ArticleMalaria journal2026
Incidence and trends of adverse drug reactions during seasonal malaria chemoprevention among children: evidence from Ghana's pharmacovigilance database, 2015-2023.
Article in Malaria journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundSeasonal Malaria Chemoprevention, which involves giving sulphadoxine-pyrimethamine and amodiaquine (SPAQ) to children aged 3-59 months, is a key strategy for preventing malaria in Ghana. Although SPAQ has been used since 2015, systematic evidence on adverse drug reactions remains limited. This study assessed the patterns and incidence of ADRs associated with SMC to guide safety practices, strengthen public trust, and inform policy. MATERIALS AND
methodsWe analyzed SPAQ-related ADRs reported to the Ghana Food and Drugs Authority (FDA) database between 2015 and 2023 using STATA IC 16. Incomplete records were excluded. ADRs were classified by age, sex, seriousness, and reporter category, with serious cases further categorized by outcomes such as hospitalization and death. Consistent classification was ensured with standardized MedDRA coding. Annual incidence per 100,000 SPAQ doses was calculated using ADR reports and dispensing data from the National Malaria Elimination Programme.
resultsA total of 2,097 ADRs were analyzed. Slightly more than half (51.2%) involved male children, and 60.3% occurred among those aged 13-59 months. The most frequently reported ADRs were fever (22.7%), vomiting (21.5%), and diarrhoea (16.9%). Serious reactions accounted for 8.6% of cases, most often leading to prolonged hospitalization. The incidence of ADRs declined from 220.63 per 100,000 doses in 2015 to 0.34 in 2023. Caregivers/non-healthcare professionals submitted two-thirds of reports.
conclusionSMC with SPAQ is generally safe in Ghana, though serious ADRs continue to occur. The low reporting rate by healthcare professionals, contrasted with high reporting by caregivers, underscores the need to enhance professional engagement, ensure accurate community reporting, and expand active surveillance during SMC campaigns.
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