Update: Availability of Sulfadiazine -- United States
Sulfadiazine is a sulfa drug commonly used in combination with
pyrimethamine to treat toxoplasmosis in patients with acquired
immunodeficiency syndrome (AIDS) and newborns with congenital
infections. In December 1992, CDC reported that the domestic
manufacturer of sulfadiazine had ceased production in October 1992
and that no large inventories of the drug were available from major
distributors (1). On February 8, CDC obtained permission from the
Food and Drug Administration (FDA) to proceed with an
"Investigational New Drug" (IND) application protocol under which
sulfadiazine may be imported and made available to physicians until
a domestic commercial source is re-established.
The drug will be available from CDC beginning February 16 at
no cost for the treatment of acute infection and for maintenance
therapy of suspected or proven toxoplasmosis in persons with AIDS,
persons with ocular disease, pregnant women who are infected, and
congenitally infected infants. Pregnant women in the second and
third trimester and infants must have an elevated Toxoplasma IgM
titer before sulfadiazine can be released under this IND protocol.
The drug will not be available under the CDC IND application
protocol for primary prophylaxis of toxoplasmosis.
A 6-week supply of sulfadiazine will be provided for treatment
of acute infection in persons with AIDS, ocular infection, and
infection in pregnant women; a 2-month refillable supply will be
provided for treatment of infection in congenitally infected
infants and for maintenance therapy in persons with AIDS.
Clinicians who would like to obtain sulfadiazine for patients must
provide CDC with clinical and laboratory information about the
patient, including Toxoplasma antibody titers, and a complete
shipping address for their hospital or practice. CDC will not
record patient names; instead, each patient will be assigned a
computer-generated identification number that must be used to
obtain additional drug supplies without having to re-enroll the
patient. Having the patient's medical record available when
contacting CDC will facilitate the initial drug release process. An
IND information package will accompany the released drug.
Large hospitals or practices that wish to enroll several
patients should consider designating one principal physician to
serve as the clinical investigator for the facility. This person
would ensure that all terms of the IND are adhered to by other
physicians using the drug in the same facility. Requests should be
directed to CDC's Division of Parasitic Diseases, National Center
for Infectious Diseases, telephone (404) 488-4928.
Reported by: Div of Antiviral Drug Products, Center for Drug
Evaluation and Research, Food and Drug Administration. Scientific
Resources Program, and Div of Parasitic Diseases, National Center
for Infectious Diseases, CDC.
Reference
CDC. Availability of sulfadiazine--United States. MMWR
1992;41:950-1.
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