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)

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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Updated NCCN Guidelines for Breast Cancer Discourages Prophylactic Mastectomy in Women Other Than Those at High Risk

/PRNewswire/ -- Despite a recent study finding that an increasing number of women who had cancer in one breast are opting to have the other breast removed, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology(TM) for Breast Cancer discourages prophylactic mastectomy in women except for those considered high risk. This recommendation is noted in the recently updated NCCN Guidelines for Breast Cancer along with a new regimen for adjuvant chemotherapy and recommendations for utilizing sentinel node mapping and excision in women with clinically negative lymph nodes.

In the updated NCCN Guidelines, it states that prophylactic mastectomy (the removal of a noncancerous breast) contralateral to a known unilateral breast cancer is not recommended except as outlined in the NCCN Guidelines for Genetics/Familial High-Risk Assessment: Breast and Ovarian and the NCCN Guidelines for Breast Cancer Risk Reduction. When prophylactic mastectomy is being considered, the NCCN Guidelines note that the small benefits must be balanced with the risk of recurrent disease from the known breast cancer, the psychological and social issues associated with bilateral mastectomy, and the overall risks of contralateral mastectomy.

The practice of removing noncancerous breasts to reduce the risk or prevent cancer has become increasingly common among women. A study recently published in the journal Cancer found that among women who had cancer in one breast, the number who opted to have the other breast removed, more than doubled from 1995 through 2005 in New York state. However, there is no data to demonstrate that having prophylactic mastectomy actually improves survival.

The NCCN Guidelines Panel suggests that high-risk women considering a prophylactic mastectomy should be evaluated by a multi-disciplinary team and counseled on the risks of the procedure.

Perhaps the most clinically important update to the NCCN Guideline is the removal of the recommendation for a full axillary lymph node dissection as an option for women with clinically negative lymph nodes. The updated NCCN Guidelines now recommend that women with stage one or two invasive breast cancer with clinically negative lymph nodes, undergo sentinel node mapping and excision provided they are being treated by a team of clinicians with experience in sentinel node biopsy.

Sentinel node biopsy is a diagnostic procedure used to determine whether breast cancer has metastasized to axillary lymph nodes (e.g., lymph nodes under the arm). Sentinel node biopsy requires the removal of only a few lymph nodes compared to a full axillary lymph node dissection, and may decrease the risk of lymphedema and pain associated with surgery.

Another important update to the NCCN Guidelines is the addition of a new regimen for adjuvant chemotherapy for invasive breast cancer. The NCCN Guidelines now include FEC [fluorouracil (Adrucil(R), Pfizer Inc.) / epirubicin (Ellence(R), Pfizer Inc.) / cyclophosphamide (Cytoxan(R), Bristol-Myers Squibb Company)] followed by weekly paclitaxel (Taxol(R), Bristol-Myers Squibb Company) as an option for adjuvant therapy, treatment given after surgery.

Although the incidence of breast cancer has increased steadily in the United States over the past few decades, breast cancer mortality appears to be declining suggesting a benefit from early detection and more effective treatment.

NCCN Clinical Practice Guidelines in Oncology(TM) are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.

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Hearsay: How to remove a tick

A School Nurse has written the info below -- good enough to share -- And it really works!!

I had a pediatrician tell me what she believes is the best way to remove a tick.. This is great, because it works in those places where it's some times difficult to get to with tweezers: between toes, in the middle of a head full of dark hair, etc.

Apply a glob of liquid soap to a cotton ball. Cover the tick with the soap-soaked cotton ball and swab it for a few seconds (15-20), the tick will come out on its own and be stuck to the cotton ball when you lift it away. This technique has worked every time I've used it (and that was frequently), and it's much less traumatic for the patient and easier for me.

Unless someone is allergic to soap, I can't see that this would be damaging in any way.

I even had my doctor's wife call me for advice because she had one stuck to her back and she couldn't reach it with tweezers. She used this method and immediately called me back to say, "It worked!"

Note: We received the above via email and have not tried it. According to all we've read, the only safe way to remove a tick is with tweezers, etc. If you try this and it works, let us know!

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AUA Guideline: Full Kidney Removal Not Necessary for All Kidney Tumors

/PRNewswire/ -- Radical nephrectomy (complete removal of the affected kidney) is not the best treatment for most small kidney tumors because it puts patients at risk for chronic kidney disease and cardiovascular disease. Nephron-sparing treatments, such as partial nephrectomy, thermal ablation and active surveillance, minimize these risks and are viable options for patients with early-stage kidney tumors, according to a new clinical guideline issued by the American Urological Association (AUA). The guideline was released on Tuesday, April 28, 2009 during the Association's Annual Scientific Meeting in Chicago.

This is the first time that the AUA has released official guidelines for the management of patients with kidney cancer. This guideline is focused on the management of patients with early-stage renal masses, which has become controversial in the past few years. Guideline Panel Co-Chair Steven C. Campbell, MD, PhD, will present the guideline to the media on April 28, 2009 at 12:30 p.m. in the AUA Press Suite, located at the Hyatt Regency McCormick in Chicago.

Detection of clinical stage 1 (<7.0>3 to 4 cm) should be managed in a proactive manner, if possible.

Radical Nephrectomy: Radical nephrectomy is still occasionally required. A laparoscopic approach should be considered because it is associated with a more rapid recovery profile.

The Guideline Panel also addressed the following novel treatment modalities: high-intensity focused ultrasound, radiosurgery, microwave thermotherapy; laser interstitial thermal therapy; and pulsed cavitational ultrasound.

The "Guideline for Management of the Clinical Stage 1 Renal Mass" will be published in The Journal of Urology(R) later this year. A press conference on the Guideline will be held on April 28, 2009 at 12:30 p.m. at the Hyatt Regency McCormick Place during the AUA Annual Meeting in Chicago, IL. For more information on covering the press conference or to schedule an interview, please contact Lacey Dean at LDean@AUAnet.org.

Panel Members included: Steven C. Campbell, MD, PhD, Co-Chair; Arie Belldegrun, MD; Michael L. Blute, MD; George Kuoche Chow, MD; Ithaar H. Derweesh, MD; Jihad H. Kaouk, MD; Raymond J. Leveille, MD; Surena F. Matin, MD; Paul Russo, MD; Robert Guy Uzzo, MD; and the late Andrew C. Novick, MD.

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