[Acute hepatitis following administration of fansidar]

Since 1971 pyrimethamine-sulfadoxine (Fansidar, Roche) has been used worldwide for prophylaxis and therapy of chloroquine resistant Plasmodium falciparum malaria. The drug monitoring team of the producing firm has received reports of a number of cutaneous adverse reactions, some severe, and a few even with fatal outcome. Liver reactions were also encountered, with severe cases only in the recent literature. We report on two patients with hepatitis in temporal relationship to pyrimethamine-sulfadoxine, the first with a second event after later exposure to the same drug. After discontinuing the medication the liver function abnormalities returned to normal limits within a few weeks. Liver biopsy and a positive lymphocyte transformation test against sulfadoxine, a component of Fansidar, strongly suggest that Fansidar was the cause of hepatic injury.