Thursday, December 18, 2014

FDA warns consumers against OTC chelation products

Parents of children with autism or relatives of people with Alzheimer's or Parkinson's sometimes turn to so-called chelation products purchased on the internet and elsewhere to treat these serious health conditions. Chelation products are intended to remove heavy metal from the body, but Thursday the Food and Drug Administration warned consumers that there are no such products approved for over-the-counter sale.

FDA warns consumers against OTC chelation products

Parents of children with autism or relatives of people with Alzheimer’s or Parkinson’s sometimes turn to so-called chelation products purchased on the internet and elsewhere to treat these serious health conditions.

Chelation products are intended to remove heavy metal from the body, but Thursday the Food and Drug Administration warned consumers that there are no such products approved for over-the-counter sale.

Moreover, the federal agency warned that there are “serious safety issues associated with chelation products, which 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 it has seen a rise in “chelation therapy” products being sold on the Internet. Often sold as dietary supplements, these chemicals are really unapproved drugs that claim to treat diseases. The products come in various forms ranging from sprays and suppositories to pills, drops and “clay baths.”

On Tuesday October 12, the FDA issued warning letters to eight companies, telling them to cease the improper sale of these products or face legal action.

The FDA issued such letters to the following companies:

  • Artery Health Institute, LLC of New York, New York
  • Cardio Renew, Inc of Apple Valley, Minnesota
  • Dr. Rhonda Henry of Dayton, Nevada
  • Evenbetternow, LLC of Oro Valley, Arizona.
  • Hormonal Health, LLC and World Health Products, LLC of San Bernardino, California
  • Longevity Plus of Payson, Arizona
  • Maxam Nutraceutics/Maxam Laboratories of Hood River, Oregon
  • World Health Products, LLC of Draper, Utah

“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 the 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.”

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Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Dual Board Certified Anesthesiologist and Surgical Intensivist
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