May 23 2022

Classification of the active ingredient enoxaparin


Risk level in pregnancy: This medicine is classified as Category B.

The use of enoxaparin for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been studied extensively and is pending a consensus among experts.

In a clinical study of pregnant women with mechanical heart valve prostheses (1 mg/kg/12 h) to reduce the risk of thromboembolism, 1 in 4 women had clots that led to the valve obstruction and led to maternal and fetal death. Although no causal relationship has been established, these deaths could have been due to therapeutic failure or inadequate anticoagulation. None of the control group patients with heparin / warfarin died.

Have been published cases 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 also have a higher rate of stillbirth, spontaneous abortion and premature delivery. Therefore, may be necessary to frequently check the maximum levels and minimal anti-factor Xa, and the adjustment of the dose.

In a review of 600 retrospectively followed pregnancies in women exposed to enoxaparin, the incidence of congenital anomalies did not exceed what is expected in the general population.

Update 18.07.2009

Meaning of 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 OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.