Monday, December 30, 2019

December, 2019, Month-End Corn Allergy Statistics


In one corn allergy group of 9,789 members (170* of whom are anaphylactic to corn), there has been an 878.9% increase in corn allergies in the last 78 months, with an average of 112.7 new members/month.

*Poll taken in May, 2017:  Members prescribed epinephrine auto-injector pens as a result of their allergy to corn.


Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)



Corn Allergy Symptoms:
American College of Allergy, Asthma & Immunology

WebMD

Healthline

"The Surprising Food That May Cause Anger & Aggression," Jaclyn Harwell
http://deeprootsathome.com/the-surprising-food-that-may-cause-anger-aggression/



Corn products/derivatives to avoid if you are allergic to corn

“Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17

"Corn Allergy and Following a Corn-Free Diet," by Daniel More, MD, a board-certified physician, June 15, 2018, verywellhealth

"Ingredients Derived From Corn - What to Avoid," By Sharon Rosen, Live Corn Free

"Corn-Free Diet," Golisano Children's Hospital, Pediatric Nutrition

"Hidden Corn Based Ingredients," Gluten Free Society

"Corn Allergy," Multiple Food Allergy Help

"Corn Derivatives List," Corn Allergy Mom

"Corn Allergy Food List"


Corn Allergy References
(Includes my submission to The Joint Commission, Congress, FDA, & U.S. Dept. of Health requesting emergency mandate that hospitals stock corn-free foods, liquids, & drugs.)


Data Collection Methods:



Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Email: cornallergyinitiative@gmail.com
Twitter: @CornAllergy911


Source:
“Corn Allergy,” Wikipedia
“External Links: Corn Allergy and Intolerance Online support group for corn allergy and intolerance.”



Sunday, December 22, 2019

Lactated Ringer's in 5% Dextrose Contraindicated for Corn-Allergic Patients


            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/
           
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
[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)
[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.”
[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
[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



Monday, December 2, 2019

SURVEY OF ADULTS DIAGNOSED WITH AN ALLERGY TO CORN

SURVEY CONDUCTED BY
 CORN ALLERGY ADVOCACY/RESOURCES
December 4, 2019

_______________________________________________________________

I would also like to extend my deepest gratitude to members of corn
allergy support groups for their contributions in the preparation of this survey.
_______________________________________________________________

This survey is to be completed by adults diagnosed with an allergy to corn.  Your responses will be kept strictly confidential.  
Please copy the survey to a Word® document, and submit your replies to cornallergyinitiative@gmail.com.
_______________________________________________________________

1.      Do you have a physician-diagnosed allergy to corn?


2.      In what year was your allergy to corn diagnosed?


3.      Did your allergist include corn allergy as part of a standard panel of testing?


4.      Did you have to request that your allergist test you for a suspected corn allergy?


5.      Did your allergist ever refuse to test you for a suspected allergy to corn?  If yes, what was the allergist’s reason for refusing the test?





6.      Did you ever seek a second opinion for a suspected corn allergy because your allergist refused to test for an allergy to corn? If so, was your allergy to corn confirmed after seeking a second opinion?



7.      Did your allergist prescribe an epinephrine auto-injector pen for you as a direct result of your anaphylactic reaction to corn/corn-derived ingredients?


8.      How many times in the last year was an epinephrine auto-injector pen required due to your anaphylactic reaction to corn?


9.      Did your allergist or any other medical professional advise you that even though you have a confirmed allergy to corn, it would be safe to continue consuming corn or corn derivatives?




10.  Has your allergist been helpful in recommending corn-free foods, fluids, supplements, or medications?





11.  Do you find it difficult to obtain adequate nutrition as a result of your allergy to corn? If yes, please explain; e.g., are you unable to take vitamins or nutritional supplements due to corn-derived ingredients in these products?



12.  Did your physician or hospital prescribe medications for you that contained corn-derived ingredients, even though your allergy to corn was clearly indicated in your medical records?  If yes, how was this issue resolved?






13.  Are you aware if your physician or hospital declared you as “non-compliant” for refusing physician-prescribed medications due to corn-derived ingredients in the prescribed medications, even though your allergy to corn was clearly indicated in your medical records?




14.  Do you require compounded medications to exclude corn?  If yes, does your insurance cover the cost of compounded medications?



15.  If you require compounded drugs to exclude corn-derived ingredients, was the pharmacy able to fill the prescription to exclude corn?  Were there any drugs prescribed by your physician that could not be compounded to exclude corn-derived ingredients?  Please explain.



16.  If you were hospitalized, was the hospital fully equipped to treat/nourish you?  If no, please explain.  .






17.  If you were hospitalized, did you ever have to advise the hospital against administering dextrose IV fluid, or was the staff already aware of the warning on the product information sheet accompanying dextrose IV fluids that it should not be administered to corn-allergic patients?




18.  Did any medical professional ever administer dextrose IV fluid to you, even though your allergy to corn was clearly indicated in your medical records?  If yes, did you suffer an allergic reaction to the dextrose IV fluid?  If yes, how was this situation resolved; e.g., did you file a report with The Joint Commission?








19.  Do you have ready-access to corn-free antihistamines?  If no, please explain.






20.  Do you have difficulty finding corn-free foods, fluids, and/or medications?  If yes, please explain.    





21.  Are you ingestion-reactive to corn?


22.  Are you contact-reactive to corn?


23.  Are you inhalation-reactive to corn?


24.  What are your symptoms after exposure to corn?





25.  Have you consulted with a nutritionist as a direct result of your corn allergy diagnosis?


26.  Was your nutritionist able to recommend safe sources of corn-free foods?


27.  Do you feel that your nutritionist was trained to address a corn allergy diagnosis?




28.  Has a food manufacturer ever refused to disclose if their product(s) contain corn/corn-derived ingredients upon your request?




29.  Has a food manufacturer ever told you that their products are safe to consume since the corn “protein" has been removed?  Did you then suffer an allergic reaction to this product as a result of your corn allergy?  If yes, how was this issue resolved; e.g., did you file an adverse reaction report with the manufacturer, the FDA, or the applicable health department?





30.  Does your allergy to corn restrict your social activities?  If yes, please explain.  






31.  Does your allergy to corn restrict your travel?  If yes, please explain. 





32.  Please explain how your allergy to corn has impacted your life (emotionally, financially, etc.).











33.  Does the fact that corn allergen warnings are voluntary on product labels hinder your ability to find corn-free foods, fluids, and/or medications?  If yes, please explain. 





34.  Due to corn-derived purification chemicals in some tap water, can you safely consume tap water in your home; or have you been required to purchase corn-free water from another source, or install a corn-free water filtration system in your home? 







35.  Has any medical or academic professional ever implied to you that “There is no such thing as an allergy to corn,” or that “Corn is hypoallergenic?”  As a result, did you feel that you were demeaned in any manner?  If yes, please explain.






36.  Please add any additional information about your allergy to corn that is not addressed in this survey.










_______________________________________________________________

Thank you for your participation is this survey.


Diane H., Corn Allergy Advocate
Founder, Corn Allergy Advocacy/Resources








CORN SUGAR (DEXTROSE), CODE OF FEDERAL REGULATION 21CFR184.1857

(Revised June 1, 2020)

            The Code of Federal Regulation 21CFR184.1857 defines dextrose as “corn sugar,” which is produced from the “complete hydrolysis of corn starch with safe and suitable acids or enzymes, followed by refinement and crystallization from the resulting hydrolysate.”

          It is for this reason that IV fluid with added dextrose (corn sugar derived from cornstarch) is clearly contraindicated for administration to corn-allergic patients in the package insert; however, some IV fluids with added dextrose are lacking this critical contraindication warning.


Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter:  @CornAllergy911

References:

BCPharmacists, "Warning: corn-related allergens . . ."

"Probable anaphylactic reaction to corn-derived dextrose solution."

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION WARNING]

ACD-A Anticoagulant Citrate Dextrose Solution, Solution A [NO CONTRAINDICATION WARNING]

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccine

My May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines

Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)

Grape Sugar: [alpha]-D-glucopyranose

The FDA and the NIH NLM believe that vine grapes are produced from (grown on) corn stalks!   Grape Sugar: [alpha]-D-glucopyranose Grape suga...