Introduction of routine zinc therapy for children with diarrhoea: evaluation of safety

On 8 May 2004, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommended routine administration of zinc in the management of children, aged less than five years, with acute diarrhoea. In making the recommendation, WHO and UNICEF also suggested careful monitoring for adverse events associated with routine administration of zinc, particularly unusual or excess vomiting. The study assessed, in a phase IV trial, i.e. post-marketing surveillance of zinc, the occurrence of adverse events during the first hour after the administration of the first dose of zinc in children with acute or persistent diarrhoea. The study was conducted at the Dhaka Hospital of ICDDR,B and at an outpatient clinic operated by a local health NGO-Progoti Samaj Kallyan Protisthan (PSKP), Dhaka, Bangladesh. Eligible children, aged 3-59 months, were treated with 20 mg of zinc sulphate provided in a dispersible tablet formulation. The children were observed for 60 minutes following the initial treatment with zinc for adverse events, with particular attention given to vomiting or regurgitation. During the one-year observation period, 42,440 children (male 57% and female 43%) received zinc, and 20,246 (47.8%) of them were observed. Regurgitation and/or vomiting occurred in 4,392 (21.8%) of the children; 90.8% of these children had vomiting only once, 8.7% twice, and 0.5% more than twice. No children revisited the hospital for recurrent vomiting following their discharge. A significant proportion of infants and children may experience vomiting or regurgitation, usually once, following the administration of the first dose of zinc. This is a transient phenomenon that did not impact on continuation of treatment with zinc.