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Dalteparin Pregnancy and Breastfeeding Warnings

Dalteparin is also known as: Fragmin

Dalteparin Pregnancy Warnings

One study has reported the effects of dalteparin at dosages of 2,500 to 10,000 intl units daily for 9 to 26 weeks in 24 pregnant women at risk for thromboembolic events. Dosages were adjusted to maintain a dalteparin plasma concentration of 0.20 to 0.50 anti-Xa units/mL. Complications included 3 spontaneous abortions (2 of these women later gave birth to healthy babies while being treated with dalteparin), 2 cases of preeclampsia and 1 patient with ecchymoses at the abdominal injection site. No anti-Xa activity was present in the cord blood of 12 babies who had samples taken at birth, although 9 of the 12 mothers did show anti-Xa activity at the time of delivery. All babies delivered were healthy and without abnormalities, and none showed signs of altered coagulation.

Dalteparin has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. Safety and efficacy of low molecular weight heparins (LMWH) during pregnancy have been demonstrated. However, efficacy data comparing LMWH with unfractionated heparin are not available. Single doses, 2500 to 5000 anti-Xa units, of LMWH during the second and third trimester of pregnancy did not result in fetal anti-Xa or antithrombin activity. Multiple-dose vials of dalteparin contain benzyl alcohol which cannot be metabolized by the fetus and should be avoided during pregnancy. Dalteparin should be given during pregnancy only when need has been clearly established.

Dalteparin Breastfeeding Warnings

Dalteparin has been found to be excreted into human milk in small quantities. The manufacturer recommends that caution be used when administering dalteparin to nursing women.

In a study of 15 lactating mothers who had experienced recent Cesarean section, dalteparin was found to be present in minute quantities in breast milk. The researchers measured anti-Xa activity in the mother's plasma and in the expressed colostrum. The average activities of the samples were calculated and a milk-to-plasma ratio of <0.025 to 0.224 was obtained. Based on that data, the researchers determined that, at most, a nursing infant would be exposed to the equivalent of 5.4% of the maternal dose per kilogram of body weight. Since the exposure would be in the form of orally ingested milk containing dalteparin, the amount of dalteparin that would be expected to be absorbed and present in the plasma of the infant would be minimal. Therefore, the authors concluded that it would be highly unlikely that puerperal thromboprophylaxis with dalteparin would have any clinically relevant effect on the nursing infant.

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