Adverse Effects

Bleeding is the most serious adverse effect of danaparoid. However, serious bleeding is uncommon except in patients who are treated with very high doses of the drug (e.g., cardiac surgery using CPB), or in those who develop drug accumulation (renal failure), or who have additional hemostatic or vascular defects. In contrast, bleeding was not seen in the randomized trial in which HIT patients with venous or arterial thromboses received danaparoid plus warfarin (Chong et al., 2001). When CPB patients are excluded, the overview of major bleeding episodes in relation to danaparoid use shows a drop in frequency from 8.1% to 4.6% (Magnani and Gallus, 2006).

Recurrence of skin hypersensitivity reactions in patients with reactions to UFH or LMWHs have been reported with danaparoid, but these are rare (Magnani, 1993, Magnani and Gallus 2006) and there are reports of successful use of danaparoid in such patients (Grassegger et al., 2001; Harrison et al., 2001; de Saint-Blanquat et al., 2000; Taylor, 2001). Pre-treatment skin cross-reactivity testing often reveals positive results (Figarella et al., 2001; Grassegger et al., 2001; Harenberg et al., 1999), but this does not necessarily translate into clinical problems, since in some patients, the reactions have been observed to diminish with each danaparoid injection and disappear after a few days. In addition, iv treatment with danaparoid of patients with positive skin tests has also proved successful (Boehnke et al., 1996; Jappe et al., 2002; Bircher et al., 2006).

Osteoporosis (a significant complication of prolonged UFH treatment) was not reported in any danaparoid-treated patients in the compassionate-use program, including pregnant patients treated for more than 3 mo.

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