In
our corn allergy support groups of 16K+ members, we continue to receive reports
of medical staff administering Lactated Ringer’s in 5% dextrose IV fluids to
corn-allergic patients in direct violation of the contraindication warning in
the package insert, even though I spent three years forwarding this
documentation to our nation’s hospitals, [1] colleges of medicine, [2] and colleges
of pharmacy. [3]
Dextrose is corn sugar manufactured from cornstarch
per Code of Federal Regulation 21CFR184.1857; [4] therefore, glucose (blood sugar) is not dextrose (corn sugar) and dextrose
(corn sugar) is not glucose (blood
sugar). [5,6] There are
publications claiming that these two distinct forms of sugar (one natural; one
manufactured) are "biochemically identical" (Molecular Formula:
C6H12O6)]; [7] however, not with regard to their allergenicity; i.e., dextrose
(corn sugar manufactured from cornstarch) can prove fatal to anyone with an IgE-mediated
allergy to corn. [8,9] It is for this
reason that IV fluids to which corn sugar (dextrose) has been added are
contraindicated for administration to corn-allergic patients; [10] however,
these contraindication warnings remain inconsistent. [11,12]
If corn sugar (dextrose/D-glucose)-containing IV fluid is administered
to you, particularly if your allergy to corn is clearly documented in your
medical records, please report the incident as follows:
1. Submit a
Patient Safety Event Report with The Joint Commission.
https://www.jointcommission.org/en/resources/patient-safety-topics/report-a-patient-safety-event/
https://www.jointcommission.org/en/resources/patient-safety-topics/report-a-patient-safety-event/
2. File a
Patient Safety Event Report with the state health department in which the
medical facility is located.
3. Obtain the
name of the person who administered the dextrose IV fluid, and file a complaint
with their state licensing board. They
are also required to report this medical error. [13]
4. File a
Patient Safety Event Report with the administrator of the medical facility
where the incident occurred.
5. Demand that
they pull the package insert accompanying Lactated Ringer’s in 5% dextrose IV
fluid. If they cannot locate this
package insert, immediately document this incident; and demand that they sign a
statement that the package insert is unavailable for review. While contacting our nation’s hospitals, a
CEO of one hospital informed me that the package insert accompanying dextrose
IV fluid was destroyed. She then instructed the supply department to provide
her with the package insert on their next shipment of Lactated Ringer’s dextrose
IV fluid.
6. Consider
consulting with legal counsel, since Lactated Ringer’s in 5% Dextrose IV fluids
are clearly contraindicated for administration to corn-allergic patients in the
package insert. In addition, medical professionals are required to verify the
"source" of all excipients prior to prescribing/administering
drug/biologic products to their patients with IgE-mediated allergies, even if
no contraindication warning is present on the drug label. [14-20]
CRITICAL
QUESTION:
What option is available for treating an unconscious corn-allergic patient experiencing a hypoglycemic episode, when corn sugar (dextrose/D-glucose)-containing IV fluids can prove fatal to the patient due to their IgE-mediated allergy to corn?
Diane H., Corn
Allergy Advocate
Corn Allergy
Advocacy/Resources
Twitter: @CornAllergy911
References:
[1] United
States Hospitals/Health Systems Contacted Re: Protocol for Treating
Corn-Allergic Patients
https://cornallergyadvocacyresources.blogspot.com/2017/07/united-states-hospitalshealth-systems.html
[2] Colleges of
Medicine Contacted Re: Protocol for Treating Corn-Allergic Patients
[3] Colleges of
Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients
[4] CORN SUGAR (DEXTROSE),
CODE OF FEDERAL REGULATION 21CFR184.1857
[5] Dextrose:
Facts vs. Fiction
[6] My March 5,
2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation
21CFR184.1857, vs. Glucose (Blood Sugar)
[7] My July 2,
2020, Appeal to the NIH National Library of Medicine Re: PubChem CID 79025,
Glucose (Blood Sugar) vs. Dextrose (Corn Sugar Derived from Cornstarch)
https://cornallergyadvocacyresources.blogspot.com/2020/07/my-july-2-2020-appeal-to-nih-national.html
[8] Probable
anaphylactic reaction to corn-derived dextrose solution
“. . . clinicians should be aware of the possibility
of corn allergy due to the administration of i.v. fluids containing
corn-derived dextrose.”
Guharoy SR, Barajas M. Probable anaphylactic reaction
to corn-derived dextrose solution. Vet Hum Toxicol. 1991;33(6):609-610.
[9] BCPharmacists,
"Warning: corn-related allergens . . ."
College of Pharmacists of British Columbia, Warning:
corn-related allergens, Non-medicinal ingredients don’t appear on drug labels,
ReadLinks, May/June 2007, Vol. 32, No. 3
[10] CORN SUGAR
(DEXTROSE) IV FLUIDS CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
[11] PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED
FOR CORN-ALLERGIC PATIENTS
[12] Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION
WARNING]
[13] Chapter 35
Error Reporting and Disclosure
[14] ALLERGIC TO
YOUR MEDICATION: WHAT YOUR DOCTOR SHOULD KNOW
“Doctors should have your medical history, including
all known allergies, on file. OF course, many patients aren’t aware of the full
extent of their drug allergies, so it is important that a doctor discloses to
their patient what the drug is they’re prescribing and whether it has known
side-effects or might cause an allergic reaction.”
https://novak-law.com/allergic-to-your-medication-what-your-doctor-should-know/
A $10 million allergy case: Could it happen to you?
https://www.medicaleconomics.com/view/10-million-allergy-case-could-it-happen-you
A $10 million allergy case: Could it happen to you?
https://www.medicaleconomics.com/view/10-million-allergy-case-could-it-happen-you
[15] "Inactive" ingredients in oral medications
[16] 93
percent of medications contain 'potential allergens'
[17] My June 2, 2020, Email to the World Allergy Organization
(WAO) Re: Prescribing Drug/Biologic Products to Patients with IgE-Mediated
Allergies to Excipients
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-2-2020-email-to-world-allergy.html
[18] My June 5, 2020, Email to the FDA Re: Emergency Mandate
Requiring Contraindication Warnings be Listed for Drug/Biologic Products Based
on the "Source of Excipients"
[19] My June 16, 2020, Email to the FDA Re: Corn Labeling in
Drug/Biologic Products
[20] My June 24, 2020, Email to the FDA and CDC Addressing
Contraindication Warnings for Drug/Biologic Products Based on the Source of
Excipients
IMPORTANT NOTATION REGARDING MY APPEAL TO BAXTER
HEALTHCARE CORPORATION
I contacted the Quality Control Department of Baxter Healthcare Corporation on December 16, 2019, 1-800-437-5176, appealing to them to add a corn allergy warning ON THE PRODUCT, since hospital personnel continue to administer dextrose IV fluids to corn-allergic patients, even though their corn allergy is clearly documented in their medical records. The representative with whom I spoke indicated that he would bring this to the attention of their Quality Control Department.
UPDATE:
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
Additional
References:
Dextrose is the chemical name for corn sugar manufactured from cornstarch/D-glucose, 21CFR184.1857, and can prove fatal to anyone with an IgE-mediated allergy to corn.
https://cornallergyadvocacyresources.blogspot.com/2021/06/dextrose-is-corn-sugar-21cfr1841857-and.html
Published
Corn Allergy Studies/Statistics (“. . .
Maize major allergen . . .”)
Blog
Post Reference:
LACTATED
RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
