Inomax (nitric oxide) for Inhalation
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).