An analysis of clinical outcomes of 91 pregnancies in 83 women treated with danaparoid (Orgaran).
Danaparoid case reports of 91 pregnancies in 83 patients with a history of thrombophilia and/or intra-uterine growth retardation have been analysed. All had intolerance to the heparins including HIT and acute or past thromboses or a history of repeated pregnancy loss (RPL). Danaparoid was started in the first, second and third trimesters in 60.2%, 19.3% and 20.5% pregnancies respectively at a dosing intensity of 1000 to 7500 U/day. Subcutaneous and/or intravenous administration was continued for a median 105 days (range 1-252) during pregnancy and 7 days (range 2 to 56) post-partum. The live birth rate was 90.4% (75/81) and danaparoid was restarted after 37 deliveries. Maternal adverse events in 46.2% of the pregnancies included 2 post cesarean deaths (a failed post-operative resuscitation and a major bleed in a patient refusing transfusion), 3 non-fatal major bleeds (associated with cesarean section and faulty placental implantation), 3 thrombo-embolic events unresponsive to danaparoid dose increase and 10 recurrent rashes. Seven early miscarriages, 1 therapeutic termination and 1 neonatal death occurred. In 13 reports a maternal, but no fetal, adverse event was attributed to danaparoid. Anti-Xa activity levels in maternal plasma were between 0.1 and 1.2 U/mL, absent from 6 fetal cord blood samples and 0 - 0.07 U/mL in the 5 maternal breast milk samples tested.


CONCLUSIONS
The successful birth rate and adverse event profile indicates that danaparoid can be an effective and safe alternative anti-thrombotic in pregnancies complicated by HIT or intolerance or resistance to (LMW)heparins.
Magnani
H N
HN
harry.magnani@hetnet.nl
D000022:Abortion, Spontaneous / Q000139:chemically induced / Q000188:drug therapy; D002809:Chondroitin Sulfates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003871:Dermatan Sulfate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D005076:Exanthema / Q000139:chemically induced / Q000188:drug therapy; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000188:drug therapy; D006493:Heparin / Q000009:adverse effects* / Q000627:therapeutic use; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use; D006497:Heparan Sulfate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D011247:Pregnancy; D012106:Research; D013927:Thrombosis / Q000139:chemically induced / Q000188:drug therapy; D016896:Treatment Outcome
D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D006493:Heparin; D006495:Heparin, Low-Molecular-Weight; D006497:Heparan Sulfate; C035838:danaparoid