An average of 243 children under the age of 2 years die each year in the United States as a result of drugs used during the perinatal period. Seventeen drugs accounted for more than half of all cases of serious and fatal adverse events in children treated directly with them.
The analysis was based on 7111 reports of adverse drug reactions in infants and children between November 1997 and December 2000. The reports were culled from more than 500000 MedWatch adverse event reports that doctors and drug companies are required to file with the US Food and Drug Administration.
The reports were analysed for outcome (death, hospital admission, and congenital abnormality), principal suspect drug, and whether the route of exposure was direct administration or from the mother in the perinatal period.
The analysis, which has been published in Pediatrics on the web ahead of print publication (www.pediatrics.org/cgi/content/full/110/5/e53), was carried out by Dr Thomas Moore and colleagues at George Washington University, Washington, DC.
Of the average 243 deaths a year associated with drug treatment, 100 (41%) occurred during the first month of life and 204 (84%) during the first year.
In a fifth of all reported adverse events, exposure to the drug was through the mother during pregnancy, delivery, or breast feeding. Congenital abnormality or disability was the most common outcome, occurring in 41% of the reported cases.
Four drugs accounted for 38% of all 769 reported deaths: the monoclonal antibody palivizumab (113 cases; 15%), nitric oxide (87 cases; 11%), intravenous indometacin (78 cases; 10%), and cisapride (24 cases; 3%). Cisapride was widely used to treat infants with gastro-oesophageal reflux but was withdrawn from the market in 2000.