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From the Centers for Disease Control and Prevention
July 14, 2004

Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol

JAMA. 2004;292(2):166. doi:10.1001/jama.292.2.166
Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol

MMWR. 2004;53:413

Cases of respiratory diphtheria continue to occur sporadically among persons in the United States.1 Respiratory diphtheria is caused by toxigenic Corynebacterium diphtheriae (also, rarely, by toxigenic C. ulcerans) and frequently manifests insidiously as a membranous nasopharyngitis or obstructive laryngotracheitis accompanied by a low-grade fever. Respiratory diphtheria most often affects unvaccinated or inadequately vaccinated persons, particularly those who travel to areas where diphtheria is endemic and those who come into close contact with travelers from such areas.1 Effective treatment of respiratory diphtheria includes early administration of an equine diphtheria antitoxin (DAT). Delay in DAT administration can lead to life-threatening respiratory obstruction, myocarditis, and other complications. To ensure quick access to DAT, CDC maintains a stock of DAT for release to U.S. physicians.

No manufacturer has sought U.S. licensure of a DAT product since 1996. In 1997, an equine DAT product manufactured by Pasteur Merieux (Lyons, France) was made available in the United States through a Food and Drug Administration (FDA)–approved Investigational New Drug (IND) protocol.2 Production of this product ceased in 2002, and remaining supplies at CDC will expire on May 30, 2004.

To ensure the continued availability of DAT in the United States, CDC has procured an equine DAT product from the Instituto Butantan in Brazil. CDC will provide this product to U.S. physicians under an FDA-approved IND protocol. U.S. physicians caring for patients with suspected respiratory diphtheria can obtain DAT by contacting the diphtheria duty officer at CDC's Bacterial Vaccine Preventable Disease Branch in the Epidemiology and Surveillance Division of the National Immunization Program (telephone, 404-639-8257) from 8 a.m. to 4:30 p.m. Eastern time or from the Emergency Operations Center (telephone, 770-488-7100) at all other times. The duty officer will discuss the case and protocol with the physician and, if indicated, DAT will be rushed from one of eight U.S. Public Health Service quarantine stations. Respiratory diphtheria is a reportable disease; physicians should report any suspected case of respiratory diphtheria promptly to their local and state health departments.

References: 2 available