Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events.
OBJECTIVE
Unsolicited reports regarding potentially serious adverse drug reactions in neonates and young infants were reported to the Food and Drug Administration, leading to changes in the package label for ceftriaxone. This report describes and summarizes the reported cases that led to safety concerns regarding the concurrent administration of intravenous ceftriaxone and calcium in this age group.


METHODS
Nine reported cases were assessed. The Food and Drug Administration Adverse Event Reporting System database was searched for potential drug interactions in patients who were receiving concomitant ceftriaxone and calcium therapy.


RESULTS
Eight of the reported 9 cases (7 were < or =2 months of age) represented possible or probable adverse drug events. There were 7 deaths. None of the cases were reported from the United States. The dosage of ceftriaxone that was administered to 4 of 6 infants for whom this information was available was between 150 and 200 mg/kg per day. The rate of occurrence of these serious adverse drug reactions cannot be accurately determined from available data.


CONCLUSIONS
The concurrent use of intravenous ceftriaxone and calcium-containing solutions in the newborn and young infant may result in a life-threatening adverse drug reaction. Contributing factors for infants in this report may include the use of ceftriaxone at dosages higher than those approved by the Food and Drug Administration, intravenous "push" administration, and administration of the total daily dosage as a single infusion.
Bradley
John S
JS
Rady Children's Hospital San Diego, San Diego, California 92123, USA. jbradley@rchsd.org
Wassel
Ronald T
RT
Lee
Lucia
L
Nambiar
Sumathi
S
D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002125:Calcium Gluconate / Q000008:administration & dosage* / Q000009:adverse effects*; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D006323:Heart Arrest / Q000139:chemically induced*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D010289:Parenteral Nutrition, Total
D000900:Anti-Bacterial Agents; D002443:Ceftriaxone; D002125:Calcium Gluconate