To: Center for Biologics Evaluation & Research (CBER), ocod@fda.hhs.gov
Re: Dextrose
As
your organization is aware, dextrose is the chemical name for corn sugar
produced from allergenic cornstarch, 21CFR184.1857; and is, therefore,
contraindicated for administration to corn-allergic patients in the package
insert accompanying corn sugar (dextrose/D-glucose)-containing IV fluids since
these IV fluids contain allergenic corn proteins.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
Based on the testimonies from the 17K+ members
in corn allergy support groups, clinicians are telling corn-allergic patients
that "Dextrose is naturally present in the human body." I
reported a clinician who was prepping me for surgery after she made this statement,
since dextrose can prove fatal to corn-allergic patients with an IgE-mediated
allergy to corn. The hospital mailed me a letter confirming they held a
department-wide meeting to educate all hospital clinicians that dextrose (corn
sugar/D-glucose)-containing IV fluids are contraindicated for administration to
corn-allergic patients in the package insert. Corn-allergic patients
will no longer tolerate our clinicians telling us that our IgE-mediated
allergen (corn) is "naturally present" in our body.
Many members in our corn allergy support groups
are corn-allergic clinicians, and they have expressed dismay and
disgust that they, themselves, were never taught in their respective
disciplines that dextrose is corn sugar produced from allergenic
cornstarch. They were taught that "dextrose is sugar water."
To which United States government agency may we
direct our certified letter requesting confirmation, in writing, that
dextrose is corn sugar that is only produced from cornstarch which is
contraindicated for administration to corn-allergic patients that we can
present to our clinicians confirming this fact?
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
Documentation:
"Dextrose-containing solutions pose a significant risk to patients
allergic to corn. Dextrose used for IV fluids is prepared by the simple
hydrolysis of cornstarch."
https://journals.lww.com/anesthesia-analgesia/Fulltext/2019/05000/Excipients_in_Anesthesia_Medications.11.aspx
"Solutions containing dextrose should be used with caution, if at all, in
patients with known allergy to corn or corn products.
D-Glucopyranose monohydrate"
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf
"Pharmacists are requested to use caution and be aware that many drugs and
medications contain undisclosed potential allergens in the form of sugars,
starches, and celluloses. Share the corn allergy example with
prescribers . . ." [emphasis added]
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf
"These types of fluids usually contain dextrose, a simple sugar
made from corn, [emphasis added] that can be used at higher rates to treat
diabetics going through severe hypoglycemia."
https://www.ivwatch.com/2021/06/18/whats-in-my-iv-a-deep-dive-on-the-many-types-of-iv-fluids/
"Corn is all around us and is used even in health care products! Patients
with low blood sugar are often given IV drips, many of which contain dextrose,
a corn derivative." [emphasis added]
https://corn.org/cra-newsletter-mar-4-2022/
The European Medicines Agency also confirms dextrose is ONLY derived from
corn.
"Dextrose a sugar that is obtained from corn starch"
"Dextrans come from corn and potato starch; dextrose comes from
corn."
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf
"Corn must first be converted to corn sugar (dextrose, the common
commercial name for D-glucose) . . ."
https://polymerinnovationblog.com/from-corn-to-poly-lactic-acid-pla-fermentation-in-action/
“Dextrose is an ALL-American sugar, derived from American corn, refined in
American factories, distributed by American companies.”
FACT: Dextrose can prove FATAL to anyone w/an IgE-mediated allergy to corn.
https://candyprofessor.wordpress.com/2010/09/29/dextrose-all-american-corn-sugar/
Glucose = blood sugar essential for survival of all living organisms.
D-Glucose = synthetic, man-made, laboratory-created form of glucose produced
from cornstarch (dextrose).
L-Glucose = synthetic, man-made, laboratory-created form of glucose.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
Code of Federal Regulation 21CFR184.1857:
Corn sugar produced from cornstarch:
Corn sugar = dextrose = D-glucose
Corn sugar = D-glucose = dextrose
Dextrose = corn sugar = D-glucose
Dextrose = D-glucose = corn sugar
D-glucose = corn sugar = dextrose
D-glucose = dextrose = corn sugar
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857
Blog Post Reference:
My
May 31, 2022, Email to the FDA’s Center for Biologics and Evaluation &
Research (CBER) Re: Dextrose
https://cornallergyadvocacyresources.blogspot.com/2022/05/my-may-31-2022-email-to-fdas-center-for.html
