Safety of sulfadoxine/pyrimethamine for intermittent preventive treatment of malaria in infants: evidence from large-scale operational research in southern Tanzania
Maokola, W.; Chemba, M.; Hamisi, Y.; Mrisho, M.; Shirima, K.; Manzi, F.; Masanja, M.; Willey, B.; Alonso, P.; Mshinda, H.; Tanner, M.; Schellenberg, J.R.M.Armstrong.; Schellenberg, D.
International Health 3(3): 154-159
2011
ISSN/ISBN: 1876-3413 PMID: 24038364 DOI: 10.1016/j.inhe.2011.03.009Document Number: 225328
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].
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