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
