title: Cardiorespiratory arrests temporally associated with injection of intravenous ampicillin in infants: investigation of a suspected cluster.
abstract: In August 1985, the FDA received reports of infants who had cardiorespiratory arrests associated with a widely used IV ampicillin product. The events occurred during July and August 1985 in three hospitals located in different parts of the United States. To assess the possibility of a product defect, an epidemiologic investigation was undertaken to determine whether the suspect ampicillin product was associated with an excess number of serious adverse events among infants in 1985. Because complete ampicillin brand information was unavailable for two of the three hospitals, a nonconcurrent cohort study was conducted to test whether the proportion of serious adverse events among infants who were hospitalized between July 1 and Aug 23, 1985, and exposed to any brand of IV ampicillin was different from the proportion of serious adverse events among infants who were hospitalized during the same time in 1984 and exposed to IV ampicillin. No statistically significant difference was found. A follow-up incidence density study at the hospital for which complete ampicillin brand information was known determined that the suspect ampicillin product was not associated with an increased number of serious adverse events in 1985. No common lots of the suspect ampicillin product were identified at the three hospitals. It was concluded that the suspect ampicillin product was not the cause of the cluster of serious adverse events observed among infants in July and August 1985 based on epidemiologic findings.
authors: Center for Drugs and Biologics, Food and Drug Administration, Rockville, Maryland 20857.
authors: W L
authors: WL
authors: Nelson
authors: R
authors: R
authors: Wise
authors: J N
authors: JN
authors: Kuritsky
mesh_terms: D000667:Ampicillin / Q000008:administration & dosage / Q000009:adverse effects*; D002423:Cause of Death; D002648:Child; D005069:Evaluation Studies as Topic; D005839:Gentamicins / Q000008:administration & dosage; D006323:Heart Arrest / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007275:Injections, Intravenous; D011358:Product Surveillance, Postmarketing; D013029:Space-Time Clustering; D014481:United States
chemical_list: D005839:Gentamicins; D000667:Ampicillin