Taking Lovenox While Pregnant

Pregnancy B Category

• Because of the ethical issues concerning clinical trials in pregnant women, Lovenox's effect on pregnant women and any potential maternal or fetal risk has not been evaluated in well-controlled clinical studies. Nonetheless, all FDA-approved medicines have a pregnancy category rating, and Lovenox is in pregnancy category B, which means that the medication did not demonstrate any fetal risk in animal models. However, these animal studies are not predictive of the medication's effect in pregnant women.

Post-Marketing Studies

• Based on Sanofi-Aventis' post-marketing reports of Lovenox use in pregnant women, the drug's manufacturer concludes that the medication "is not predicted to increase the risk of major developmental abnormalities" when used during pregnancy and recommends that the medication be used during pregnancy when the benefits outweigh the risks.

  Analysis of post-marketing reports of 604 women treated with enoxaparin during pregnancy showed hemorrhagic events, fetal death and congenital anomalies in live births. The most common side effect was hemorrhagic event, which occurred in 63 women and 14 newborns. Hemorrhage can occur at any site in the body and may lead to death of mother and/or fetus. In addition, congenital anomalies also have occurred in live births.

  Additionally, these post-marketing reports lack information concerning any underlying diseases these women may have had or the circumstances in which Lovenox was administered. As a result, any cause-and-effect conclusions between Lovenox and these fetal deaths cannot be drawn.

Considerations

• The underlying condition of thromboembolic disease itself increases the risk of maternal complications and fetal loss, regardless of the type of anticoagulant used. Moreover, all anticoagulant treatments increase the risk of bleeding in all patients, including pregnant women.

  As delivery approaches, a different shorter-acting anticoagulant is recommended. Also, there are no data on whether enoxaparin is excreted into human milk. As a result, nursing mothers should seek the recommendation of healthcare providers.

Risk Factors

• Lovenox treatment may cause additional pregnancy complications in the presence of other preexisting conditions, in addition to thrombosis. Pregnant women with prosthetic heart valves have a higher rate of fetal loss from stillbirth, spontaneous abortion and premature delivery.

Warning

• Because Lovenox is made from pig heparin, all patients, including those who are pregnant with an allergy or sensitivity reaction to the active ingredient enoxaparin sodium, heparin or pork products should not use this anti-coagulant. Enoxaparin may contain a benzyl alcohol preservative, which also can harm the fetus.

  In addition, those with active major bleeding should not use Lovenox. Common side effects include mild reactions or irritation at the injection site, pain and other skin irritations.