Wednesday, October 7, 2020

My October 7, 2020, Email to the FDA and NIH National Library of Medicine Re: Dextrose IV Fluids

 CRITICAL UPDATE, DECEMBER 5, 2020

Since sending this email to the FDA and the NIH National Library of Medicine, Rxlist.com has revised their definition of dextrose (corn sugar manufactured from cornstarch, 21CFR184.1857) from a "glucose-elevating agent" to an "antidote" with no contraindication warning for administration to corn-allergic patients.  This revised definition of dextrose not only endangers the lives of corn-allergic patients, but also exposes physicians to potential liability if they prescribe/administer dextrose-containing drug/biologic products to corn-allergic patients, even though no contraindication warning is indicated in the package insert.  Dextrose (corn sugar) is, in fact, a blood sugar (glucose)-elevating agent.

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To:  NLM Support, nlm-support@nlm.nih.gov
NLM Communications, NLMCommunications@nlm.nih.gov
PubChem Central, pubmedcentral@ncbi.nlm.nih.gov
CDER DRUG INFO, druginfo@fda.hhs.gov

Dextrose is a "Glucose-Elevating Agent" - Rxlist.com

Since dextrose (corn sugar manufactured from cornstarch) is a "glucose-elevating agent," how can these two distinct forms of sugar have the same molecular formula?

Dextrose is a "Glucose-Elevating Agent."
https://www.rxlist.com/consumer_dextrose/drugs-condition.htm

Dextrose Molecular Formula C6H14O7
PubChem CID: 66370
https://pubchem.ncbi.nlm.nih.gov/compound/DEXTROSE

Corn Syrup Molecular Formula C6H14O7
PubChem CID: 5282499
https://pubchem.ncbi.nlm.nih.gov/compound/Corn-syrup

Cornstarch Molecular Formula C27H48O20
PubChem CID: 24836924
https://pubchem.ncbi.nlm.nih.gov/compound/24836924

Therefore, how can corn sugar manufactured from cornstarch be assigned molecular formula C6H12O6?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1857

Again, how can corn sugar and blood sugar be "one and the same," particularly since blood sugar found naturally in all living organisms (glucose) cannot provoke an allergic response; whereas, corn sugar manufactured from cornstarch (dextrose) can prove fatal to anyone with an IgE-mediated allergy to corn?  

In my interview with my primary care physician on September 30, 2020, he could not answer this question.  In addition, he admitted that he did not know that dextrose is corn sugar manufactured from cornstarch; and was unaware that IV fluids to which corn sugar (dextrose) has been added are contraindicated for administration to corn-allergic patients in the package insert. 

Since this could result in a liability issue for physicians, I have been forwarding this critical documentation to medical malpractice insurers.  It took me three years to forward the package insert accompanying dextrose IV solutions to our nation's hospitals, colleges of medicine, and colleges of pharmacy; however, we continue to receive reports from the 12K+ members in our corn allergy support groups that the contraindication warning is being ignored by medical staff. 
It is my hope that medical malpractice insurers will also forward this critical information not only to protect medical professionals from potential liability, but also for the protection of corn-allergic patients from this critical medical error.

In the meantime, I have shared the following blog post with corn allergy group members in addition to applicable global contacts; e.g., European Union and Canadian hospitals/agencies, etc.   

Guidelines 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

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


Additional Reference:

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

 

Blog Post Reference Link:

My October 7, 2020, Email to the FDA and NIH National Library of Medicine Re: Dextrose IV Fluids
https://cornallergyadvocacyresources.blogspot.com/2020/10/my-october-7-2020-email-to-fda-and-nih.html

 

 

 

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