Diphtheria Antitoxin
Diphtheria Antitoxin (DAT) is not licensed by the Food and Drug Administration for use in the United States. CDC is authorized to distribute DAT to physicians as an Investigational New Drug (IND).
On this page:
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.
Prophylactic Use
DAT is used prophylactically only under exceptional circumstances involving known or suspected exposure to toxigenic Corynebacteria.
For more detailed information about case definitions and DAT use, see IND Protocol #4167,"Use of Diphtheria Antitoxin (DAT) for Suspected Diphtheria Cases." 
[93 KB, 6 pages](Note: This protocol will be updated in May 2011.)
How to Request DAT
U.S. Sources
U.S. physicians caring for patients with suspected respiratory diphtheria can obtain DAT by contacting the Emergency Operations Center at 770-488-7100. The diphtheria duty officer at CDC's Meningitis and Vaccine Preventable Diseases (MVPD) Branch in the Division of Bacterial Diseases (DBD) of the National Center for Immunization and Respiratory Diseases (NCIRD) will discuss the case and protocol for DAT release with the physician and, if indicated, DAT will be dispatched from one of the U.S. Public Health Service quarantine stations. A patient's eligibility for treatment with DAT is determined by the treating physician in consultation with a CDC diphtheria duty officer. However, the treating physician makes the final decision on its use and may decide against administering DAT after it is released.
International Sources
Health care providers in countries other than the U.S. or U.S. territories may directly contact the manufacturers of diphtheria antitoxin to procure supplies. Some currently known locations of DAT manufactures worldwide include:
- Brazil: http://www.butantan.gov.br/home/
- Croatia: http://www.imz.hr/eng-proizvodi.htm
- Egypt: http://www.vacsera.com/Antisera.html
- India: http://www.seruminstitute.com/content/products/product_antisera_exp.htm
- Russia: http://www.microgen.ru
How to Return Unused DAT
If the patient’s diagnosis is revised after the release of DAT and the diphtheria antitoxin (DAT) 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 30333
Phone: (404) 639-3717
Forms and Worksheets
- Use of Diphtheria Antitoxin (DAT) for Suspected Diphtheria Cases [177 KB, 12 pages] Updated Feb 2012
- Informed Consent [78 KB, 6 pages] Updated Feb 2012
- Guide to Skin Testing for Sensitivity to Diphtheria Antitoxin [187 KB, 6 pages]
- CDC Diphtheria Worksheet [470 KB, 3 pages]
- Information for Close Contacts, Diphtheria [220 KB, 3 pages] Updated Feb 2012
- Diphtheria Antitoxin (DAT) Treatment and Adverse Effects [173 KB, 2 pages]
- Instructions for Specimen Collection and Transport for Laboratory Testing of Corynebacterium diphtheria and C. ulcerans [24 KB, 2 pages]
- Checklist for Assessing a Patient with Suspected Diphtheria [102 KB, 2 pages]
- DASH Form [296 KB, 3 pages]
- Statement of Investigator [31 KB, 3 pages]
- DAT - release cover letter to physicians [49 KB, 1 page]
Reading Resources
"Surveillance of Vaccine-Preventable Diseases" manual
- Updated Recommendations for the Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on Immunization Practices, 2010
MMWR January 14, 2011 / 60(01);13-15 - Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and their Infants
MMWR May 30, 2008 / 5(04);1-47 - Preventing Tetanus, Diphtheria, and Pertussis Among Adults:Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
MMWR December 15, 2006 / 55(RR17);1 - General Recommendations on Immunization
MMWR January 28, 2011 / 60(RR02);1-60 - Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents:Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines
MMWR March 24, 2006 / 55(RR3);1 - Fatal Respiratory Diphtheria in a U.S. Traveler to Haiti -- Pennsylvania, 2003
MMWR January 9, 2004 / 52(53);1285 - Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol
MMWR May 21, 2004 / 53(19);413 - Combination Vaccines for Childhood Immunization
MMWR May 14, 1999 / 48(RR05);1 - Toxigenic Corynebacterium diphtheriae -- Northern Plains Indians
MMWR June 6, 1997 / 46(22);506 - Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use
MMWR August 8, 1991 / 40(RR10);001
Other Resources
- List of quarantine stations
- Immunization program managers
- List of State Epidemiologists
- State Health Departments
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Content last reviewed on February 7, 2011
Content Source: National Center for Immunization and Respiratory Diseases