title: Safety of sulfadoxine/pyrimethamine for intermittent preventive treatment of malaria in infants: evidence from large-scale operational research in southern Tanzania.
abstract: 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 <2 years, only one of whom had received IPTi-SP. The census involved 243 612 households. Only one rash-related admission was reported amongst 1292 children aged 2-11 months, but this child had no history of exposure to SP. Moreover, 30 of 699 deaths in 2-11-month-olds were said to have been associated with a skin rash. The rates of rash-associated death were 0.59/1000 person-years at risk (PYAR) and 1.17/1000 PYAR in intervention and comparison areas, respectively (P = 0.79). VAs did not suggest SJS or any other ADR. We conclude that IPTi-SP is associated with a very low incidence of severe skin reactions. [ClinicalTrials.gov identifier: NCT00152204].
authors.affiliation: Ifakara Health Institute, Ifakara, Tanzania.
authors.forename: Werner
authors.initials: W
authors.lastname: Maokola
authors.forename: Mwajuma
authors.initials: M
authors.lastname: Chemba
authors.forename: Yuna
authors.initials: Y
authors.lastname: Hamisi
authors.forename: Mwifadhi
authors.initials: M
authors.lastname: Mrisho
authors.forename: Kizito
authors.initials: K
authors.lastname: Shirima
authors.forename: Fatuma
authors.initials: F
authors.lastname: Manzi
authors.forename: Mary
authors.initials: M
authors.lastname: Masanja
authors.forename: Barbara
authors.initials: B
authors.lastname: Willey
authors.forename: Pedro
authors.initials: P
authors.lastname: Alonso
authors.forename: Hassan
authors.initials: H
authors.lastname: Mshinda
authors.forename: Marcel
authors.initials: M
authors.lastname: Tanner
authors.forename: Joanna R M Armstrong
authors.initials: JR
authors.lastname: Schellenberg
authors.forename: David
authors.initials: D
authors.lastname: Schellenberg