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. 2024 Mar 11;15:1352982. doi: 10.3389/fphar.2024.1352982

TABLE 3.

Approved contraindications for fondaparinux in different countries or regions.

Contraindications
China NMPA ①Patients known to have hypersensitivity to fondaparinux sodium or any excipient in the formulation;
②Patients with clinically significant active bleeding;
③Patients with acute bacterial endocarditis;
④Patients with severe renal impairment, defined as a creatinine clearance <20 mL/min
Europe EMA ①Patients with severe renal impairment (creatinine clearance <30 mL/min);
②Patients with body weight <50 kg;
③Patients with active major bleeding, bacterial endocarditis;
④patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium;
⑤patients with known hypersensitivity to fondaparinux sodium
US FDA ①Patients with severe renal impairment (creatinine clearance <30 mL/min);
②Patients with active major bleeding;
③Patients with bacterial endocarditis;
④Patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the ⑤presence of fondaparinux sodium;
⑥Patients with body weight <50 kg (VTE prophylaxis only);
⑦Patients with a history of severe hypersensitivity reactions to fondaparinux sodium (e.g., angioedema, anaphylactoid/anaphylactic reaction)