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Tuesday, October 16, 2007

FDA issues US safety information for Rocephin (ceftriaxone sodium) after adverse incidents in neonates

Roche and the FDA have informed healthcare professionals of revisions to various sections of the US prescribing information for Rocephin™ (ceftriaxone) for injection, following new post-marketing information.

In the past few years, isolated neonatal deaths associated with calcium-ceftriaxone precipitates in the lungs and kidneys have been described worldwide. In some of these cases ceftriaxone and the calcium-containing solutions or medications were administered by different routes and at different times. For this reason, ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Calcium-containing solutions or products must not be administered within 48 hours of last administration of ceftriaxone.

In addition, new text has been added to more prominently reinforce that hyperbilirubinaemic neonates (especially prematures) should not be treated with Rocephin, as in vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin, and therefore bilirubin encephalopathy may develop in these patients.

More information is available from FDA Medwatch

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