Label Changes for:
Cyanokit (hydroxocobalamin) intravenous use
October 2010
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010
USE IN SPECIFIC POPULATIONS
Pregnancy
- Based on animal studies, may cause fetal harm; however, treatment of maternal/fetal cyanide poisoning may be lifesaving.
Nursing mothers
- Because of the unknown potential for adverse reactions in nursing infants, discontinue nursing after Cyanokit treatment
