Re: Prescribing Drug/Biologic Products to Patients with
IgE-Mediated Allergies to Excipients
In our corn allergy support
groups of over 12K members, we continue to receive reports of medical
professionals 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 package
insert and other corn allergy documents to our nation’s hospitals, colleges of
medicine, and colleges of pharmacy. In addition, we continue to receive reports
that medical professionals routinely prescribe drugs to corn-allergic patients
that contain corn-derived excipients
even though the patient’s allergy to corn is documented in their medical
records.
The fact that corn has not
been declared an official allergen is not an excuse for any medical
professional to prescribe or administer drug or biologic products containing
corn-derived excipients to corn-allergic patients. Since pharmacists are not trained in their
colleges of pharmacy to recognize the dangers of NMIs (non-medicinal
ingredients) in drugs, we must be able to trust that medical professionals are
capable of protecting us from our allergens when prescribing drug/biologic
products.
1.
I contacted the
CDC and requested that they provide me with a list of their vaccines that
contain corn-derived excipients, which would therefore be contraindicated for
corn-allergic patients. The CDC directed
me to the FDA.
2.
The FDA couldn’t answer my question, and
advised me to contact the drug and biologic manufacturers directly.
3.
I contacted Merck
and GSK. They told me they could not
release this information to me, and stated they could only release the information to my allergist. I explained to them that after my allergist
diagnosed me with an IgE-mediated allergy to corn in 2011, he stated that he was
not familiar with the complexities associated with corn allergies; so I
conducted my own research in an effort to safely navigate this devastating
allergy. They refused to release this information to me.
I also recently discovered that it is not the pharmacist’s responsibility to inform corn-allergic patients if a drug or biologic product contains corn-derived excipients, since they were not trained about the possible dangers of NMIs (non-medicinal ingredients) in drugs, or even how to identify excipients derived from corn.
Therefore, apparently the
responsibility lies with our medical professionals to know which drugs and
biologics contain corn-derived excipients.
Of course, since the word “corn” is rarely identified on drug labels
containing corn-derived excipients, our physicians would need to contact each
drug/biologic manufacturer each time a drug is prescribed – particularly since
their formulations may change over time.
Thank you for your attention to this critical concern.
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Twitter: @CornAllergy911
References:
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
LACTATED RINGER’S IN 5%
DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
My April 20, 2020, Email to
the Children’s Hospital of Philadelphia Re: Corn Allergies and Vaccines
[Since the FDA did not reply
to my email, I called them, which is when they referred me directly to the
vaccine manufacturers.]
My May 11, 2020, Email to the
FDA Re: Corn-Derived Excipients in Vaccines
DEXTROSE (CORN SUGAR), CODE
OF FEDERAL REGULATION 21CFR184.1857
PETITION: DRUG PRODUCTS
W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
My March 5, 2020, Email to
the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857,
vs. Glucose (Blood Sugar)
Corn Allergy: A Potentially
Life-Threatening Diagnosis
BCPharmacists, "Warning:
corn-related allergens . . ."
"Probable anaphylactic
reaction to corn-derived dextrose solution."
Published Corn Allergy
Studies/Statistics (“. . . Maize major
allergen . . .”)
Corn is ubiquitous and is EXEMPT from FDA labeling
requirements; therefore, allergic reactions are currently categorized as
idiopathic, resulting in underreporting and suppression of corn allergy
statistics.
May, 2020, Month-End Corn
Allergy Statistics: 935.2% Increase in 83 Months
FDA CONFIRMS THAT CORN IS
EXEMPT FROM FDA LABELING REQUIREMENTS
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-confirms-that-corn-is-exempt-from.html
United States
Hospitals/Health Systems Contacted Re: Protocol for Treating Corn-Allergic
Patients
https://cornallergyadvocacyresources.blogspot.com/2017/07/united-states-hospitalshealth-systems.html
Colleges of Medicine
Contacted Re: Protocol for Treating Corn-Allergic Patients
Colleges of Pharmacy
Contacted Re: Protocol for Treating Corn-Allergic Patients
Pharmaceutical Companies
Contacted Re: Protocol for Treating Corn-Allergic Patients
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