Diphtheria Antitoxin (DAT)
Diphtheria Antitoxin (DAT) is not licensed by the Food and Drug Administration (FDA) for use in the United States. However, CDC is authorized to distribute DAT to physicians as an Investigational New Drug (IND).
Who Receives Diphtheria Antitoxin (DAT)
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.
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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.
Download resources on assessing patients for diphtheria from the clinician page.
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 [12 pages].
U.S. physicians caring for patients with suspected respiratory diphtheria can obtain DAT by contacting the CDC’s Emergency Operations Center at 770-488-7100. The diphtheria duty officer at CDC's Meningitis and Vaccine Preventable Diseases Branch (MVPDB) 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. 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.
Health care providers in countries other than the U.S. or U.S. territories may directly contact the manufacturers of diphtheria antitoxin to procure supplies. Some currently known locations of DAT manufactures worldwide include:
How to Return Unused DAT
If your patient’s diagnosis is revised after the release of DAT and the diphtheria antitoxin 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
DAT Forms and Worksheets
- Use of DAT for Suspected Diphtheria Cases—Protocol [13 pages]
- Consent Form for Use of DAT for Suspected Diphtheria Cases [6 pages]
- Guide to Skin Testing for Sensitivity to Diphtheria Antitoxin [6 pages]
- DAT Treatment and Adverse Effects—Worksheet [1 pages]
- Consent Form for Additional Blood Draws with use of DAT [2 pages]
- Assent Form for Additional Blood Draws with use of DAT – Cases Aged 7-11 [1 page]
- Assent Form for Additional Blood Draws with use of DAT – Cases Aged 12-17 [2 pages]
- Investigator Statement Form—FDA 1572 [3 pages]
- Cover Letter to Physicians for DAT Release [2 pages]
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