FDA Cites Risks of Ceftriaxone (Rocephin) Mixed With Calcium

ROCKVILLE, Md., July 6 -- Calcium and ceftriaxone (Rocephin) are a dangerous combination that can increase the risk of lethal precipitates forming in the lungs and kidneys of infants, according to the FDA.

In a safety alert, the agency said it ordered changes to the ceftriaxone label following reports of "fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates."

The drug, a cephalosporin approved for a wide variety of infection, should not be reconstituted with calcium-containing solutions such as Ringer's or Hartmann's solution, nor should it be used in hyperbilirubinic neonates, said the FDA.

Using calcium-containing solutions to reconstitute ceftriaxone may increase the risk of particulate formation, according to Roche, which makes the drug.

Ceftriaxone should not be given concurrently with calcium-containing products, said Lars Birgerson, M.D., Ph.D., the vice-president of medicine affairs at Roche, in a letter to physicians.

Because some of the reported fatalities occurred "when the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed, the label has also been updated to include a warning against administering calcium-containing products within 48 hours of last administration of ceftriaxone," said Dr. Birgerson.

Moreover, he added, in-vitro studies have demonstrated that ceftriaxone can prevent bilirubin from binding to serum albumin, which may increase the risk of bilirubin encephalopathy.