(Updated April 3, 2020)
After discovering that
Drugs.com and Mayo Clinic have classified dextrose (corn sugar) as a drug, I
posted the following question on the FDA's March 2, 2020, Facebook thread
entitled "FDA Grand Rounds."
"Since when was dextrose
classified as a drug? It is corn sugar [per Code of Federal Regulation 21CFR184.1857]
that is added to drug products, and is always contraindicated for corn-allergic
patients."
The FDA's reply to my post,
which confirms the FDA’s attempt to classify corn sugar as a "drug."
"There are multiple FDA
approved dextrose injectable solution drug products (alone and in combination
with other ingredients). Drugs are defined by law, in part, by their intended use
as "articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease" and "articles (other than food)
intended to affect the structure or any function of the body of man or other
animals”. You can find FDA approved drugs in our Drugs@FDA database:
As noted in the labeling for
dextrose, it is used for replenishment of fluid and calories as required by the
clinical condition of the patient: [Note
the FDA is referencing the package insert from Baxter Laboratories for IV
fluids to which dextrose (corn sugar) has been added.]
If you have additional
questions or comments please feel free to contact us directly via email (DDIFB@fda.hhs.gov)
or phone 1-855-543-3784."
___________________________________________________
Date: March 5, 2020
[NOTE:
An FDA representative (Tuan) told me in our telephone conversation this
afternoon that dextrose (corn sugar) is a stand-alone drug product.]
As the FDA is aware, dextrose (corn sugar) can prove fatal to the anaphylactic
corn-allergic consumer/patient; e.g., we must avoid any food products
containing dextrose (corn sugar), such as iodized salt, as well as any drug
products containing dextrose (corn sugar), such as intravenous fluids. In
fact, IV fluids, to which dextrose (corn sugar) has been added, are
contraindicated for corn-allergic patients; therefore, the only safe-for-us
intravenous fluid is saline-only IV fluid to which dextrose (corn sugar) has
not been added.
The FDA is also aware that
dextrose (corn sugar) is not classified as a drug; but is an ingredient
added to drugs. If dextrose (corn sugar) were classified as a drug,
consumers would be prohibited from purchasing food products containing
dextrose (corn sugar) without a prescription; e.g., iodized salt.
After a physician told a
member of one of our corn allergy groups that "No one can be allergic to
dextrose," he proceeded to administer dextrose IV fluid to this
corn-allergic patient in direct violation of the contraindication warning on
the package insert which caused a severe allergic reaction requiring emergency
intervention -- even though the patient's allergy to corn was clearly
documented in her medical records. In an effort to educate medical
professionals about the dangers of dextrose for the safety of corn-allergic
patients, I then forwarded the following documents to the majority of our
nation's hospitals, colleges of medicine, and colleges of pharmacy. This
effort took me three years, yet we continue to receive reports from our corn
allergy group members that physicians remain oblivious to the dangers of
administering dextrose IV fluids to corn-allergic patients.
Baxter Labs specifically warns about administering dextrose IV fluids to
corn-allergic patients.
"Solutions containing dextrose should be used with caution, if at
all, in patients with known allergy to corn or corn products." - Page 3
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf
Potential Danger to Corn-Allergic Patients:
I believe I may have discovered
the sources of this misinformation; e.g., Drugs.com actually lists dextrose
(corn sugar) as a stand-alone drug, and is equating dextrose with glucose
(blood sugar).
In addition, Mayo Clinic is
also classifying dextrose (corn sugar) as a stand-alone drug; however, the
majority of well-respected drug reference sites do not classify dextrose (corn
sugar) as a stand-alone drug, understanding that dextrose (corn sugar) in an
ingredient added to drug products.
If you reference “Dextrose”
(corn sugar) on Wikipedia, the reader is directed to “Glucose” (blood sugar). Again, glucose is the sugar in blood, and
dextrose is the sugar derived from cornstarch which can prove fatal to the
anaphylactic corn-allergic patient/consumer.
https://en.wikipedia.org/wiki/Glucose
Therefore, if medical
professionals reference Drugs.com, Mayo Clinic, or Wikipedia websites, this
would explain their lack of adequate knowledge that dextrose (corn sugar
derived from cornstarch) is contraindicated for corn-allergic
patients.
BCPharmacists, "Warning: corn-related allergens . . ."
"The situation A pharmacist and physician worked to
find what they believed was a suitable product for a patient with a severe corn
allergy; part of their research involved checking the product’s CPS monograph,
which didn’t indicate corn derivatives. After being told that the product did
not contain corn products, the patient took the drug while still in the
pharmacy and proceeded to drive to work. Approximately 10 minutes later she
started to have breathing problems and had to pull off the highway and
administer emergency anaphylactic medication. She went to a hospital and was
administered an IV solution, but the problem wasn’t solved: her blood pressure
kept dropping and she was still having problems breathing. In this situation,
both drugs the patient received had corn-based ingredients. (emphasis
added)
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf
Inconsistent Definitions
of Dextrose (Corn Sugar Derived from Cornstarch):
Drugs.com
[Dextrose
is NOT a drug, but is corn sugar derived from cornstarch that is ADDED to drug
products and food products; e.g., IV fluids and iodized salt; and is
contraindicated for corn-allergic patients/consumers.]
As posted on the Drugs.com website:
"Generic Name:
glucose (oral/injection) (GLOO kose)
Brand Names: Dextrose
What is Dextrose?
Dextrose (glucose) is a
form of natural sugar that is normally produced by the liver."
1. Glucose (blood sugar) is NOT the generic name of
dextrose (corn sugar), and glucose (blood sugar) is not a drug.
2. Dextrose (corn sugar) is NOT a "brand
name," and is not a drug.
3. Dextrose is corn sugar manufactured from
cornstarch, and is NOT produced by the liver.
4. Glucose is blood sugar, and is NOT to be equated
with dextrose (corn sugar) which can prove fatal to corn-allergic
patients/consumers.
Mayo Clinic
rxlist.com
"CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with known
allergy to corn or corn products." [THIS IS DUE TO THE FACT THAT DEXTROSE
IS CORN SUGAR AND CAN PROVE FATAL TO CORN-ALLERGIC PATIENTS. IT IS AN
ADDED INGREDIENT TO THIS DRUG PRODUCT.]
https://www.rxlist.com/dextrose-electrolytes-no-48-drug.htm#medguide
MedlinePlus
does NOT list dextrose as a stand-alone drug, because dextrose is the sugar
derived from cornstarch that is ADDED to drug products.
Physician’s Desk Reference (PDR) does NOT list dextrose as a stand-alone drug, because
dextrose is the sugar derived from cornstarch that is ADDED to drug products.
For the safety of all corn-allergic patients, we recommend consistency in
labeling; e.g., all drug products, to which dextrose (corn sugar) has been
added, should contain a contraindication warning for administration to
corn-allergic patients.
In addition, Drugs.com and Mayo Clinic should immediately remove
"Dextrose" as a “stand-alone drug.”
PLEASE NOTE THAT DEXTROSE (CORN
SUGAR DERIVED FROM CORNSTARCH) IS NOT A STAND-ALONE DRUG, BUT IS AN INGREDIENT ADDED
TO THESE REFERENCED DRUG PRODUCTS:
For the safety of
corn-allergic patients and consumers, we greatly appreciate your efforts on our
behalf by clearly defining dextrose as corn sugar (per Code of Federal
Regulation 21CFR184.1857) as an added ingredient to drug products.
If, on the other hand, the FDA defines dextrose (corn sugar) as a “drug,"
please provide me with the documentation for the designation of dextrose (corn
sugar) as a “stand-alone drug product.”
Thank you for your attention
to this critical concern.
Diane H., Corn Allergy
Advocate
Corn Allergy
Advocacy/Resources
Twitter:
@CornAllergy911
References:
Corn Products/Ingredients to Avoid if Allergic to
Corn; e.g, DEXTROSE (CORN SUGAR)
Published Corn Allergy Studies/Statistics (“. . . Maize major allergen . . .”)
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
--------------------------------------------------------------
The FDA’s March 11, 2020, Reply to My Email:
Dear Diane H.
Thank you for writing the Division of Drug Information, in the
FDA’s Center for Drug Evaluation and Research.
We have determined that your inquiry requires additional
consultation time and research to ensure an accurate and complete response. We
will respond as soon as we can. Thank you in advance for your patience.
Best Regards,
HT
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
----------------------------------------------------------------
Update April 3, 2020
In
my telephone conversation this afternoon with Connie, FDA pharmacist, she also
stated that dextrose is a "stand-alone drug product." When I asked her for the NDC product code
confirming her statement, she referenced NDC Product Code 51662-1211-1.
Note that this NDC Product Code is for
the “Labeler,” Hf Acquisition Co Llc, Dba Healthfirst;" and they are
distributors of medical products. They
are not a pharmaceutical company.
Disclaimer on this website:
"The
NDC Directory contains ONLY information on final marketed drugs submitted to
FDA electronically by labelers. A labeler might be a manufacturer, re-packager
or re-labeler. The product information included in the NDC directory does not
indicate that FDA has verified the information provided by the product labeler.
Assigned NDC numbers are not in any way an indication of FDA approval of the
product."
In
addition to speaking with Connie, I also forwarded this critical information to
Wolters Kluwer Health, American Society of Health-System Pharmacists, Cerner
Multum and IBM Watson Micromedex, since Drugs.com states that the information
on their database: “. . . is powered by
four independent leading medical-information suppliers: Wolters Kluwer Health,
American Society of Health-System Pharmacists, Cerner Multum and IBM Watson
Micromedex.”
“The
Drugs.com Database
The
Drugs.com Drug Information Database is powered by four independent leading
medical-information suppliers: Wolters Kluwer Health, American Society of
Health-System Pharmacists, Cerner Multum and IBM Watson Micromedex. Individual
drug (or drug-class) content compiled by these sources is peer reviewed and
delivered by Drugs.com.”
