Q:How safe and effective are oral vitamin K preparations? W L, Boston....
A:Even if they don't believe Golding's findings, Britain and Germany have rushed to embrace the oral variety of vitamin K as an acceptable alternative. The British Department of Health now recommends that doctors switch to the oral variety for low-risk infants, with a dose at birth, a further dose a week later and a third dose six weeks after birth to those babies who are breastfed (formula contains vitamin K).
However, there is now some question as to whether the oral variety works. In a recent study in Germany, of 20 babies who went on to develop HDN, only two hadn't received any vitamin K, and 13 had received the oral type according to the three-step guidelines (although in five cases, the third dose had been overlooked). In total, 10 of the 14 babies who developed HDN after the sixth week had received all three doses. However, 16 of the 20 had some physical problem most often fat absorption or liver malfunction, which may have had more to do with their problem than a missing third dose (BMJ, April 29, 1995).
Two researchers from the Clinical pharmacology division of drug company Hoffman La Roche pooled the German cases with 27 British cases of HDN reported between 1988 and 1990. They concluded that two doses were probably adequate for babies breastfed for only a month and three doses for two months, but for any longer, more doses were probably needed (The Lancet, August 13, 1994).
Doctors have assumed that the injectable variety is more effective because a "depot" is formed at the injection site, from which the vitamin is gradually released. But the evidence suggests that even with the injectable variety, protection doesn't last. In one study of exclusively breastfeeding babies, eight of the 63 given injected vitamin K at birth had evidence of concentrations of a substance in the blood considered to be a marker of bleeding risk (BMJ, 1991; 303: 1105-9).
The final difficulty is that neither the UK nor the US has licensed an oral preparation for babies. At the moment, doctors are using unlicensed preparations, one reason why worried mothers are refusing to comply with the recommended doses. A new "mixed-micelle" formulation for oral use is in the process of being reviewed for licensing to babies, but a good deal of experimentation will have to be done to find the most effective and safe dosage of the new drug (The Lancet, May 7, 1994). A number of doctors are screaming for a long-term study into the safety of vitamin K, but doctors are reluctant to pursue it because they believe it would be unethical to deprive all newborns of the vitamin.
If you are reluctant to have your baby given an injectable vitamin with such question marks surrounding it and he is low-risk of HDN, make sure to specify this before you give birth. Many babies are whisked away for a "routine" check-up and given the jab without your consent. Then make sure to feed your baby right after birth and frequently during the first days so he gets a good amount of colostrum. Thereafter, ensure that you have an adequate intake of vitamin K.
The most important thing to look for is one of a number of types of warning bleeds, such as unexplained bruising, nose bleeds or oozing of blood from the umbilical stump. This can often prefigure a brain hemorrhage, and if you act upon a warning promptly and get vitamin K, you are likely to prevent the massive bleeding. Also, if your baby is still jaundiced at two to three weeks, it may be wise to consider an underlying liver problem (BMJ, April 2, 1994). If you do wish to have the oral vitamin K, you can either follow DoH guidelines or opt to have your baby get further tiny supplements.