Key points
- Diphtheria antitoxin (DAT) has been used for decades to treat diphtheria but is no longer produced in the United States.
- The Food and Drug Administration (FDA) has authorized CDC to distribute DAT as an expanded access investigational new drug (EA-IND).
Defining DAT eligibility
Patients who meet the case definition for suspect or confirmed respiratory diphtheria are eligible to receive DAT.
DAT may also be used in cases of respiratory diphtheria-like illness caused by laboratory-confirmed toxigenic Corynebacterium ulcerans.
CDC offers DAT consultations
DAT use is a clinical decision
FDA regulation of treatments given under EA-IND protocols mandate that only a patient's treating physician can request and administer DAT.
The treating physician
- Makes the final decision on DAT use
- May revise the diagnosis
- Can decide against administering DAT after it's released
If DAT is administered, the treating physician becomes a co-investigator in the DAT EA-IND. The treating physician must also provide reports to CDC following the patient's treatment.
Requesting DAT
A U.S. physician caring for an eligible patient should first consult with their state health department.
The treating physician can then obtain DAT by
- Contacting CDC's Emergency Operations Center (770-488-7100)
- Deciding that DAT is indicated
- Discussing the DAT release protocol with a CDC diphtheria duty officer
Once a treating physician determines that it is indicated, CDC dispatches DAT from one of the U.S. Quarantine Stations.
Returning unused DAT
If the antitoxin isn't given for any reason after it's released by CDC, then it should be returned. Ship it in a cold pack by overnight mail to:
CDC Drug Service (Mailstop H23-6)
Centers for Disease Control and Prevention
1600 Clifton Road, Atlanta Georgia 30329
Phone: (404) 639-3670
DAT forms and worksheets
Download a zip file [3.6 MB] with all the following documents or access each individually below:
- Cover letter to clinicians for DAT release
- Protocol: Use of DAT for suspected diphtheria cases
- Guide to skin testing for sensitivity to DAT
Appendices
- Appendix 1: Informed consent/parent permission for use of DAT
- Appendix 2: Close contact form
- Appendix 3: Diphtheria worksheet
- Appendix 4: DAT treatment and adverse effects form
- Appendix 5: Investigator statement form—FDA 1572
- Appendix 6: DAT product accountability and disposition form
- Appendices 7a: CDC IRB central memo and 7b: 4167 IRB continuation