Rocephin Plus Calcium Linked to Fatal Reactions: Warning Expanded

Yael Waknine

September 11, 2007 — The safety labeling for ceftriaxone sodium injection (Rocephin; Roche Pharmaceuticals, Inc) has been updated to describe the potential risks associated with concomitant use of calcium or calcium-containing solutions and products in patients of any age, the US Food and Drug Administration (FDA) advised healthcare professionals in a new alert today.
According to a letter to healthcare professionals from Roche, "the theoretical possibility exists for an interaction between ceftriaxone and IV calcium-containing solutions in patients other than neonates." Therefore, the use of ceftriaxone with calcium products is now contraindicated in all age groups.
Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys have been reported in both term and premature neonates, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Some of these cases occurred when ceftriaxone and the calcium-containing products were administered by different routes at different times.
In vitro studies have shown that ceftriaxone can displace bilirubin from binding to serum albumin, potentially leading to bilirubin encephalopathy, the FDA said. Use of ceftriaxone is therefore also contraindicated in hyperbilirubinemic neonates, both term and premature.
Because of the risk for particulate precipitation, ceftriaxone should not be mixed with calcium-containing solutions/products or reconstituted with calcium-containing diluents such as Ringer's or Hartmann's solution.
Concomitant administration of ceftriaxone with calcium-containing solutions or products is likewise contraindicated, even via different infusion lines; 48 hours should elapse between the last dose of ceftriaxone and their use.
Ceftriaxone injection is indicated for the treatment of lower respiratory tract infections, urinary tract infections, bacterial septicemia, skin and skin structure infections, bone and joint infections, pelvic inflammatory disease, uncomplicated gonorrhea, intraabdominal infections, acute bacterial otitis media, and meningitis caused by susceptible microorganisms. It also is approved for surgical prophylaxis in patients undergoing certain procedures classified as contaminated or potentially contaminated.