Table 1

Contraindications and warnings for the use of drotrecogin alfa (activated)

Contraindications
Warnings

Active internal bleeding
Heparin >15 U/kg per hour
Recent (within 3 months) hemorrhagic stroke
International Normalized Ratio > 3
Recent (within 2 months) intracranial or intraspinal surgery or severe head trauma requiring hospitalization
Platelet count < 30,000/mm3, even if platelet count is increased after transfusions (USA) (European Agency for the Evaluation of Medicinal Products: contraindication)
Trauma with increased risk for life-threatening bleeding (e.g. liver, spleen or complicated pelvic fractures)
Recent gastrointestinal bleeding (within 6 weeks)
Patients with epidural catheters
Recent administration of thrombolytic therapy (within 3 days)
Patients with intracranial neoplasm or mass lesion, or evidence of cerebral herniation
Recent administration (< 7 days) of oral anticoagulant or glycoprotein IIb/IIIa inhibitors

Recent administration (< 7 days) of aspirin > 650 mg/day or other platelet inhibitors

Recent ischemic stroke (< 3 months)

Intracranial arteriovenous malformation

Known bleeding diathesis

Chronic severe hepatic disease (e.g. Child–Pugh C)

Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location

Adapted from US Food and Drug Administration [2,3].

Laterre and Wittebole Critical Care 2003 7:445   doi:10.1186/cc2342