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.
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.
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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