Consumer Health Digest #13-44

Your Weekly Update of News and Reviews
November 21, 2013

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

Bleeding reported in infants whose parents declined vitamin K injections. Four cases of severe bleeding have been reported in infants whose parents did not permit them to get the vitamin K injection that is routinely administered at birth. [Warren M and others. Late vitamin K deficiency bleeding in infants whose parents declined vitamin K prophylaxis—Tennessee, 2013. MMWR 62:901-902, 2013] The parents of these children said they did not think the shot was necessary, wanted to minimize exposure to "toxins," and were concerned that the injections might increase the risk of leukemia. Vitamin K is needed to synthesize a compound that is needed for blood clotting. Infants are born with low stores and need supplementation until they can get adequate intake from food and intestinal bacteria that synthesize it. An injection shortly after birth gives 100% protection during the vulnerable period. Orally administered vitamin K is nearly as effective, but not 100%. Those who receive no external vitamin K are at greater risk for bleeding. [American Academy of Pediatrics Committee on Fetus and Newborn. Controversies concerning vitamin K and the newborn. Pediatrics 112:101-102, 2003] The authors of the case report found that 3.4% of 3,080 infants born in one of three Nashville area hospitals surveyed and 28% of 218 infants born in four Tennessee non-hospital birthing centers did not receive intramuscular vitamin K after birth. When asked whether the parents of the children who hemorrhaged had been offered oral vitmin B, one of the investigators replied:

No, none of the children received oral vitamin K. Parents, in general, were not aware that oral vitamin K could be an option. It is not something offered as a standard alternative to the injection. There are multiple issues with oral vitamin K. First and foremost, the surveillance coming out of Europe on vitamin K deficiency bleeding tells us that oral vitamin K is not as effective as the single IM dose. There are multiple regimens for oral vitamin K, with the most effective requiring multiple doses. Multiple doses are problematic in some practical ways, since parents need to give doses for weeks or months, depending on the regimen, and in some physiologic ways, since absorption of enough vitamin K to prevent bleeding depends on the functionality of the neonatal/infantile gut, which varies from infant to infant. Additionally, oral vitamin K has not been well-evaluated for infants at additional risk of vitamin K deficiency bleeding because of malabsorption or liver diseases. In addition to these issues, oral vitamin K is not FDA-approved for infants, and so this would be off-label use—which is not in and of itself a problem, but given that (a) it isn't normally used for infants and (b) the injection is routine and highly effective, most pediatricians are unfamiliar with its use, and the most effective oral regimen is far from agreed upon. Parents of three healthy children we spoke to during this investigation gave their children oral vitamin K, but each of these are using different formulations and regimens, and they have all done this on their own, without the involvement of their pediatricians.

Herbal product investigation finds scandalous results. Researchers who used DNA barcoding—a type of genetic "fingerprinting"—to test herbal products have reported widespread discrepancies between the ingredients listed on the label and those found in the products. The study encompassed 44 products representing 12 companies and 30 different species of herbs. The researchers concluded:

The researchers recommended that the herbal industry should embrace DNA barcoding for authenticating herbal products. [Newmaster SG and others. DNA barcoding detects contamination and substitution in North American herbal products. BMC Medicine 11:222, 2013] Even if quality control is improved, however, the widespread problems of ineffectiveness and inferiority to prescribed drugs will remain. [Barrett S. The herbal minefield. Quackwatch, Nov 23, 2013]

ZNatural ad debunked. Dr. Stephen Barrett has posted a detailed investigative report on ZNatural, a zeolite-based mineral supplement whose sellers claimed "might wipe out the cause of 75% of your health problems." When the product was advertised in his local newspaper, he asked the newsroom to write about why the advertising department was willing to accept such an ad. The paper's vice president for display advertising replied that they had relied on a trusted advertising agency to vet the ad but will suspend publishing of similar ads that "serve no useful purpose and could be misleading to readers."

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This page was revised on November 26, 2013.