Vitamin K1 Injection Contains Corn Sugar (Dextrose); [NO CONTRAINDICATION WARNING]

          Dextrose is corn sugar manufactured from cornstarch. [1] Therefore, Lactated Ringer’s with 5% Dextrose Solution is contraindicated for corn-allergic patients [2,3].  Since Vitamin K₁ injection solution contains dextrose, why is it not contraindicated for corn-allergic patients, particularly since reported deaths have resulted from the administration of Vitamin K₁ injection solution? Therefore, it is probable that some of these deaths were the result of an anaphylactic reaction to dextrose (the sugar derived from corn).

            In corn allergy support groups of nearly 12K members, many of these members are parents of corn-allergic infants/children, many of whom are anaphylactic to corn and corn-derived ingredients [4].  Therefore, it is imperative that Vitamin K₁ injection solutions, and all other injectable solutions with dextrose, contain a contraindication warning for administration to corn-allergic patients. In addition, it appears that this solution may contain other ingredients derived from corn or formulated using a corn medium; e.g., corn oil. [5]

            “Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose (emphasis added), hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0).

            BOXED WARNING

WARNING — INTRAVENOUS AND INTRAMUSCULAR USE

Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. (emphasis added).  Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.” [6]

Corn is considered a “major allergen” in many published corn allergy studies.[7]

Diane H., Corn Allergy Advocate

Corn Allergy Advocacy/Resources

https://cornallergyadvocacyresources.blogspot.com/

Email:  cornallergyinitiative@gmail.com

Twitter:  @CornAllergy911

References:

[1] Corn Sugar (Dextrose/D-Glucose), Code of Federal Regulation 21CFR184.1857

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

[2] LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

[3] PROBABLE ANAPHYLACTIC REACTION TO CORN-DERIVED DEXTROSE SOLUTION

https://www.ncbi.nlm.nih.gov/pubmed/1808842

[4] “Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17

https://responsibletechnology.org/wp-content/uploads/2017/06/Corn-Products-Derivatives-06-06-17.pdf

[5] Oral Challenge of Mazola Corn Oil to Test Hypothesis Presented by Dr. Phil Lieberman

[Thankfully, the AAAAI removed this opinion paper from their website.]

https://cornallergyadvocacyresources.blogspot.com/2017/12/oral-challenge-of-mazola-corn-oil-to.html

[6] VITAMIN K₁- phytonadione injection, emulsion

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e8808230-2c44-44c6-8cab-8f29b6b34051

[7] Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)

https://cornallergyadvocacyresources.blogspot.com/2017/05/published-corn-allergy-studies.html

Blog Post Reference:

Vitamin K₁ Injection Contains Corn Sugar (Dextrose); [NO CONTRAINDICATION WARNING]
https://cornallergyadvocacyresources.blogspot.com/2020/01/vitamin-k1-injection-contains-corn.html