Sunday, March 7, 2021

My March 7, 2021, Appeal to AstraZenecaUS to include contraindication warnings for drug/biologic products based on "source of excipients"

Among my numerous IgE-mediated allergies, my primary concern is due to my IgE-mediated allergies to corn, yeast, soy, petroleum (confirmed via patch test), pork, and blue dye; since these excipients (or derivatives thereof) are often included in drug/biologic products without any contraindication warning.  I am also hypersensitive to preservatives (acute tachycardia). 

What is even more troubling to me is the lack of knowledge by the majority of clinicians and pharmacists about the dangers of non-medicinal ingredients (NMIs) contained in drug/biologic products. I doubt that very few clinicians are aware that ethyl acetate is a “yeast-derived” excipient, which can prove fatal to me (anaphylactic to all yeast).  The only way I discovered this fact was after I suffered an anaphylactic reaction to Folger’s decaf coffee.  Folger’s explained that their coffee beans are processed using ethyl acetate (a yeast medium). I also doubt that very few clinicians are aware of all of the chemical names identifying petroleum-based excipients, or the nearly 200 names identifying the most common corn-derived excipients in drug/biologic products. I was unable to locate any list identifying yeast-derived excipients; e.g., ethyl acetate.

The lack of contraindication warnings is of particular concern for corn-allergic patients, since the majority of drug/biologic products contain corn-derived excipients.  As a result, many of the 13.5+ members in our corn allergy support groups must have their drugs compounded to exclude corn.  Their personal testimonies confirm that the majority of clinicians remain oblivious to "undefined" corn in drug/biologic products.  This critical lack of knowledge by clinicians is also confirmed in my April 20, 2020, email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines.

My April 20, 2020, Email to the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines
https://cornallergyadvocacyresources.blogspot.com/2020/05/my-april-20-2020-email-to-childrens.html


My post in our corn allergy support group:

For those of you who are using podcasts to raise corn allergy awareness, this is a topic I would encourage you to address. I know we are all sick and tired of the endless commercials by Big Pharma; however, do you notice at the end of each commercial they warn against taking the drug if you are allergic to any of the ingredients?

How are patients supposed to know if they may be allergic to any of the ingredients if the "sources" of those ingredients are not listed, or contraindication warnings indicated based on the "source" of the excipients?

Since corn is exempt from FDA labeling requirements, allergic reactions to corn-derived excipients are currently categorized as idiopathic. This practice further suppresses corn allergy awareness/statistics.

I have written numerous blog posts addressing this critical issue; however, our message has fallen on deaf ears. We need to stress the reality and importance of this particular issue.

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

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"
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-5-2020-email-to-fda-re.html

My June 8, 2020, Appeal to My State Congressional Representatives Requesting Contraindication Warnings for Drug/Biologic Products Based on the “Source of Excipients”
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-8-2020-appeal-to-my-state.html

My June 24, 2020, Email to the FDA and CDC Addressing Contraindication Warnings for Drug/Biologic Products Based on the Source of Excipients
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-24-2020-email-to-fda-and-cdc.html

 

My appeals to the FDA, my state congressional representatives, and the World Health Organization requesting contraindication warnings on drug/biologic products based on the “source of excipients” have gone unheeded.  These contraindication warnings are critical for the protection of patients with IgE-mediated allergies, in addition to protecting clinicians from potential liability.  Before prescribing drug/biologic products to patients, physicians are required to confirm the source of all excipients, or risk potential liability if they prescribe a drug/biologic product to a patient containing their allergen, or any derivative thereof.

Since my appeals have gone unheeded, I decided to contact one pharmaceutical company (AstraZeneca) directly with my concerns.  For the safety of all patients with IgE-mediated allergies, it is my hope that they will consider my appeal for contraindication warnings based on the “source of excipients” in drug/biologic products.   

AstraZeneca Medications

@AstraZenecaUS Brilinta can prove FATAL to corn-allergic patients due to corn-derived excipients. How are clinicians/patients expected to know this drug
contains corn without a contraindication warning?
https://www.rxlist.com/brilinta-drug.htm#description

@AstraZenecaUS Bydureon Bcise should contain contraindication warnings based on the source of excipients so clinicians can make informed decisions on behalf of their patients.
https://www.rxlist.com/bydureon-bcise-drug.htm#description

@AstraZenecaUS Calquence can prove FATAL to corn-allergic patients due to corn-derived excipients. How are clinicians/patients expected to know this drug contains corn without a contraindication warning?
https://www.rxlist.com/calquence-drug.htm#description

@AstraZenecaUS Crestor can prove FATAL to corn-allergic patients due to corn-derived excipients. How are clinicians/patients expected to know this drug contains corn without a contraindication warning?
https://www.rxlist.com/crestor-drug.htm#description

@AstraZenecaUS Daliresp can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this drug contains corn without a contraindication warning?
https://www.rxlist.com/daliresp-drug.htm#description

@AstraZenecaUS Enhertu can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this drug contains corn without a contraindication warning?
https://www.rxlist.com/enhertu-drug.htm#description

@AstraZenecaUS Epanova can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/epanova-drug.htm

@AstraZenecaUS Farxiga can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/farxiga-drug.htm#description

@AstraZenecaUS Fasenra can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/fasenra-drug.htm#description

@AstraZenecaUS Faslodex can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/faslodex-drug.htm

@AstraZenecaUS FluMist can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/flumist-drug.htm#overdosage

@AstraZenecaUS FluMist can prove FATAL to patients with an allergy to pork. How are clinicians/patients expected to know this product contains pork without a contraindication warning?
https://www.rxlist.com/flumist-drug.htm#overdosage

@AstraZenecaUS Imfinzi can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/imfinzi-drug.htm

@AstraZenecaUS Iressa can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/iressa-drug.htm#description

@AstraZenecaUS Kombiglyze XR can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/kombiglyze-xr-drug.htm

@AstraZenecaUS Kombiglyze XR can prove FATAL to anyone with an allergy to yeast. How are clinicians/patients expected to know this product contains yeast without a contraindication warning?
https://www.rxlist.com/kombiglyze-xr-drug.htm

@AstraZenecaUS Kombiglyze XR can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/kombiglyze-xr-drug.htm

@AstraZenecaUS Koselugo can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/koselugo-drug.htm

@AstraZenecaUS Lumoxiti can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/lumoxiti-drug.htm

@AstraZenecaUS Lynparza can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/lynparza-drug.htm

@AstraZenecaUS Nexium can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/nexium-drug.htm#description

@AstraZenecaUS Onglyza can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/onglyza-drug.htm#description

@AstraZenecaUS Onglyza can prove FATAL to anyone with an allergy to yeast. How are clinicians/patients expected to know this product contains yeast without a contraindication warning?
https://www.rxlist.com/onglyza-drug.htm#description

@AstraZenecaUS Onglyza can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/onglyza-drug.htm#description

@AstraZenecaUS Pulmicort Respules can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/pulmicort-respules-drug.htm

@AstraZenecaUS Qtern can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/qtern-drug.htm

@AstraZenecaUS Qtern can prove FATAL to anyone with an allergy to yeast. How are clinicians/patients expected to know this product contains yeast without a contraindication warning?
https://www.rxlist.com/qtern-drug.htm

@AstraZenecaUS Qtern can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/qtern-drug.htm

@AstraZenecaUS Qternmet XR can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/qternmet-xr-drug.htm

@AstraZenecaUS Qternmet XR can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/qternmet-xr-drug.htm

@AstraZenecaUS Seroquel can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/seroquel-drug.htm#description

@AstraZenecaUS Seroquel can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/seroquel-drug.htm#description

@AstraZenecaUS Seroquel XR can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/seroquel-xr-drug.htm

@AstraZenecaUS Seroquel XR can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/seroquel-xr-drug.htm

@AstraZenecaUS Symbicort can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/symbicort-drug.htm#description

@AstraZenecaUS Symlin can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/symlin-drug.htm#description

@AstraZenecaUS Symlin can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/symlin-drug.htm#description

@AstraZenecaUS Tagrisso can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/tagrisso-drug.htm#description

@AstraZenecaUS Tagrisso can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/tagrisso-drug.htm#description

@AstraZenecaUS Xigduo XR can prove FATAL to corn-allergic patients due corn-derived excipients. How are clinicians/patients expected to know this product contains corn without a contraindication warning?
https://www.rxlist.com/xigduo-xr-drug.htm

@AstraZenecaUS Xigduo XR can prove FATAL to anyone with an allergy to petroleum. How are clinicians/patients expected to know this product contains petroleum without a contraindication warning?
https://www.rxlist.com/xigduo-xr-drug.htm

@AstraZenecaUS It is very difficult to avoid petroleum if you have an IgE-mediated allergy to petroleum.  If drug/biologic products contain any petroleum-derived excipients, it is critical that contraindication warnings are listed in the pkg insert.  https://context.capp.ca/articles/2019/feature_petroleum-in-real-life_pills

@AstraZenecaUS The majority of medical professionals are oblivious to this list of the most common corn-derived excipients, which can prove fatal to corn-allergic patients.

"Corn Allergy Food List"
https://www.leavesoflife.com/corn-allergy-food-list/?fbclid=IwAR1v_17JjwBItTzKGX9NcGwSpiwC_3Hgggq6mYQawQOlrdQWfn8vm18nB_4

 

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

References:

Administering dextrose-containing drug/biologic products to corn-allergic patients is a critical medical error equivalent to administering penicillin to patients with an allergy to penicillin. 
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

"It turns out Sherri was getting a steady stream of corn from twelve different medications she was prescribed." [emphasis added]
https://www.krem.com/article/news/local/2-on-your-side/deer-park-woman-sickened-due-to-medications-inactive-ingredients/293-616349681

93 percent of medications contain 'potential allergens'
https://www.medicalnewstoday.com/articles/324681

"Inactive" ingredients in oral medications
https://stm.sciencemag.org/content/11/483/eaau6753

Non-medicinal ingredients don’t appear on drug labels
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM
https://cornallergyadvocacyresources.blogspot.com/2020/06/pharmacists-confirm-study-of-nmis-non.html

My Doctor Prescribed the Wrong Medication. Is It Medical Malpractice? By Prathyusha Chowdri
"The doctor prescribes a medication which contains an ingredient to which the patient is allergic." [emphasis added]
https://www.nolo.com/legal-encyclopedia/my-doctor-prescribed-the-wrong-medication-is-malpractice.html

Petroleum in Real Life: Pills:
Did you know aspirin and medications using time-release capsules are made possible using oil and natural gas-based petrochemicals?
https://context.capp.ca/articles/2019/feature_petroleum-in-real-life_pills

List of most common corn-derived excipients [not all-inclusive]
https://www.leavesoflife.com/corn-allergy-food-list/?fbclid=IwAR1v_17JjwBItTzKGX9NcGwSpiwC_3Hgggq6mYQawQOlrdQWfn8vm18nB_4

 

Source:

AstraZeneca Medications
https://www.astrazeneca-us.com/medicines/astrazeneca-medications.html

 

Blog Post Reference:

My March 7, 2021, Appeal to AstraZenecaUS to include contraindication warnings for drug/biologic products based on "source of excipients"
https://cornallergyadvocacyresources.blogspot.com/2021/03/my-march-7-2021-appeal-to-astrazenecaus.html

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