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Enoxaparin Pregnancy and Breastfeeding Warnings

Enoxaparin is also known as: Clexane, Clexane Forte, Lovenox, Lovenox HP

Enoxaparin Pregnancy Warnings

Transplacental passage of enoxaparin was studied in five women prior to undergoing elective abortion in week 23 of pregnancy because of fetal anomalies. Three hours following subcutaneous administration of 7,500 units of enoxaparin, fetal blood samples were drawn and analyzed for anti-Xa and anti-IIa activity. No changes were noted in samples when compared with frozen pooled samples obtained from normal fetuses at 23 weeks gestation. Additional studies have evaluated the heparin activity of low molecular weight heparin (LMWH) in pregnant women who have gone to term. Some patients had begun treatment with LMWH as early as the 14th week of gestation. At the time of delivery, no anti-factor Xa activity was demonstrated in any infant. The results of a small, retrospective analysis of 34 pregnant women treated daily with 40 mg of enoxaparin for a median of 91 days, have been reported. In this small group of patients, the results appeared to indicate the use of enoxaparin for thromboembolic treatment or prophylaxis during pregnancy, may be a treatment option. Excessive bleeding was not reported, even for procedures such as amniocentesis, Cesarean sections, second trimester pregnancy termination, or epidural administration. Median gestational age at delivery was 39 weeks. One case of thrombosis occurred in a high risk patient receiving 20 mg per day of enoxaparin. There have been reports of congenital anomalies in infants born to women who received enoxaparin during pregnancy including cerebral anomalies, limb anomalies, hypospadias, peripheral vascular malformations, fibrotic dysplasia, and cardiac defect, and rarely, fetal death. A cause and effect relationship has not been established, nor has the incidence been shown to be higher than in the general population. There have been postmarketing reports of fetal death when pregnant women have received enoxaparin. A cause and effect relationship has not been established, nor has the incidence been shown to be higher than in the general population. In one case, placental hemorrhage and detachment were found in association with the fetal death. Maternal osteoporosis (2% incidence of 10% or greater bone loss in the femur) has been reported in pregnant women who received enoxaparin (68.4 mg/day) for thromboprophylaxis for approximately 27 weeks. The use of enoxaparin for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves given enoxaparin (1 mg/kg twice daily) to reduce the risk of thromboembolism, 2 of 8 women developed clots resulting in blockage of the valve and leading to maternal and fetal death. Although a causal relationship has not been established these deaths may have been due to therapeutic failure or inadequate anticoagulation. No patients in the heparin/warfarin group (0 of 4 women) died. There also have been isolated postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis. Women with mechanical prosthetic heart valves may be at higher risk for thromboembolism during pregnancy, and, when pregnant, have a higher rate of fetal loss from stillbirth, spontaneous abortion and premature delivery. Therefore, frequent monitoring of peak and trough anti-Factor Xa levels, and adjusting of dosage may be needed.

Enoxaparin has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of teratogenicity. Safety and efficacy of low molecular weight heparins (LMWH) during pregnancy have been demonstrated. However, efficacy data for LMWH compared with unfractionated heparin are not available. Single doses, 2500 to 5000 anti-Xa units, of other LMWH during the second and third trimester of pregnancy did not result in fetal anti-Xa or antithrombin activity. The multi-dose formulation of enoxaparin preserved with benzyl alcohol should be used with caution in pregnancy, as benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature neonates. Enoxaparin does not cross the placenta. Enoxaparin is only recommended for use during pregnancy when benefit outweighs risk.

Enoxaparin Breastfeeding Warnings

There are no data on the excretion of enoxaparin into human milk. Because many drugs are excreted into human milk, caution should be used when enoxaparin is administered to nursing women.

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