Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009
WARNINGS AND PRECAUTIONS
Serious Meningococcal Infections
- Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.
- In clinical studies among non-PNH patients, meningococcal meningitis occurred in one patient, who was unvaccinated.
- Cases of serious or fatal meningococcal infections have been reported.