CDC, NIPINFO@cdc.gov
Due to potential liability, I would encourage physicians to petition the FDA to
mandate that contraindication warnings be clearly listed in the package insert
for all drug/biologic products based on the "source of all
excipients;" since it is their responsibility to verify the source of
excipients prior to prescribing drug/biologic products to their patients with
confirmed IgE-mediated allergies.
Therefore,
I have forwarded the following documentation to the majority of pharmaceutical
companies, physician associations, and leading healthcare organizations in an effort to protect physicians from potential liability, in addition to protecting their patients from allergic
reactions to drug/biologic products. I will also be forwarding this
documentation to the leading medical journals.
Physicians
may be liable if they prescribe drugs/biologics containing excipients derived
from a patient's allergens, even if no contraindication warning is present in
the package insert. They are required to confirm the source of all excipients.
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-2-2020-email-to-world-allergy.html
My June 16,
2020, Email to the FDA Re: Corn Labeling in Drug/Biologic Products
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.
Physicians
continue to ignore the contraindication warning on the package insert
accompanying IV fluids to which dextrose (corn sugar derived from cornstarch)
has been added, even though it took me three years to forward the package
insert to our nation's hospitals, colleges of medicine, and colleges of
pharmacy. In addition, we continue to
receive reports from the 12K+ members in our corn allergy support groups that
physicians continue to prescribe drug/biologic products to their corn-allergic
patients, even though these products contain excipients derived from corn. Therefore, I have added a sixth option for
reporting these events.
"6. Consult with
legal counsel, since medical professionals are required to verify the
"source" of ALL excipients in drug/biologic products BEFORE
prescribing to their patients, even if no contraindication warning is present
on the drug label."
Revised June
24, 2020
LACTATED
RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
Added
References:
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.”
"Inactive"
ingredients in oral medications
93 percent of
medications contain 'potential allergens'
Thank
you for your attention to this growing concern, and it is my hope that
physicians file an immediate petition with the FDA to mandate these critical
contraindication warnings based on the source of excipients.
Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
Revised June
23, 2020
Pharmaceutical
Companies Contacted Re: Protocol for Treating Corn-Allergic Patients
https://cornallergyadvocacyresources.blogspot.com/2017/05/pharmaceutical-companies-contacted.html
Corn Allergy References, Surveys, Studies, Statistics, & Petitions
Additional
References:
PETITION:
DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC
PATIENTS
https://www.change.org/p/u-s-department-of-health-and-human-services-medical-biologic-products-with-dextrose-must-be-contraindicated-for-corn-allergic-patientsCorn Allergy References, Surveys, Studies, Statistics, & Petitions
(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
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