Healthy Skepticism Library item: 17885

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Publication type: Journal Article

Gottlieb S
Serious adverse events associated with perinatal drugs
BMJ 2002 Nov 16; 325:(7373):1132
http://www.bmj.com/cgi/content/extract/325/7373/1132

Abstract:

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 500 000 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 . . .