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DEATHS IN NEWBORNS ASSOCIATED WITH USE OF ceftriaxone (rocephin)

The FDA has received seven case reports of serious cardiopulmonary adverse events in neonates associated with precipitation of a ceftriaxone-calcium salt in the lung and/or kidneys.  Six neonates have died. The children were aged 2 months and younger (range: 1 to 50 days), and treated with ceftriaxone for a variety of infections. The manufacturer and FDA issued a warning to health care professionals and revised the product labeling for the potential risk of concurrent administration of ceftriaxone and calcium.

According to the FDA, Ceftriaxone should not be used in neonates (<28 days of age) if they are receiving or expecting to receive calcium-containing intravenous products. In patients > 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. The FDA report states Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions in any age group.

Keywords: ceftriaxone, calcium, drug-drug interaction, cardiopulmonary arrest

FDA REPORT

Ceftriaxone (Rocephin) Product Label