have serious conditions with limited treatment options," Michael Levy, director of new drugs and labeling compliance at the FDA's Center for Drug Evaluation and Research (CDER), said during a press briefing.

The products claim to cure a range of diseases by removing heavy metals from the body.  These conditions including autism and cardiovascular conditions, as well as Parkinson's, Alzheimer's, and macular degeneration.

Though no adverse events have yet been reported, Dr. Charles Lee, medical officer at CDER, said the products can cause side effects including dehydration, kidney failure, liver damage and death.

"Just because we don't have evidence of lots of adverse events doesn't mean there's no risk from them," Lee said, adding that such events are likely underreported.

Many parents have turned to intravenous chelation to treat their autistic children -- treatment that is not FDA-approved, MedPage Today reports.  The agency said it is aware of one death in an autistic child given intravenous chelation therapy.

The agency said it does not have data as to how widespread is the use of the over-the-counter agents.

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