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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

  1. CDC. Availability of sulfadiazine--United States. MMWR 1992;41:950-1.

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