APMA recommends Health Enterprises product for runners
BETHESDA, Md. The American Podiatric Medical Association recently issued a series of recommendations for runners, including the use of a self-massager designed for post-athletic activities. Specifically, the association recommended Health Enterprises’ therapeutic hot-and-cold foot massager, a product that carries the APMA seal of approval.
"Some of the most common running-related foot injuries that today’s podiatrists treat are arch pain, tendonitis and blisters," stated APMA president Kathleen Stone. “However, if runners can take just a few minutes to stretch properly pre-workout, select appropriate footwear and see a podiatrist immediately when foot pain occurs, many of these ailments can be avoided entirely.”
Other recommendations made by APMA included selecting a good running shoe, selecting good socks and stretching for five to 10 minutes prior to a run. Frequent runners should see a podiatrist on a regular basis to maximize any running program and prevent serious injury, the association added.
FDA issues warning over unapproved OTC chelation products
SILVER SPRING, Md. The Food and Drug Administration on Thursday warned eight companies that their over-the-counter 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 FDA confirmed.
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. 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,” stated 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 only available by prescription 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,” noted Dara Corrigan, associate commissioner for Regulatory Affairs.
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: Detoxamin oral, Detoxamin suppositories, and the metal detector test kit;
- Hormonal Health and World Health Products: Kelatox suppositories, and the MetalDetector instant toxic metals test;
- Evenbetternow: 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 Labs: 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: CardioRenew and CardioRestore;
- Artery Health Institute: Advanced Formula EDTA oral chelation;
- Longevity Plus: Beyond chelation improved, EndoKinase, Viral Defense, Wobenzym-N; and
- Dr. Rhonda Henry: Cardio Chelate (H-870)
JAMA article points to pharmacy’s role in MTM, improved patient care system
ALEXANDRIA, Va. The drumbeat in support of an expanded, universally recognized role for pharmacists in helping patients successfully manage their drug therapy is getting steadily louder.
The latest note of support comes from the chief voice of the nation’s physician community, the Journal of the American Medical Association. In an Oct. 13 article, JAMA points to community pharmacists as a key resource to help bridge the gap between doctor and patient, particularly for patients treated by more than one specialist in an often disconnected and dysfunctional health care network.
The article, titled “Medication Use in Older Patients: Better Policy Could Encourage Better Practice,” was hailed by the National Association of Chain Drug Stores Thursday as “further validation of the need for public policy to embrace pharmacists’ expertise in helping patients take their medications correctly.” What’s more, notes the group, the points made by JAMA author Jerry Avorn, MD, are “consistent with NACDS’ ongoing campaign to raise awareness of … medication adherence to help boost health and reduce healthcare costs.”
Avorn highlights both the critical value of drug therapy and the need for accessible, community-based health professionals, such as pharmacists and nurses, to augment a more effective, patient-centric health system. “The use of medications in older patients,” he wrote, “is arguably the single most important health care intervention in the industrialized world.” However, he noted that “dys-organization” in healthcare delivery is “particularly problematic for complex patients with several chronic conditions who take multiple medications, often provided by numerous specialists in little or no contact with one another — a recipe for pharmacological chaos.”
Avorn “specifically mentions pharmacists as a solution,” NACDS pointed out. “Although the 2010 healthcare legislation did not reform the delivery system, it did provide for small pilot studies of ‘medical homes’ that could address the fragmentation of care that so often defeats the provision of integrated, coherent drug regimens for elderly patients with complex health care needs,” the author writes. “Solutions could be designed-in as these systems develop in several ways. Pharmacists and nurses could work with physicians to develop, implement, and monitor drug regimens.”
NACDS president and CEO Steven Anderson found plenty to like with that approach. “NACDS is 100-percent committed to unleashing the power of pharmacy to help improve lives and to reduce the estimated $290 billion in annual costs — 13% of all healthcare expenditures — related to not taking medications correctly,” he said. “This effort is resulting in consistent progress, such as the advancement of pharmacist-provided medication therapy management that provides a methodical approach to increasing medication adherence.”
To that end, noted Anderson, “The article in the Journal of the American Medical Association is yet another drumbeat that should continue to inspire action for further progress in public policy.”