Label Changes for:
Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1g and 2g
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009
- An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including Rocephin. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and ceftriaxone stopped until the etiology is determined.