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Label Changes for:

Inomax (nitric oxide) for Inhalation

August 2009

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


Heart Failure
  • 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).