Diphtheria Antitoxin

For Health Professionals

Diphtheria antitoxin (DAT) is not licensed by the Food and Drug Administration for use in the United States. However, CDC is authorized to distribute DAT to physicians as an investigational new drug (IND).

 

Who Should Receive 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.

Download resources on assessing patients for diphtheria from the clinician page.

Prophylactic Use

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 [18 pages].

 

Requesting DAT

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. DAT is available from CDC under an Investigational New Drug (IND) protocol. The 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 treating physician makes the final decision on its use and may decide against administering DAT after it is released.

 

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 30329
Phone: (404) 639-3717

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DAT Forms and Worksheets

• Use of DAT for Suspected Diphtheria Cases—Protocol [18 pages]
• Informed Consent/Parent Permission for Use of DAT for Suspected Diphtheria Cases [6 pages]
• Guide to Skin Testing for Sensitivity to DAT [8 pages]
• DAT Treatment and Adverse Effects—Worksheet [2 pages]
• Consent Form for Additional Blood Draws with Use of DAT [3 pages]
• Assent Form for Additional Blood Draws with Use of DAT – Age 7-11 Years [1 page]
• Assent Form for Additional Blood Draws with Use of DAT – Age 12-17 Years [2 pages]
• Investigator Statement Form—FDA 1572 [3 pages]
• Cover Letter to Physicians for DAT Release [2 pages]