Ann Allergy Asthma Immunol. 2002 Oct;89(4):400-6.Author information1Department of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA. Riegert.douglas@mayo.eduAbstractBACKGROUND: Phytonadione (vitamin K1) administered intravenously (i.v.) has been associated with anaphylaxis, although the incidence is not known. The anaphylaxis is thought to be attributable to the solubilizing vehicle, polyethoxylated castor oil (Cremophor EL, BASF AG, Ludwingshafen, Germany).OBJECTIVE: To estimate the incidence of anaphylaxis after i.v. administration of phytonadione.METHODS: A retrospective review of anaphylaxis after i.v. phytonadione over a 58-month period at a large academic center was performed. During the period of the study a protocol for the administration of i.v. phytonadione was in place. A review of computerized records and survey of staff identified cases of anaphylaxis meeting predefined inclusion criteria. In addition, a literature review was performed for articles concerning anaphylaxis after i.v. phytonadione.
RESULTS: Over the 58 months of the study, a total of 6,572 doses of i.v. phytonadione were administered. Two cases of anaphylaxis after i.v. phytonadione were identified. The incidence of anaphylaxis was 3 per 10,000 doses with 95% confidence intervals of 0.04 to 11 per 10,000 doses. The literature review identified 14 cases meeting inclusion criteria with no reviews of the literature or estimates of incidence.CONCLUSIONS: The incidence of anaphylaxis after i.v. phytonadione is overall comparable or slightly less than other drugs known to cause anaphylaxis. We do not recommend routine pretreatment with antihistamines or corticosteroids before administration of phytonadione.PMID: 12392385 DOI: 10.1016/S1081-1206(10)62042-X [Indexed for MEDLINE] Publication typesCase ReportsReviewMeSH termsAdultAgedAged, 80 and overAnaphylaxis/chemically induced*Anaphylaxis/epidemiology*ChildFemaleHumansIncidenceInjections, IntravenousMaleMiddle AgedRetrospective StudiesVitamin K 1/adverse effects*SubstanceVitamin K 1Full Text SourcesElsevier ScienceOvid Technologies, Inc.MedicalAnaphylaxis - MedlinePlus Health InformationMiscellaneousPHYTONADIONE - Hazardous Substances Data Bank
The Trauma Professional's Blog Vitamin K has gotten a bad rap for years. There have been rumors of anaphylactic reactions to IV administration since I can remember. In the very old days, it was discovered that the vehicle used to deliver it (a variant of castor oil) was the likely culprit. But even after the vehicle was changed, rumors persisted. This led to the recommendation that Vitamin K be given subq or orally back in the 1990s. Even after 20 years, the reluctance to give it IV is still there.In trauma, we need things fast. If someone has critical bleeding because they are taking warfarin, we want to begin reversing it quickly. And although the desired effects of Vitamin K may take hours to achieve, oral and subq absorption in trauma patients can be variable. IV is usually the way to go. So is IV Vitamin K such a bad thing?A number of analyses and meta-analyses have been completed on this topic. A fairly comprehensive one looked at the literature over 30 years, and also reviewed the FDA’s adverse reaction database.
The literature review found 23 cases of anaphylactic reaction, 3 of which were fatal. The FDA database uncovered 132 patients over a 30 year period, of which 24 were fatal.Remember, that’s 1 case per year in the literature and 4 per year in the FDA database. Now let’s put it into perspective. The overall incidence of anaphylaxis in the US is about 50 to 2000 episodes per 100,000, with about 1500 deaths annually. Induction of anesthesia results in about 10-15 anaphylactic events per 100,000, with the majority from neuromuscular blockers. Bottom line: Anaphylaxis is possible with anything that we ingest or inject! Anaphylaxis after IV Vitamin K administration is rare, estimated to be about 4 per 100,000. This is incredibly low. Many pharmacies stipulate that it be given by slow IV push (over 30 minutes), but anaphylaxis has been seen at lower doses and even with slow IV push. If your patient needs Vitamin K, don’t be reluctant to give it intravenously. Your patient is more likely to have a reaction from latex than from this medication.
As with any drug, though, always monitor your patient for adverse reactions. References:Anaphylactoid reactions to Vitamin K. J Thromb Thrombolysis 11(2):175-183, 2001.Epidemiology of anaphylaxis: findings of the American College of Allergy, Asthma and Immunology Epidemiology of Anaphylaxis Working Group. Ann Allergy Asthma Innunol 97(5):596-602, 2006. Blog comments powered by This PDF is available to Subscribers Only Sign in as individual > Sign in as institution >J Matern Fetal Neonatal Med. 2014 Jul;27(11):1180-1. Epub 2013 Oct 17.Koklu E1, Taskale T, Koklu S, Ariguloglu EA.Author information1Division of Neonatology, Megapark Hospital , Kahramanmaraş , Turkey .AbstractNewborn infants are born with an immature innate immunity. They are less likely to develop anaphylaxis since their immune system is weaker than older infants and children. There are only a few reports of side effects after vitamin K injection in neonates although prophylaxis against hemorrhagic disease of the newborn with this drug has been in routine practice in all over the world for many years.
We herein report a case of anaphylactic shock developing after the intramuscular administration of vitamin K1 in a newborn. To our knowledge, this patient is the first case of neonatal anaphylactic shock developing due to intramuscular administration of vitamin K1. We suggest the clinicians should be aware of this possibility of potentially fatal adverse effect occurring with intramuscular administration of vitamin K1.vitamin KPMID: 24059412 DOI: 10.3109/14767058.2013.847425 [Indexed for MEDLINE] Publication typesCase ReportsReviewMeSH termsAnaphylaxis/chemically induced*Anaphylaxis/congenitalCerebral Hemorrhage/congenitalCerebral Hemorrhage/prevention & controlFemaleHumansInfant, NewbornInfant, Newborn, Diseases/chemically induced*Injections, IntramuscularMalePregnancyVitamin K/administration & dosageVitamin K/adverse effects*Young AdultSubstanceVitamin KFull Text SourcesTaylor & FrancisMedicalAnaphylaxis - MedlinePlus Health InformationCommon Infant and Newborn Problems - MedlinePlus Health InformationUncommon Infant and Newborn Problems - MedlinePlus Health InformationVitamin K - MedlinePlus Health Information