My September 29, 2020, Email to Baxter Healthcare Ltd Re: Dextrose IV Fluid

Email to Baxter Healthcare Ltd: medinfo_ukl@baxter.com

Re:  Labeling of IV solution to which corn sugar (dextrose) has been added
https://www.medicines.org.uk/emc/product/1825/smpc

In our corn allergy support groups of over 12K members, the primary complaint is the lack of knowledge by medical professionals about the critical difference between glucose (blood sugar present in all living organisms) and dextrose (corn sugar manufactured from cornstarch).  One physician told a corn-allergic patient that "No one can be allergic to dextrose" and another physician told a corn-allergic patient that "No one can be allergic to dextrose, because dextrose is naturally present in our bodies."  Both of these physicians administered IV fluids to these patients to which corn sugar (dextrose) had been added, in direct violation of the contraindication warning in the package insert, resulting in anaphylactic reactions requiring emergency intervention.  

Glucose (blood sugar present in all living organisms) cannot provoke an allergic response; whereas, dextrose (corn sugar manufactured from cornstarch) can prove fatal to anyone with an IgE-mediated allergy to corn. For this reason, IV solutions to which corn sugar (dextrose) has been added contain contraindication warnings for administration to corn-allergic patients.

August 6, 2020, Call to Baxter Healthcare Ltd.
A member of one of our corn allergy groups who resides in the U.K. just discovered that corn sugar (dextrose) IV fluid sold outside of the United States by Baxter Healthcare Ltd is labeled as “Glucose 5% Intravenous Infusion BP.”  It is clearly corn sugar (dextrose) IV fluid, since the product information sheet does include contraindication warnings for administration to corn-allergic patients.  Since glucose is blood sugar, physicians may not realize that this product is actually corn sugar (dextrose) IV fluid, thus potentially endangering the lives of corn-allergic patients.

I placed an emergency call to Baxter Quality Control Department, 1-800-437-5176; and they are taking this matter very seriously.  They are expediting our concerns about the labeling of this product.  I also forwarded corn allergy documentation to them, @baxter_intl, in addition to @Datapharm for their review and consideration.
https://www.medicines.org.uk/emc/product/1825/smpc

We, the corn allergy population of the world, are appealing to Baxter Healthcare Ltd. to immediately correct the labeling of this product for our safety.  Glucose (blood sugar present in all living organisms) is NOT a drug product; therefore, it shouldn't be labeled as such.  

Thank you for your attention to this critical concern.

Diane H, Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

References

Instructions for reporting medical professionals who administer corn sugar (dextrose) IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert.
LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Glucose (blood sugar) must NEVER be equated with dextrose (corn sugar manufactured from cornstarch).
[This petition does NOT solicit donations.]

PETITION: Defund the NIH National Library of Medicine for Willful Negligence
https://www.change.org/p/united-states-department-of-health-human-services-defund-the-nih-national-library-of-medicine-for-willful-negligence

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM
https://cornallergyadvocacyresources.blogspot.com/2020/06/pharmacists-confirm-study-of-nmis-non.html

"Probable anaphylactic reaction to corn-derived dextrose solution."
https://www.ncbi.nlm.nih.gov/pubmed/1808842

BCPharmacists, "Warning: corn-related allergens . . ."
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

Baxter Labs specifically warns about administering dextrose IV fluids to corn-allergic patients.
 "Solutions containing dextrose should be used with caution, if at all, in patients with known allergy to corn or corn products." - Page 3
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf

CORN SUGAR (DEXTROSE) IV FLUIDS CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

 

Blog Post Link: 

My September 29, 2020, Email to Baxter Healthcare Ltd Re: Dextrose IV Fluid
https://cornallergyadvocacyresources.blogspot.com/2020/09/my-september-29-2020-email-to-baxter.html