- Anaphylaxis in patients previously been exposed to protamine, including diabetic patients who have received protamine-containing insulin (eg, NPH, PZI), and individuals with fish allergy (protamine is derived from fish).
- Boxed Warning includes the following adverse events in patients who have previously received protamine sulfate or other protamine-containing drugs (e.g., NPH insulin, protamine zinc insulin, and certain beta-blockers):
- Cardiovascular collapse
- Non-cardiogenic pulmonary edema
- Catastrophic pulmonary vasoconstriction
- Pulmonary hypertension