Adverse events associated with vitamin K1: Results of a worldwide postmarketing surveillance programme

Pharmacoepidemiology and Drug Safety

Volumn 7, Issue 3, 1998, Pages 173-182

  Pereira, Stephen P ^a   Williams, Roger ^b  

^a GUY S HOSPITAL   (United Kingdom)

^b ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

Author keywords

Adverse drug reactions; Konakion( ); Phylloquinone; Phytomenadione; Postmarketing surveillance; Vitamin K

Indexed keywords

CREMOPHOR; PHYTOMENADIONE;

ANAPHYLAXIS; ARTICLE; DRUG FORMULATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HUMAN; MAJOR CLINICAL STUDY; PRIORITY JOURNAL;

EID: 0031840421     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1099-1557(199805/06)7:3<173::AID-PDS343>3.0.CO;2-8     Document Type: Article

References (58)

1. Shearer, M. J. Vitamin K. Lancet 1995; 345: 229-234.
2. Havel, M., Muller, M., Graninger, W., Kurz, R. and Lindemayr, H. Tolerability of a new vitamin K1 preparation for parenteral administration to adults: one case of anaphylactoid reaction. Clinical Therapeutics 1987; 9: 373-379.
3. Barash, P., Kitahata, L. M. and Mandel, S. Acute cardiovascular collapse after intravenous phytonadione. Anesthesia and Analgesia 1976; 55: 304-306.
4. Anderson, T. H., Hindsholm, K. B. and Fallingborg, J. Severe complication to phytomenadione after intramuscular injection in woman in labor. Case report and review of literature. Acta. Obstetrica. et. Gynecologica. Scandinavica. 1989; 68: 381-382.
5. Watkins, J. The allergic reaction to intravenous induction agents. British Journal of Hospital Medicine 1986; 36: 45-48.
6. Sanders, M. N. and Winkelmann, R. K. Cutaneous reactions to vitamin K. Journal of the American Academy of Dermatology 1988; 19: 699-704.
7. Tuppal, R. and Tremaine, R. Cutaneous eruption from vitamin K1 injection. Journal of the American Academy of Dermatology 1992; 27: 105-106.
8. de la Rubia, J., Grau, E. Montserrat, I., Zuazu, I. and Paya, A. Anaphylactic shock and vitamin K1. Annals of Internal Medicine 1989; 110: 943.
9. Lemlich, G., Green, M., Phelps, R., Lebwohl, M., Don, P. and Gordon, M. Cutaneous reactions to vitamin K1 injections. Journal of the American Academy of Dermatology 1993; 28: 345-347.
10. Rich, E. C. and Drage, C. W. Severe complications of intravenous phytonadione therapy: two cases, with one fatality. Postgraduate Medicine 1982; 72: 303-306.
11. Hopkins, C. S. Adverse reaction to a Cremophorcontaining preparation of intravenous vitamin K. Intensive Therapy and Clinical Monitoring 1988; 9: 254-255.
12. Glen, J. B. and Hunter, S. C. Pharmacology of an emulsion formulation of ICI 35 868. British Journal of Anaesthesia 1984; 56: 617-626.
13. Lorenz, W., Schmal, A., Schult, H. et al. Histamine release and hypotensive reactions in dogs by solubilizing agents and fatty acids: analysis of various components in cremophor E1 and development of a compound with reduced toxicity. Agents and Actions 1982; 12: 64-80.
14. Ennis, M., Lorenz, W. and Gerland, W. Modulation of histamine release from rat peritoneal mast cells by non-cytotoxic concentrations of the detergents Cremophor E1 (oxethylated castor oil) and Triton XlOO. A possible explanation for unexpected adverse drug reactions? Agents and Actions 1986; 18: 235-238.
15. Ennis, M., Lorenz, W., Kapp, B., Luben, L. and Schmal, A. Comparison of the histamine-releasing activity of cremophor E1 and some of its derivatives in two experimental models: the in vivo anaesthetized dog and in vitro rat peritoneal mast cells. Agents and Actions 1985; 16: 265-268.
16. Lorenz, W. Local and systemic tolerance of a new parenteral formulation of vitamin K (Ro 01-6722/ 120) based on bile salt mixed micelles. Agents and Actions 1975; 5: 402.
17. Teelmann, K., Schlappi, B., Schupbach, M. and Kistler, A. Preclinical safety evaluation of intravenously administered mixed micelles. Arzneimittelforschimg 1984; 34: 1517-1523.
18. Grüter, J. Comparative bioavailability and kinetics of KONAKION MM oral and parenteral in infants suffering from chronic cholestasis. Roche Research Report 1991; No. B-115'050.
19. Schubiger, G., Tonz, O., Gruter, J. and Shearer, M. J. Vitamin K1 concentration in breast-fed neonates after oral or intramuscular administration of a single dose of a new mixed-micellar preparation of phylloquinone. Journal of Pediatric Gastroenterology and Nutrition 1993; 16: 435-439.
20. Schubiger, G., Grüter, J. and Shearer, M. J. Plasma vitamin K1 and PIVKA-II after oral administration of mixed-micellar or cremophor EL-solubilized preparations of vitamin K1 to normal breast-fed newborns. Journal of Pediatric. Gastroenterology and Nutrition 1997; 24: 280-284.
21. Amédée-Manesme, O., Lambert, W. E., Alagille, D. and De Leenheer, A. P. Pharmacokinetics and safety of a new solution of vitamin K1(20) in children with cholestatis. Journal of Pediatric Gastroenterology and Nutrition 1992; 14: 160-165.
22. Cornelissen, E. A., Kollee, L. A., De Abreu, R. A. et al. Effects of oral and intramuscular vitamin K prophylaxis on vitamin K1, PIVKA-II, and clotting factors in breast fed infants. Archives of Disease in Childhood 1992; 67: 1250-1254.
23. Park, B. K., Scott, A. K., Wilson, A. C., Haynes, B. P. and Breckenridge, A. M. Plasma disposition of vitamin K1 in relation to anticoagulant poisoning. British Journal of Clinical Pharmacology 1984; 18: 655-662.
24. Shearer, M. J., McBurney, A. and Barkhan, P. Studies on the absorption and metabolism of phylloquinone (vitamin K1) in man. Vitamins and Hormones 1974; 32: 513-542.
25. Dankwa, E. Review on adverse events associated with phytomenadione (vitamin K1), Konakion all formulations: period 1st July 1994 to 30th June 1995. Roche Research Report 1995; No. B-165-734.
26. Dankwa, E. Review on adverse events associated with Konakion all formulations: period 1 January 1952 to 30 June 1994. Roche Research Report 1994.
27. van der Klauw, M. M., Stricker, B. H., Herings, R. M. Cost, W. S., Valkenburg, H. A. and Wilson, J. H. A population based case-cohort study of drug-induced anaphylaxis. British Journal of Clinical Pharmacology 1993; 35: 400-408.
28. Anonymous. Fatal case report. Swedish Medical Journal 1988; 85: 1705.
29. Dorr, R. T. Pharmacology and toxicology of Cremophor EL diluent. Annals of Pharmacotherapy 1994; 28: S11-S14.
30. Abraham, J. S., Bentley, F. R., Garrison, R. N. and Cryer, H. M. The influence of the cyclosporine vehicle, cremophor EL, on renal microvascular blood flow in the rat. Transplantation 1991; 52: 101-105.
31. Clarke, R. S. Adverse effects of intravenously administered drugs used in anaesthetic practice. Drugs 1981; 22: 26-41.
32. Clarke, R. S. Clinical features and changing trends in hypersensitivity reactions. Annales Fransaises d'Anesthesie Reanimation. 1985; 4: 146-151.
33. Dye, D. and Watkins, J. Suspected anaphylactic reaction to Cremophor EL. British Medical Journal 1980; 280: 1353.
34. Thijssen, H. H. and Drittij Reijnders, M. J. Vitamin K status in human tissues: tissue-specific accumulation of phylloquinone and menaquinone-4. British Journal of Nutrition 1996; 75: 121-127.
35. Weir, M. R., Klassen, D. K., Shen, S. Y., Sullivan, D., Buddemeyer, E. U. and Handwerger, B. S. Acute effects of intravenous cyclosporine on blood pressure, renal hemodynamics, and urine prostaglandin production of healthy humans. Transplantation 1990; 49: 41-47.
36. Bowers, V. D., Locker, S., Ames, S., Jennings, W. and Corry, R. J. The hemodynamic effects of Cremophor-EL. Transplantation 1991; 51: 847-850.
37. Lorenz, W., Reimann, H. J., Schmal, A. et al. Histamine release in dogs by Cremophor E1 and its derivatives: oxethylated oleic acid is the most effective constituent. Agents and Actions 1977; 7: 63-67.
38. Mann, R. D. and Rawlins, M. D. Spontaneous adverse drug reaction reporting systems. In: A Textbook of Pharmaceutical Medicine: Current Practice. Mann, R. D., Rawlins, M. D. and Auty, R. M. (Eds). Parthenon Publishing Group, Carnforth, Lancs, UK, 1993; pp. 323-330.
39. Fletcher, A. P. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. Journal of the Royal Society of Medicine 1991; 84: 341-344.
40. Golding, J., Paterson, M. and Kinlen, L. J. Factors associated with childhood cancer in a national cohort study. British Journal of Cancer 1990; 62: 304-308.
41. Golding, J., Greenwood, R., Birmingham, K. and Mott, M. Childhood cancer, intramuscular vitamin K, and pethidine given during labour. British Medical Journal 1992; 305: 341-346.
42. Carstensen, J. Intramuscular vitamin K and childhood cancer. British Medical Journal 1992; 305: 709-710.
43. Draper, G. J. and Stiller, C. A. Intramuscular vitamin K and childhood cancer. British Medical Journal 1992; 305: 709.
44. Hilgartner, M. W. Vitamin K and the newborn. New England Journal of Medicine 1993; 329: 957-958.
45. Rennie, J. M. and Kelsall, A. W. Vitamin K prophylaxis in the newborn - again. Archives of Disease in Childhood 1994; 70: 248-251.
46. Zipursky, A. Vitamin K at birth. British Medical Journal 1996; 313: 179-180.
47. Ekelund, H., Finnstrom, O., Gunnarskog, J., Kallen, B. and Larsson, Y. Administration of vitamin K to newborn infants and childhood cancer. British Medical Journal 1993; 307: 89-91.
48. Klebanoff, M. A., Read, J. S., Mills, J. L. and Shiono, P. H. The risk of childhood cancer after neonatal exposure to vitamin K. New England Journal of Medicine 1993; 329: 905-908.
49. Olsen, J. H., Hertz, H., Blinkenberg, K. and Verder, H. Vitamin K regimens and incidence of childhood cancer in Denmark. British Medical Journal 1994; 308: 895-896.
50. Ansell, P., Bull, D. and Roman, E. Childhood leukaemia and intramuscular vitamin K: findings from a case-control study. British Medical Journal 1996; 313: 204-205.
51. von Kries, R., Gobel, U., Hachmeister, A., Kaletsch, U. and Michaelis, J. Vitamin K and childhood cancer: a population based case-control study in Lower Saxony, Germany. British Medical Journal 1996; 313: 199-203.
52. McKinney, P. A., Juszczak, E., Findlay, E. and Smith, K. Case-control study of childhood leukaemia and cancer in Scotland: findings for neonatal intramuscular vitamin K. British Medical Journal 1998; 316: 173-177.
53. Passmore, S. J., Draper, G., Brownbill, P. and Kroll, M. Ecological studies of relation between hospital policies on neonatal vitamin K administration and subsequent occurrence of childhood cancer. British Medical Journal 1998; 316: 184-189.
54. Parker, L., Cole, M., Craft, A. W. and Hey, E. N. Neonatal vitamin K administration and childhood cancer in the north of England: retrospective case-control study. British Medical Journal 1998; 316: 189-193.
55. Passmore, S. J., Draper, G., Brownbill, P. and Kroll, M. Case-control studies of relation between childhood cancer and neonatal vitamin K administration. British Medical Journal 1998; 316: 178-184.
56. Croucher, C. and Azzopardi, D. Compliance with recommendations for giving vitamin K to newborn infants. British Medical Journal 1994; 308: 894-895.
57. Grüter, J. Efficacy and tolerability of Konakion MM Ro 01-6722/135 1 mg vitamin K1 i.v. and 2 mg vitamin K1 p.o. in the prophylactic treatment against hamorrhagic disease in premature infants. Roche Research Paper 1993; No. B-162'002.
58. Baeniziger, O., Braegger, C. P. and Fanconi, S. Oral vitamin K prophylaxis for newborn infants: safe enough? Lancet 1996; 348: 1456.