Enoxaparin Pregnancy and Breastfeeding Warnings
Enoxaparin is also known as: Clexane, Clexane Forte, Lovenox, Lovenox HP
Enoxaparin Pregnancy Warnings
Animal studies conducted at subcutaneous doses up to 15 times the recommended human dose showed no evidence of teratogenic effects or fetotoxicity. There are no adequate and well-controlled studies in pregnant women. A retrospective study reviewed the records of 604 pregnant women who used enoxaparin and found 72 hemorrhagic events in 63 women, 14 cases of neonatal hemorrhage, and major congenital anomalies in live births occurring at rates similar to background rates. Enoxaparin does not cross the placenta and is not expected to result in fetal exposure. In addition, human data from a retrospective cohort study suggests that enoxaparin does not increase the risk of major developmental abnormalities. The use of enoxaparin for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. There have been postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves receiving enoxaparin for thromboprophylaxis. Premature infants have experienced "gasping syndrome" with large amounts of benzyl alcohol (99 to 405 mg/kg/day). Multidose vials of Lovenox (R) contain 15 mg benzyl alcohol per 1 mL as preservative. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
FDA pregnancy category: B Use enoxaparin only if clearly needed.
Enoxaparin Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.
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