Tuesday, June 9, 2020

My June 8, 2020, Appeal to My State Congressional Representatives Requesting Contraindication Warnings for Drug/Biologic Products Based on the “Source of Excipients”


 MY APPEAL TO MEMBERS OF THE CORN ALLERGY COMMUNITY

Please contact your state congressional representatives to demand that they pass an emergency mandate requiring that drug/biologic manufacturers list contraindication warnings for these products based on the “source of the excipients.”

Thank you very much for your contribution to this effort.

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

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My June 8, 2020, Appeal to My State Congressional Representatives Requesting Contraindication Warnings for Drug/Biologic Products Based on the “Source of Excipients”

“What allergen restricts access to basic human requirements: fresh foods, water, drugs, and clothing? CORN!"

This is the title of the next article I am writing, which will include studies, statistics, and devastating personal testimonies confirming the daily struggle for survival with an allergy to corn [not recognized as an official allergen].

However, I want to address the lack of available drugs for corn-allergic patients immediately; since corn-derived excipients are not only used as common fillers in the majority of prescription/OTC drug/biologic products, but these drugs contain NO CONTRAINDICATION WARNING FOR ADMINISTRATION TO CORN-ALLERGIC PATIENTS BASED ON THE SOURCE OF THESE EXCIPIENTS. 

In our corn allergy support groups of over 12K members [note that this is more than double the members of sesame seed allergy support groups], we read testimonies daily of physicians prescribing drugs to their corn-allergic patients which contain inactive ingredients derived from corn; thereby, resulting in unnecessary allergic reactions (including anaphylaxis) to their patients.  This is due to the fact that drugs containing corn-derived excipients do not currently contain a contraindication warning for administration to corn-allergic patients based on the source of the excipients.* Since physicians and pharmacists are not educated to understand the dangers of NMIs (non-medicinal ingredients) in drug/biologic products; and particularly since these drug/biologic products lack the critical contraindication warnings, these unfortunate incidents occur nearly every day.

Reprinted with permission (pharmacist who is member of a corn allergy support group):

"I’m a pharmacist who works in community practice. Earned my doctorate in 2007. We don’t learn hardly anything about the sources of inactive ingredients in school. I would never have known that so many meds have corn and corn derivatives in them unless my son had been diagnosed with FPIES in 2015. I would venture to say only a handful of other pharmacists nationwide are aware of this particular issue." - Pharmacist

I have just forwarded an appeal to the FDA to pass an emergency mandate requiring that drug/biologic product manufacturers be required to list contraindication warnings based on the 'SOURCE OF EXCIPIENTS' in these products for the safety of all patients diagnosed with allergies.     

I also forwarded this appeal to the majority of pharmaceutical companies with a hope that they will immediately adopt this practice prior to a mandate being issued. 

We would appreciate your assistance on behalf of all citizens suffering with allergies.

Sincerely,
Diane H., Corn Allergy Advocate

*There are only a handful of drugs containing this warning; e.g., IV drugs w/dextrose (corn sugar derived from cornstarch per Code of Federal Regulation 21CFR184.1857), and even these contraindication warnings are inconsistent.  Due to the fact that most physicians continue to miss this critical contraindication warning on IV fluids w/dextrose, it took me three years to forward the package insert to our nation's hospitals, colleges of medicine, and colleges of pharmacy."

References:

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"

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS

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

Pharmaceutical Companies Contacted Re: Protocol for Treating Corn-Allergic Patients

Corn Allergy for Newbies

Corn Allergy: A Potentially Life-Threatening Diagnosis

FDA AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE

A mother's desperate struggle to find safe water for her corn-allergic infant son.

May, 2020, Month-End Corn Allergy Statistics: 935.2% Increase in 83 Months
(Corn is ubiquitous and corn allergen warnings are voluntary.)


Source:

Senators of the 116th Congress
https://www.senate.gov/general/contact_information/senators_cfm.cfm

United States House of Representatives 116th Congress


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