Chelation Products and Unapproved Over-the-Counter Drugs

The US FDA advises consumers to avoid “chelation” products, over-the-counter (OTC) for prevention or treatment of diseases because they can cause serious harm and/or death.

Background of Over-the-Counter Chelation drugs

Chelation is used to remove heavy metals from the body via certain chemicals. Some of these products are marketed as dietary supplements but they are unapproved drugs for treatment of diseases.

FDA Alert on Over-the-Counter Chelation drugs

The FDA has not approved any chelation product for Over-The-Counter use. All FDA-approved chelation products require a prescription.

When taking an unapproved OTC chelation drug, effective medical care may be delayed. Even under medical supervision these products may cause kidney failure, dehydration and death.

Recommendation on Over-the-Counter Chelation drugs

“The agency advises consumers to avoid non-prescription products offered for chelation or detoxification.”

Contacting the FDA to report cases with Over-the-Counter Chelation drugs

In case of detection of adverse events or side effects related to the use of Over-the-Counter Chelation drugs, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.