Safety of sulfadoxine/pyrimethamine for intermittent preventive treatment of malaria in infants: evidence from large-scale operational research in southern Tanzania.

Intermittent preventive treatment with sulfadoxine/pyrimethamine (SP) is recommended for malaria prevention in infants (IPTi-SP). Serious adverse events, including Stevens-Johnson syndrome (SJS), have been reported following exposure to SP, but few infant-specific data exist. The safety of IPTi-SP was evaluated as part of a pilot implementation programme in southern Tanzania using three methods: spontaneous adverse event reporting to capture suspected adverse drug reactions (ADR); a census survey documenting rash-related hospital admissions among children < 2 years of age; and verbal autopsies (VA) completed for rash-related deaths in 2-11-month-olds. Approximately 82 000 IPTi-SP doses were administered to approximately 29 000 children. In total, 119 suspected ADRs were reported, 13 in children aged