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Hundreds Of Infant Deaths Occur Every Year From Drug Reactions

The November 2002 issue of the journal Pediatrics reports that an average of 243 infant deaths occur each year from prescription drugs, biological products and other therapeutic agents.

The study involved case reviews of more than 500,000 adverse drug events (ADEs) occurring from November 1997 through December 2000. The study was performed by researchers at George Washington University and the University of Maryland. 7,111 of the ADEs reviewed involved children under the age of two.

The Authors found that in the 7,111 cases:

·    Only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly.
·    The drug palivizumab, used in high-risk pediatric patients, accounted for 28% of the adverse events.
·    Four drugs accounted for 38% of the reported deaths: palivizumab (15%), nitric oxide (11%), indomethacin (10%) and cisapride (3%). Even though widely used for gastroesophageal reflux in children, Cisapride was not approved for use in infants by the FDA. It was withdrawn from the U.S. market in 2000 because it was found to cause cardiac arrhythmia and sudden death.
·    In 24% of all the adverse events, exposure to the drug was from the mother during pregnancy, delivery or breast-feeding.
·    31% of the deaths occurred in the first month of life and 50% between day two and the 12^th month.

The authors say drug reactions in children are more likely “because young children have immature detoxification mechanisms and because doses must be individually adjusted for a much wider range of body size and weight.”

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