Diphtheria Antitoxin: How U.S. Doctors Get It From CDC

Diphtheria antitoxin (DAT) has been used for decades to treat diphtheria, but it is no longer produced in the United States. The Food and Drug Administration has authorized CDC to distribute it as an expanded access investigational new drug (EA-IND).

CDC’s Emergency Operations Center, which physicians contact to request DAT. Image from CDC’s page.

Who can receive it

Patients who meet the case definition for suspected or confirmed respiratory diphtheria are eligible. DAT may also be used for respiratory diphtheria-like illness caused by laboratory-confirmed toxigenic Corynebacterium ulcerans.

Eligibility for a particular patient is decided in a consultation between a CDC diphtheria duty officer and the treating physician.

The treating physician decides

Under FDA rules for expanded-access protocols, only the patient’s treating physician can request and give DAT. That physician:

• makes the final decision on using DAT
• may revise the diagnosis
• may decide not to give DAT even after it has been released

A physician who gives DAT becomes a co-investigator in the protocol and must report to CDC after treatment.

How to request it

1. Consult your state health department first.
2. Call CDC’s Emergency Operations Center at 770-488-7100.
3. Discuss the DAT release protocol with a CDC diphtheria duty officer.
4. Once the physician decides DAT is indicated, CDC ships it from one of the U.S. Port Health Quarantine Stations.

Returning unused antitoxin

If DAT is released but not given for any reason, it should be returned — shipped overnight in a cold pack to the CDC Drug Service at CDC headquarters in Atlanta.

Sources

Based on "Diphtheria Antitoxin," Centers for Disease Control and Prevention; a work of the United States government in the public domain.