My May 31, 2022, Email to the FDA’s Center for Biologics and Evaluation & Research (CBER) Re: Dextrose

 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