USA. FDA and Aventis Pharmaceuticals have strengthened the Warnings and Precautions sections of the prescribing information for enoxaparin sodium (Lovenox) injection. Healthcare professionals are informed that the use of this injection is not recommended for thromboprophylaxis in patients with prosthetic heart valves. This warning follows reports of prosthetic heart valve thrombosis in patients who had received enoxaparin. Some of these patients were pregnant women in whom thrombosis led to maternal and foetal deaths. Pregnant women with prosthetic heart valves may be at higher risk for thromboembolism. A paragraph has been added to the ‘teratogenic effects’ subsection regarding reports of congenital anomalies including cerebral anomalies, limb anomalies, hypospadias, peripheral vascular malformation, fibrotic dysplasia and cardiac defect in infants born to women who received enoxaparin during pregnancy. The non-teratogenic effects subsection has also been revised to indicate that pregnant women receiving anti-coagulants, including enoxaparin, are at increased risk for bleeding; hemorrhage can occur at any site and may lead to death of mother and/or foetus. Pregnant women and women of child-bearing potential should be apprised of the hazard to the foetus and the mother if enoxaparin is administered during pregnancy.

Reference:

‘Dear Healthcare Professional’ letter by Aventis Pharmaceuticals, Feb 2002. Available from URL: http://www.fda.gov/medwatch/SAF/ETY/2002