The Food and Drug Administration has not licensed diphtheria antitoxin (DAT) for use in the United States. However, CDC is authorized to distribute DAT to physicians as an investigational new drug (IND).
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 toxigenic 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 Corynebacterium diphtheriae.
For more detailed information about case definitions and DAT use, see IND Protocol #4167, Use of DAT for Suspected Diphtheria Cases Cdc-pdf[18 pages].
U.S. physicians caring for a patient with suspected respiratory diphtheria can obtain DAT by contacting the CDC’s Emergency Operations Center at 770-488-7100 after consulting with their state health department. DAT is available from CDC under an Investigational New Drug (IND) protocol. A CDC diphtheria duty officer will discuss the protocol for DAT release with the physician. If the physician decides DAT is indicated, it will be dispatched from one of the U.S. Quarantine Stations. The physician makes the final decision on its use, may revise the diagnosis, and decide against administering DAT after it is released.
If you revise your patient’s diagnosis 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 30329
Phone: (404) 639-3717
- Use of DAT for Suspected Diphtheria Cases—Protocol Cdc-pdf[18 pages]
- Informed Consent/Parent Permission for Use of DAT for Suspected Diphtheria Cases Cdc-pdf[6 pages]
- Guide to Skin Testing for Sensitivity to DAT Cdc-pdf[8 pages]
- DAT Treatment and Adverse Effects—Worksheet Cdc-pdf[2 pages]
- Consent Form for Additional Blood Draws with Use of DAT Cdc-pdf[3 pages]
- Assent Form for Additional Blood Draws with Use of DAT – Age 7-11 Years Cdc-pdf[1 page]
- Assent Form for Additional Blood Draws with Use of DAT – Age 12-17 Years Cdc-pdf[2 pages]
- Investigator Statement Form—FDA 1572 Cdc-pdf[3 pages]
- Cover Letter to Physicians for DAT Release Cdc-pdf[2 pages]
- Diphtheria Investigation—Worksheet Cdc-pdf[2 pages]
- Information for Close Contacts of Diphtheria Patient—Worksheet Cdc-pdf[2 pages]
- Instructions for Specimen Collection and Transport for Laboratory Testing of Corynebacterium diphtheria and C. ulcerans Cdc-pdf[2 pages]
- Laboratory Specimen Submission Form (DASH Form)
- Diphtheria and the Alaskan Iditarod