3/1/2012 Chelation News: FDA issues warnings to marketers of unapproved ‘chelation’ products

The U.S. Food and Drug Administration today warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.

 

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. 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 drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). 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.

 

In addition, 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.  

 

“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s 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 advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.

 

The FDA has noted 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 products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.

 

Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.

 

"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.

 

Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.

 

The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:

• World Health Products, LLC: Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit
• Hormonal Health, LLC and World Health Products, LLC: Kelatox Suppositories, and the METALDETECTOR Instant Toxic Metals Test
• Evenbetternow, LLC: Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and the Heavy Metal Screen Test
• Maxam Nutraceutics/Maxam Laboratories: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test
• Cardio Renew, Inc: CardioRenew and CardioRestore
• Artery Health Institute, LLC: Advanced Formula EDTA Oral Chelation
• Longevity Plus: Beyond Chelation Improved, EndoKinase, Viral Defense, Wobenzym-N
• Dr. Rhonda Henry: Cardio Chelate (H-870)

FDA Warns Companies Promoting Chelation Products

The FDA is cracking down against the makers of over-the-counter chelation products which are claimed to  help remove toxic metals from the body. These are often sold over the net. Manufacturers say they are are valid treatment for conditions like autism, heart disease, macular degeneration, and Alzheimer's disease, by linking toxic metals to these conditions. 

On Thursday, the FDA issued eight warning letters to companies marketing chelation products, saying that claims about using such products to treat medical conditions violate federal law. "What we're telling consumers is that any chelation therapy marketed over the counter is suspect," Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, said during a briefing with reporters. 


The FDA has approved some chelation products to be prescribed in cases of heavy metal poisoning, but - here is the key -  none are approved for sale over the counter or on  the Internet.

What you see most often is a chelation product marketed as a dietary supplement, with varying dosages and forms, including capsules, liquid drops, and sprays. If not used properly, or without proper warning, the products could cause dehydration, kidney failure, or death, according to the FDA. The agency says it issued the warnings in response to increased product promotion and availability to consumers. If the companies don't correct the violations detailed in the letters, their products could be seized.

More here.http://health.usnews.com/health-news/managing-your-healthcare/bones-joints-and-muscles/articles/2010/10/15/health-buzz-fda-warns-against-the-use-of-chelators.html  

Meridia and Heart Problems?

The New England Journal of Medicine (NEJM) has found that among nearly 10,000 overweight or obese patients, those who used Meridia had a 16% greater risk of having a heart attack or stroke over an average 3.4 years than patients taking a placebo. None of the events were fatal, but the finding was especially worrisome since the trial included only patients with a previous history of heart disease or diabetes, or both, which put them at high risk of a second event. Being overweight, they were also already at a higher risk of heart-related health problems.


A study was commissioned by the European Union's European Medical Agency, after initial studies of Meridia users, conducted prior to 2002, found that the drug raised blood pressure and pulse rates, both well known risk factors for heart disease. When Meridia, which suppresses appetite by regulating the brain chemicals serotonin and norepinephrine, was approved for use in the U.S. in 1997, the FDA included a warning about these risks on the label.

Read more: http://www.time.com/time/health/article/0,8599,2015619,00.html#ixzz0yKq0tzz1

Read more: http://www.time.com/time/health/article/0,8599,2015619,00.html#ixzz0yKprSrjQ

Does Chelation Therapy Cause Heart Injuries?

Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany; kidney damage; decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.