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"

(Updated June 8, 2020, to include Facebook message sent to my state congressional representatives.)

ADDENDUM ADDED FOR PATIENTS WITH IgE-MEDIATED ALLERGIES

Pharmacists are not educated in recognizing the dangers of NMIs (non-medicinal ingredients) in drugs. For example, if you inform your pharmacist that you are allergic to corn, the pharmacist only relies on the contraindication warnings provided by the drug/biologic product manufacturers. Therefore, the pharmacist has no idea that Atenolol, which clearly contains corn-derived excipients, would be contraindicated for corn-allergic patients; since the manufacturer has not declared that this drug is contraindicated for corn-allergic patients. Pharmacists also trust that the prescribing physician is prescribing drugs that are safe for a particular patient, since physicians maintain the patient's medical records with a list of their allergens. Thus, the primary responsibility rests with the patient's physician to guarantee that the drugs they prescribe do not contain their patient's allergen, or derivative thereof.

------------------------------------------------------------

To:      KC, Pharmacist

           Division of Drug Information

           Center for Drug Evaluation and Research

           druginfo@fda.hhs.gov

Re:      Emergency Mandate Requiring Contraindication Warnings be
Listed for Drug/Biologic Products Based on the "Source of Excipients"

Due to my concern that physicians routinely prescribe drugs containing a patient's allergen (or derivative thereof), particularly when their allergen is clearly documented in their medical records; I sent the following email to the World Allergy Organization addressing this issue.  After conducting my own research, apparently the responsibility rests solely with the prescribing physician to guarantee that the prescribed medication does not contain the patient's allergen, or derivative thereof.  Therefore, it is the physician's responsibility to know the source of all inactive ingredients derived from corn (or any other source) commonly found in drug/biologic products prior to prescribing drugs.  It doesn't matter that a particular drug lacks a contraindication warning based on the source of these excipients; e.g., Atenolol from one pharmaceutical company should contain a contraindication warning for administration to corn-allergic patients due to corn-derived excipients.  It is the physician's responsibility to contact each drug manufacturer to confirm the source of excipients for the safety of the physician's patients; and the fact that corn has not been declared an official allergen does not exempt the physician from potential liability for prescribing a drug containing corn-derived excipients to his/her corn-allergic patient.  Lack of knowledge is not an excuse; e.g., a physician cannot claim that he/she prescribed a drug or vaccine containing corn-derived excipients based on the egregious false definition of dextrose posted on the Drugs.com website, or the equally-egregious claim posted on the Children's Hospital of Philadelphia's website, "Corn Allergies and Vaccines."  I have forwarded my rebuttals/documentation to Drugs.com in addition to the Children's Hospital of Philadelphia.  I have also provided documentation to Dr. Paul Offit, contributor to this article, in an effort to protect the lives of corn-allergic patients.   

Thank you for your attention to this critical concern.

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

References:

My June 2, 2020, Email to the World Allergy Organization (WAO)
https://cornallergyadvocacyresources.blogspot.com/2020/06/my-june-2-2020-email-to-world-allergy.html

ATENOLOL AND CHLORTHALIDONE tablet
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6794dfa-adbb-491b-9d48-f89a44e866c5

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 May 11, 2020, Email to the FDA Re: Corn-Derived Excipients in Vaccines
https://cornallergyadvocacyresources.blogspot.com/2020/05/my-may-11-2020-email-to-fda-re-corn.html

My March 5, 2020, Email to the FDA Re: Dextrose (Corn Sugar), Code of Federal Regulation 21CFR184.1857, vs. Glucose (Blood Sugar)
https://cornallergyadvocacyresources.blogspot.com/2020/03/email-to-fda-re-dextrose-corn-sugar-per.html

PETITION: DRUG PRODUCTS W/DEXTROSE MUST BE UNIFORMLY CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2020/04/petition-medicalbiologic-products-with.html

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

Vitamin K1 Injection Contains Corn-Derived Dextrose [NO CONTRAINDICATION WARNING]
https://cornallergyadvocacyresources.blogspot.com/2020/01/vitamin-k1-injection-contains-corn.html

LACTATED RINGER’S IN 5% DEXTROSE CONTRAINDICATED FOR CORN-ALLERGIC PATIENTS
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

BCPharmacists, "Warning: corn-related allergens . . ."

http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

[It is the physician's responsibility to identify corn-derived excipients in drug/biologic products prior to prescribing for corn-allergic patients.  This also applies to the source of other excipients not derived from corn for the safety of all patients with a variety of IgE-mediated allergies.]

Corn products/derivatives to avoid if you are allergic to corn
https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html

UPDATE:

June 8, 2020

Facebook message sent to my state congressional representatives with my urgent request that contraindication warnings be listed for drug/biologic products based on the "Source of Excipients"

"What allergen restricts access to basic human requirements: fresh food, 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"

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

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

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-patients

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

https://cornallergyadvocacyresources.blogspot.com/2018/04/colleges-of-medicine-contacted-re.html

Colleges of Pharmacy Contacted Re: Protocol for Treating Corn-Allergic Patients

https://cornallergyadvocacyresources.blogspot.com/2018/05/colleges-of-pharmacy-contacted-re.html

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

https://cornallergyadvocacyresources.blogspot.com/2017/05/pharmaceutical-companies-contacted.html

Corn Allergy for Newbies

https://cornallergyadvocacyresources.blogspot.com/2019/08/corn-allergy-for-newbies.html

Corn Allergy: A Potentially Life-Threatening Diagnosis

https://cornallergyadvocacyresources.blogspot.com/2020/01/corn-allergy-potentially-life.html

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

https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-and-usda-confirm-that-corn-derived.html

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

https://cornallergyadvocacyresources.blogspot.com/2019/05/a-mothers-desperate-struggle-to-find.html

May, 2020, Month-End Corn Allergy Statistics: 935.2% Increase in 83 Months

(Corn is ubiquitous and corn allergen warnings are voluntary.)

https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Source:

Senators of the 116th Congress

https://www.senate.gov/general/contact_information/senators_cfm.cfm

United States House of Representatives 116th Congress

https://www.house.gov/representatives