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U.S. Food and Drug Administration
Information for healthcare consumers about the safety of medication and medical devices
FDA Warns Marketers of Unapproved ‘Chelation’ Drugs
 Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease.
The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.
FDA compliance expert Deborah Autor says the companies are preying on people made vulnerable because of serious illness.
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” says Autor.
In letters dated Oct. 14, FDA warns the companies that they are facing possible legal action if they continue to make unsubstantiated claims. The firms that received the letters (along with the chelation products they market) are:
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FDA 101: Medication Errors
 A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. Since 2000, the Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. FDA reviews reports that come to MedWatch6, the agency's adverse event reporting program.
"These reports are voluntary, so the number of actual medication errors is believed to be higher," says Carol Holquist, R.Ph., Director of the Division of Medication Error Prevention and Analysis in FDA's Center for Drug Evaluation and Research.
FDA works with many partners to track medication errors, including the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). "Every report received through the USP/ISMP Voluntary Medication Error Reporting Program (MERP) automatically gets sent to FDA's MedWatch program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It takes a cooperative approach to monitor errors, evaluate them, and educate the public about strategies to keep errors from happening again."
Medication errors occur for a variety of reasons. For example, miscommunication of drug orders can involve poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units.
"Medication errors usually occur because of multiple, complex factors," says Holquist. "All parts of the health care system—including health professionals and patients—have a role to play in preventing medication errors."
FDA's Role
- Drug Name Review:
To minimize drug name confusion, FDA reviews about 400 drug names a year that companies submit as proposed brand names. The agency rejects about one-third of the names that drug companies propose.
- Drug Labels:
FDA regulations require all over-the-counter (OTC) drug products (more than 100,000) to have a standardized "drug facts label." FDA has also improved prescription drug package inserts for health care professionals.
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