The FDA’s June 30, 2021, reply to my June 28, 2021, email requesting their contact telephone number to provide to our clinicians verifying that dextrose is corn sugar

To:  FDA's Division of Drug Information, Center for Drug Evaluation and Research (CDER), druginfo@fda.hhs.gov

Date:  June 28, 2021

“Corn-allergic citizens should not be required to provide documentation to our clinicians that dextrose (corn sugar) is NOT "naturally present" in mammals, and dextrose-containing IV fluids can prove fatal to anyone with an IgE-mediated allergy to corn. 

I had surgery two weeks ago, and had to convince my surgeon that dextrose is corn sugar.  She originally told me that "dextrose is glucose."  However, the admitting nurse told me on the morning of my surgery that "dextrose is naturally present in humans."  She refused to review the documentation I brought with me prior to my surgery. Thankfully, dextrose-containing IV fluids were not administered to me during my hospitalization. 

This continues to be a major complaint by the nearly 15K members in our corn allergy support groups.  Therefore, we need to provide our clinicians with an FDA telephone number to call to verify that dextrose is corn sugar, and that dextrose is NOT "naturally present" in humans. 

Please provide us with an FDA emergency contact number to give to our clinicians to verify these facts. 

Thank you very much on behalf of corn-allergic citizens.”

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

 

June 30, 2021, reply to my email from Lindsay, Pharmacist, CDER

"Dear Diane H.,

Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

We are so sorry to learn that this happened and hope that your surgery went well. For drug information that is accessible 24/7, FDA offers prescribing information for FDA-approved drug products in the online databases Drugs@FDA [https://www.accessdata.fda.gov/scripts/cder/daf/] as well as https://labels.fda.gov/.  FDA does not offer emergency after-hours drug information services by phone. Our hours are Monday-Friday 8 am-4:30 pm except federal holidays. During those hours our drug information specialists can be reached at 855-543-3784 or 301-796-3400.

We agree that you should not have to fight to be heard as a patient. [emphasis added]  While the FDA does not regulate the practice of medicine or nursing, if you have not done so already, you may wish to submit a complaint to the State Medical Board for your surgeon and State Nursing Board for your admitting surgical nurse. Contact information for your state may be found from the Federation of State Medical Boards [https://www.fsmb.org/contact-a-state-medical-board/]  and National Council of State Boards of Nursing [https://www.ncsbn.org/contact-bon.htm].”

Best regards,

Lindsay
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov

 

Additional Resources/Documentation to Provide to Clinicians:

Dextrose is corn sugar, 21CFR184.1857, and can prove fatal to anyone with an IgE-mediated allergy to corn.
https://cornallergyadvocacyresources.blogspot.com/2021/06/dextrose-is-corn-sugar-21cfr1841857-and.html

Dextrose (Corn Sugar/D-Glucose) IV Solutions Contraindicated for Corn-Allergic Patients
https://cornallergyadvocacyresources.blogspot.com/2020/08/corn-sugar-dextrose-iv-fluids.html

Administering dextrose-containing IV fluids to corn-allergic patients is a critical medical error equivalent to administering penicillin to patients with an allergy to penicillin.  Guidelines for reporting medical professionals who administer corn sugar (dextrose/D-glucose) IV fluids to corn-allergic patients in direct violation of the contraindication warning in the package insert.
https://cornallergyadvocacyresources.blogspot.com/2019/12/lactated-ringers-in-5-dextrose.html

Blog Post Reference:

The FDA’s June 30, 2021, reply to my June 28, 2021, email requesting their contact telephone number to provide to our clinicians verifying that dextrose is corn sugar
https://cornallergyadvocacyresources.blogspot.com/2021/06/the-fdas-june-30-2021-reply-to-my-june.html