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 treating clinicians as an investigational new drug (IND).
Patients who have suspect or confirmed respiratory diphtheria, according to the Council of State and Territorial Epidemiologists case definition, are eligible to receive DAT. DAT may also be used in cases of respiratory diphtheria-like illness caused by laboratory-confirmed toxigenic C. ulcerans. A patient’s eligibility for treatment will be determined through discussion between the CDC diphtheria duty officer and the treating clinician.
U.S. clinicians caring for a patient with possible 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 IND protocol. A CDC diphtheria duty officer will discuss the protocol for DAT release with the treating clinician. If the clinician decides DAT is indicated, it will be dispatched from one of the U.S. Quarantine Stations. The clinician makes the final decision on its use, may revise the diagnosis, and decide against administering DAT after it is released.
If the clinician revises the patient’s diagnosis after the release of DAT and the antitoxin is not given, then it should be returned 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
Download a zip file [3.6 MB] with all the following documents or access each individually below:
- Cover Letter to Clinicians for DAT Release
- Use of DAT for Suspected Diphtheria Cases—Protocol
- Appendix 1: Informed Consent/Parent Permission for Use of DAT for Suspected Diphtheria Cases [6 pages]
- Appendix 2: Close Contact Form [3 pages]
- Appendix 3: Diphtheria Worksheet [3 pages]
- Appendix 4: DAT Treatment and Adverse Effects Form [2 pages]
- Appendix 5: Investigator Statement Form—FDA 1572 [2 pages]
- Appendix 6: DAT Product Accountability and Disposition Form [1 page]
- Appendix 7: CDC IRB Central Memo [1 page]
- Appendix 7: 4167 IRB Continuation [1 page]
- Guide to Skin Testing for Sensitivity to DAT [8 pages]
- Clinician Resource: Key Questions to Consider when Assessing Suspected Respiratory Diphtheria [1 page]