Vitamin K for the Prevention of Bleeding in Newborns

Marcia L. Buck, PharmD, FCCP

Pediatr Pharm. 2001;7(10) 

In This Article

The Controversial Link to Cancer

In the early 1990s, Golding and colleagues from Southwestern England first suggested that IM vitamin K administration might be associated with an increased risk of childhood cancer.[12,13] In their retrospective study, a group of 180 children with cancer were evaluated with a cohort of 507 healthy children.[13] The odds ratio was 2.65 (98% confidence interval 1.34 to 5.24) for acute lymphocytic leukemia and 1.97 (confidence interval 1.04 to 2.84) for all forms of cancer. The mechanism for this association was suggested from in vitro studies where the presence of IM vitamin K induced single and double-strand DNA breaks, increasing sister chromatid exchanges, and the knowledge that IM administration often leads to initial serum concentrations 10,000 times higher than endogenous levels.

Several papers have challenged this association. The Golding study was limited by its small sample size and lack of consistent methods for vitamin K administration. In a larger cohort study, Ekelund and colleagues evaluated over 1 million infants born in Sweden between 1973 and 1989.[14] In this study, 2,354 children were diagnosed with cancer. Analysis of the patients revealed no difference in cancer rates between children receiving IM and oral vitamin K. The odds ratio was 0.90 (95% confidence interval 0.70 to 1.16) for leukemia and 1.01 (confidence interval 0.88 to 1.17) for all cancers.

In September 1993, Klebanoff and coworkers from the National Institutes of Health published the results of their nested cohort study using prospective controls.[15] This trial identified 48 cases of childhood cancer among 54,795 children in the Collaborative Perinatal Project from 1959 through 1966. Vitamin K had been administered to 68% of the 44 cases available for evaluation and in 71% of the 228 matched controls. The odds ratio was 0.47 (95% confidence interval 0.14 to 155) for leukemia and 1.08 (confidence interval 0.45 to 2.61) for all cancers. The authors concluded that there was no clear association between IM vitamin K administration and childhood cancer, although a slight increase in risk could not be ruled out. When weighing the benefits of preventing VKDB versus this risk, they suggested that routine prophylaxis not be abandoned.

Several other studies have also refuted the link between IM vitamin K and cancer. In a review of the evidence available to date, Ross and Davies evaluated ten case-controlled studies, seven of which found no relationship and three that found only a weak relationship between the use of parenteral vitamin K and leukemia.[16] In addition, a small in vivo study of infants given vitamin K found no increase in sister chromatid exchanges.[17] While this information has provided a degree of assurance for the safety of IM administration, concerns over the potential risk remained. Publication of the Golding papers has led some practitioners to abandon the IM preparation and institute oral dosing regimens for vitamin K prophylaxis.

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