Label Changes for:
Inomax (nitric oxide) for Inhalation
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009
WARNINGS AND PRECAUTIONS
- In patients with pre-existing left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- Patients who had pre-existing left ventricular dysfunction treated with inhaled nitric oxide, even for
short durations, experienced serious adverse events (e.g., pulmonary edema).