Monday, January 13, 2020

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

          Dextrose is the sugar derived from corn. [1] Therefore, Lactated Ringer’s with 5% Dextrose Solution is contraindicated for corn-allergic patients [2,3].  Since Vitamin K1 injection solution contains dextrose, why is it not contraindicated for corn-allergic patients, particularly since reported deaths have resulted from the administration of Vitamin K1 injection solution? Therefore, it is probable that some of these deaths were the result of an anaphylactic reaction to dextrose (the sugar derived from corn).

            In corn allergy support groups of nearly 12K members, many of these members are parents of corn-allergic infants/children, many of whom are anaphylactic to corn and corn-derived ingredients [4]Therefore, it is imperative that Vitamin K1 injection solutions, and all other injectable solutions with dextrose, contain a contraindication warning for administration to corn-allergic patients. In addition, it appears that this solution may contain other ingredients derived from corn or formulated using a corn medium; e.g., corn oil. [5]

            “Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose (emphasis added), hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0).

            BOXED WARNING
WARNING — INTRAVENOUS AND INTRAMUSCULAR USE

Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. (emphasis added).  Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.” [6]

Corn is considered a “major allergen” in many published corn allergy studies.[7]


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

References:

[1] DEXTROSE (CORN SUGAR): FDA FEDERAL REGULATION, GRAS - 184.1857
[2] LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
[3] PROBABLE ANAPHYLACTIC REACTION TO CORN-DERIVED DEXTROSE SOLUTION
[4] “Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17
[5] Oral Challenge of Mazola Corn Oil to Test Hypothesis Presented by Dr. Phil Lieberman
[Thankfully, the AAAAI removed this opinion paper from their website.]
[6] VITAMIN K1- phytonadione injection, emulsion
[7] Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)



Saturday, January 4, 2020

Corn Allergy: A Potentially Life-Threatening Diagnosis


Food Journals are Ineffective in Determining an Allergy to Corn

MY PERSONAL STORY

            July, 2008 through March, 2011:  It felt like everything I consumed was poisoning me.  Since I never had allergies, I thought it was GI-related, so I consulted with a gastroenterologist. After exhausting a myriad of tests (two of which put me in the hospital) and having my gallbladder removed, my gastroenterologist referred me to an allergist. During this time period, I kept a detailed food journal; and the only food product that appeared to cause a reaction was soy (mandatory labeling).

            My Daily Symptoms:  Pounding heart with premature ventricular contractions (PVCs), skyrocketing pulse rate, acute abdominal pain and distention, brain fog, depression, anxiety, sense of impending doom, and an overall feeling of utter misery.  Since I didn’t realize these were allergic reactions, I didn’t take an antihistamine. 

            March, 2011:  My allergist tested me using the skin-prick method,  and I was diagnosed with adult sudden-onset allergies to soy, all yeast, mushrooms, dairy, pork, salmon, scallops, pecans, dust mites, dogs, and cats. [Note that my allergist did not include corn in his standard panel of testing.]

            March, 2011 through December, 2011:  Even though I eliminated these triggers, I had no relief from my daily reactions.  During this time period, I conducted a drastic food elimination diet; e.g., I only consumed filtered water and ate a baked hamburger patty with Morton’s iodized salt (severe reaction).  On the last day of my food elimination diet, I only drank filtered water and ate a baked hamburger patty without salt.  This was the first time in 3 ½ years that I had no allergic reaction.  So I realized it was the salt!  But could I really be allergic to salt?  Morton’s Salt Company explained to me that iodized salt contains corn-derived dextrose. 

            December, 2011:  I requested that my allergist test me for a suspected allergy to corn, which was positive.  So I thought my reactions would finally cease if I deleted corn from my diet:  corn kernels and iodized salt.  Wrong!!

            [December, 2017:  I was also diagnosed with a life-threatening allergy to petroleum/petrolatum and to clavulanic acid (found in most antibiotics).]


Corn and Corn-Derived Ingredients are Ubiquitous and EXEMPT from FDA Labeling Requirements: 

            Although my allergy to corn was now confirmed, I continued to suffer severe allergic reactions to nearly everything I consumed.  My allergist and primary care physician admitted they knew nothing about navigating an allergy to corn, so I realized that I would have to conduct my own research.  This is when the stark realization hit me that my allergen is not only ubiquitous, but is EXEMPT from FDA labeling requirements.
 
            After drinking Mott’s and Ocean Spray 100%-advertised “pure” fruit juices, my reactions were swift and severe.  Both companies confirmed that these “pure” fruit juices contained corn-derived ascorbic acid. Who would have thought that corn is in fruit juice?

            I suffered another severe reaction after consuming Quaker 100% Oats (not allergic to oats).  This is when I learned about the dangers of cross-contact with corn, and Quaker issued a statement that anyone with an allergy to corn should avoid consuming their products due to the high probability of corn cross-contact through the many stages of shipping, processing, packaging, and handling.

            After suffering an allergic reaction to OTC vitamins, I soon discovered that most prescription drugs and vitamins contain corn (used as a common filler).[1]    

            I also continued to suffer allergic reactions to fresh meat, poultry, seafood, fruit, and produce.  This is when I discovered that these products are treated with FDA-mandated corn-derived acid washes.  So now I realized that I would have to purchase organic-only fresh food products. However, I was still reacting to some organic foods.  Again, I discovered that corn cross-contact remained an issue even with organic foods. In an effort to keep myself safe, all organic fresh food products are soaked and washed in a bath of cold filtered water (some tap water contains corn due to corn-derived purification chemicals),[2] Bragg’s apple cider vinegar (white vinegar in the United States is derived primarily from corn),[3] and baking soda.

            Due to my allergy to corn, it soon became apparent that before consuming any commercially-manufactured food product, I would have to contact manufacturers directly to inquire if a product contains corn-derived ingredients.  Typical replies from manufacturers include:

            1. “Corn is exempt from FDA labeling requirements.”  I then agreed with their statement indicating this was the reason for my inquiry due to my allergy to corn.
            2. “Our formulations are “proprietary;” therefore, we cannot disclose this information.”

            For the safety of corn-allergic consumers, it should be mandated that manufacturers must disclose, upon request, if their products contain corn-derived ingredients.


American Academy of Allergy Asthma & Immunology (AAAAI) and American College of Allergy, Asthma, & Immunology (ACAAI):

            Since I was now responsible for conducting my own research to guide me in navigating my allergy to corn, I referenced the AAAAI “Ask the Expert” and the ACAAI “Ask the Allergist” articles.  Based on the articles referenced on these websites, it was clear that many medical professionals also rely on their expert opinions.  Unfortunately, I soon realized that many medical professionals relied on these “expert” opinions without questioning the validity of their claims.

            After I read the following declaration by Phil Lieberman, MD, related to consuming corn oil, I conducted an oral challenge of Mazola corn oil, and suffered a severe allergic reaction.[4,7]  Thankfully, the AAAAI immediately removed this article at my request, and I personally contacted Dr. Lieberman with the results of my oral challenge to corn oil.

            ". . . the issue is complex because some products, such as corn oils, are labeled as having corn, but actually do not contain corn allergen."
“Avoidance of Corn Allergen," AAAAI, Ask the Expert, 2012

            After I read the following declaration on the ACAAI’s website regarding cornstarch and corn syrup, I conducted an oral challenge of Argo cornstarch, and suffered a severe allergic reaction.[5,6,7,8]  A year after mailing the ACAAI a certified letter, they finally redacted their claim regarding cornstarch; however, we continue to appeal to them to redact their equally-false statement regarding corn syrup. 

             “Most corn-derived products, like cornstarch and high-fructose corn syrup, do not contain corn protein. If you have a corn allergy, you do not need to avoid these products.”


Hospital Care with an Allergy to Corn:

            Since the only guaranteed corn-free product on hospital premises is straight saline-only IV fluid, I realized that I would be required to supply my own previously-prepared corn-free foods, fluids, and medications while hospitalized.  What would happen if my hospital admission were due to an emergency?

            Due to numerous reports in our corn allergy support groups of nearly 12K members [9] that hospital personnel continue to prescribe medications containing corn-derived ingredients, and continue to administer dextrose IV fluids in direct violation of the contraindication warning on the package insert,[10,11] it took me three years to forward this critical corn allergy documentation to the majority of our nation’s hospitals, colleges of medicine, and colleges of pharmacy.[12,13,14,15]  However, we continue to receive reports that medical personnel remain oblivious to the dangers of navigating an allergy to corn.      

            Therefore, an allergy to corn should be considered a potentially life-threatening diagnosis; since hospitals remain ill-equipped to treat/nourish corn-allergic patients, and since corn is considered a “major allergen” in many published corn allergy studies.[16]  In addition, it remains a daily struggle for survival for corn-allergic consumers in their efforts to source corn-free foods, fluids, and medications due to the fact that corn is EXEMPT from FDA labeling requirements.


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


References:    

[1] BCPharmacists, "Warning: corn-related allergens . . ."
[2] "A mother's desperate struggle to find safe water for her corn-allergic infant son."
[3] "Vinegar is an aqueous solution of acetic acid and trace chemicals that may include flavorings. .... Apple cider vinegar is made from cider or apple must, and has a ... or sukang basi), although it also is produced in France and the United States. .... regions, because of its low cost, is barley malt, or in the United States, corn."
[4] Oral Challenge of Mazola Corn Oil to Test Hypothesis Presented by Dr. Phil Lieberman
[Conclusion:  If you allergic/intolerant to corn, do not consume corn oil.  I suffered a significant allergic reaction as a result of this oral challenge.]
[5] Argo Cornstarch Oral Challenge to Test Hypothesis Presented by the ACAAI
 [Conclusion: If you are allergic to corn, do not consume cornstarch. I suffered a significant allergic reaction as a result of this oral challenge.]
[6] My March 27, 2018, Certified Letter to the ACAAI  Re: Cornstarch and Corn Syrup
[7] Removing a Food Protein Does Not Guarantee an Allergen Hypoallergenic
[8] Petition to Demand that the ACAAI Remove False Statement Re: Cornstarch/High Fructose Corn Syrup
[9] December, 2019, Month-End Corn Allergy Statistics: 878.9% Increase in 78 Months
[10] LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
[11] DEXTROSE (CORN SUGAR): FDA FEDERAL REGULATION, GRAS - 184.1857
[12] United States Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic Patients
[13] Colleges of Medicine Contacted Re: Protocol for Treating Corn-Allergic Patients
[14] Colleges of Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients
[15] “Corn Products and Derivatives List,” Institute for Responsible Technology (IRT), 6/6/17
[16] Published Corn Allergy Studies/Statistics  (“. . . Maize major allergen . . .”)


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 nearly 12K 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 on the package insert, even though I spent three years forwarding this documentation to our nation’s hospitals, colleges of medicine, and colleges of pharmacy. 

            If dextrose 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.      File a MedWatch Voluntary Report with the FDA.

4.      Obtain the name of the person who administered the dextrose IV fluid, and file a complaint with their state licensing board.

5.      File a Patient Safety Event Report with the administrator of the medical facility where the incident occurred. 


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

               
REFERENCES FOR LACTATED RINGER’S IN 5% DEXTROSE IV FLUID:         

LACTATED RINGERS IN 5% DEXTROSE
Generic Name: lactated ringer's and 5% dextrose injection
Brand Name: Lactated Ringer's in 5% Dextrose

CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.” (emphasis added)


Lactated Ringer’s and 5% Dextrose Injection, USP
in VIAFLEX Plastic Container

Dextrose is derived from corn.” (emphasis added)


LABEL: DEXTROSE IN LACTATED RINGERS- dextrose, sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution

CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.” (emphasis added)


DEXTROSE IN LACTATED RINGERS- dextrose, sodium chloride, sodium lactate, potassium
chloride, and calcium chloride injection, solution
B. Braun Medical Inc.
----------
5% Dextrose in Lactated Ringer's Injection

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.” (emphasis added)


Baxter Lactated Ringer’s and 5% Dextrose Injection, USP

WARNINGS
Solutions containing dextrose should be used with caution, if at all, in patients with known allergy to corn or corn products.”(emphasis added)


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.


ADDITIONAL REFERENCES:

Chapter 35 Error Reporting and Disclosure

DEXTROSE (CORN SUGAR): FDA FEDERAL REGULATION, GRAS - 184.1857

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.”

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

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

Corn Allergy: A Potentially Life-Threatening Diagnosis

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

United States Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic Patients

Colleges of Medicine Contacted Re: Protocol for Treating Corn-Allergic Patients

Colleges of Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients

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.)
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html








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/corn-derived ingredients are exempt from FDA labeling requirements 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