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New warning for Rocephin

Executive Summary

Labeling for Roche's Rocephin (ceftriaxone) has been strengthened to warn against concomitant use with calcium-containing solutions or products in newborns based on adverse events reported during postmarketing clinical use of the anti-infective. Isolated neonatal deaths were associated with calcium-ceftriaxone precipitates in the lungs and kidneys, according to a "Dear Doctor" letter sent in June. Labeling also has been reinforced to contraindicate against use in hyperbilirubinemic neonates...

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