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Department of Health and Human Services
Centers for Disease Control and Prevention


Vaccines & Immunizations

Diphtheria Antitoxin

Diphtheria Antitoxin (DAT) is not licensed by the Food and Drug Administration for use in the United States. CDC is authorized to distribute DAT to physicians as an Investigational New Drug (IND).

Who Should Received DAT?

Therapeutic Use

Patients who have probable or confirmed respiratory diphtheria are eligible to receive DAT.

Clinical Respiratory Diphtheria is defined as an upper respiratory tract illness characterized by sore throat, a low grade fever, and an adherent membrane of the tonsil(s), pharynx, larynx, and/or nose.

A confirmed case is either a clinical case from which Corynebacterium diphtheriae is isolated or a clinical case that is epidemiologically linked to a laboratory-confirmed case.

A probable case is a clinically compatible case that is not laboratory confirmed and is not epidemiologically linked to a laboratory-confirmed case.

Prophylactic Use

DAT is used prophylactically only under exceptional circumstances involving known or suspected exposure to toxigenic Corynebacteria.

For more detailed information about case definitions and DAT use, see IND Protocol #4167, "Use of Diphtheria Antitoxin (DAT) for Suspected Diphtheria Cases." Adobe Acrobat print-friendly PDF file

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How to Request DAT

U.S. physicians caring for patients with suspected respiratory diphtheria can obtain DAT by contacting the Emergency Operations Center at 770-488-7100. The diphtheria duty officer at CDC's Meningitis and Vaccine Preventable Diseases (MVPD) Branch in the Division of Bacterial Diseases (DBD) of the National Center for Immunization and Respiratory Diseases (NCIRD) will discuss the case and protocol for DAT release with the physician and, if indicated, DAT will be dispatched from one of the U.S. Public Health Service quarantine stations. A patient's eligibility for treatment with DAT is determined by the treating physician in consultation with a CDC diphtheria duty officer. However, the treating physician makes the final decision on its use and may decide against administering DAT after it is released.

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How to Return Unused DAT

If the patient’s diagnosis is revised after the release of DAT and the diphtheria antitoxin (DAT) is not given to the patient, then it should be returned in a cold pack by overnight mail to:

CDC Drug Service (Mailstop D-09)
Centers for Disease Control and Prevention
1600 Clifton Road, Atlanta Georgia 30333
Phone: (404) 639-3717

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Forms and Worksheets

DAT IND Protocol (FDA Approved)
Consent Form
Sensitivity (Skin Testing)
Diphtheria Investigation Worksheet
  • print version
    (Appendix 3 is currently being updated Please check back often. If you wish to be notified by email when this web page is updated and hence when appendices are added, please use the Get Email Updates link located at the top of the Manual for Surveillance of VPD web page.
  • Not acceptable for screen-reader devices, please contact NIPINFO@cdc.gov for immediate assistance.
Close Contacts Worksheets
Adverse Events Worksheets
Laboratory Instructions for Specimen Collection and Transportation
Diphtheria Diagnosis Checklist
Provides some guidance on the factors to consider while assessing the probability of respiratory diphtheria, and a list of other disease agents to consider in the differential diagnosis of respiratory diphtheria
Laboratory DASH Form
Investigator-Statement-Form-FDA-1572
DAT - Release Cover Letter to Physicians 

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Reading Resources

Pink Book's chapter on diphtheria
("Epidemiology and Prevention of Vaccine-Preventable Diseases" textbook)
Surveillance manual's chapter on diphtheria

"Surveillance of Vaccine-Preventable Diseases" manual

MMWR Articles

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Other Resources

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This page last modified on September 17, 2008
Content last reviewed on July 6, 2007
Content Source: National Center for Immunization and Respiratory Diseases

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