Intravenous Ceftriaxone and Calcium in the Neonate: Assessing the Risk for Cardiopulmonary Adverse Events

Author:

Bradley John S.1,Wassel Ronald T.2,Lee Lucia3,Nambiar Sumathi4

Affiliation:

1. Rady Children's Hospital San Diego, San Diego, California

2. Office of Surveillance and Epidemiology

3. Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland

4. Office of New Drugs, Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

Abstract

OBJECTIVES. 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 ≤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.

Publisher

American Academy of Pediatrics (AAP)

Subject

Pediatrics, Perinatology and Child Health

Reference11 articles.

1. Food and Drug Administration. Information for healthcare professionals Ceftriaxone (marketed as Rocephin). Available at: www.fda.gov/CDER/DRUG/InfoSheets/HCP/ceftriaxone.htm. Accessed August 3, 2008

2. Food and Drug Administration. Rocephin (ceftriaxone sodium) for injection package label. Available at: www.fda.gov/cder/foi/label/2008/050585s050s060lbl.pdf. Accessed September 26, 2008

3. Available at: http://afssaps.sante.fr/htm/10/filltrpsc/lp061202.pdf. Accessed August 4, 2008

4. Food and Drug Administration. MedWatch. Available at: www.fda.gov/medwatch. Accessed October 1, 2008

5. Food and Drug Administration. Code of Federal Regulations, Title 21, Volume5. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80. Accessed September 26, 2008

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