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