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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.

See references

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.

See references

References for pregnancy information

  1. Melissari E, Parker CJ, Wilson NV, Monte G, Kanthou C, Pemberton KD, Nicolaides KH, Barrett JJ, Kakkar VV "Use of low molecular weight heparin in pregnancy." Thromb Haemost 68 (1992): 652-6
  2. Forestier F, Sole Y, Aiach M, Alhenc Gelas M, Daffos F "Absence of transplacental passage of fragmin (Kabi) during the second and the third trimesters of pregnancy ." Thromb Haemost 67 (1992): 180-1
  3. Rowan JA, McCowan LM, Raudkivi PJ, North RA "Enoxaparin treatment in women with mechanical heart valves during pregnancy." Am J Obstet Gynecol 185 (2001): 633-7
  4. Rasmussen C, Wadt J, Jacobsen B "Thromboembolic prophylaxis with low molecular weight heparin during pregnancy." Int J Gynaecol Obstet 47 (1994): 121-5
  5. Casele HL, Laifer SA, Woelkers DA, Venkataramanan R "Changes in the pharmacokinetics of the low-molecular-weight heparin enoxaparin sodium during pregnancy." Am J Obstet Gynecol 181 (1999): 1113-7
  6. Casele H, Haney EI, James A, Rosene-Montella K, Carson M "Bone density changes in women who receive thromboprophylaxis in pregnancy." Am J Obstet Gynecol 195 (2006): 1109-13
  7. Harenberg J, Schneider D, Heilmann L, Wolf H "Lack of anti-factor xa activity in umbilical cord vein samples after subcutaneous administration of heparin or low molecular mass heparin in pregnant women." Haemostasis 23 (1993): 314-20
  8. Ellison J, Thomson AJ, Walker ID, Greer IA "Use of enoxaparin in a pregnant woman with a mechanical heart valve prosthesis." Br J Obstet Gynaecol 108 (2001): 757-9
  9. Omri A, Delaloye JF, Andersen H, Bachmann F "Low molecular weight heparin Novo (LHN-1) does not cross the placenta during the second trimester of pregnancy." Thromb Haemost 61 (1989): 55-6
  10. Laurent P, Dussarat GV, Bonal J, et al. "Low molecular weight heparins: a guide to their optimum use in pregnancy." Drugs 62 (2002): 463-77
  11. Forestier F, Daffos F, Capella-Pavlovsky M "Low molecular weight heparin (PK 10169) does not cross the placenta during the second trimester of pregnancy (study by direct fetal blood sampling under ultrasound)." Thromb Res 34 (1984): 557-60
  12. Ensom MHH, Stephenson MD "Low-molecular-weight heparins in pregnancy." Pharmacotherapy 19 (1999): 1013-25
  13. Hague WM, North RA, Gallus AS, et al. "Anticoagulation in pregnancy and the puerperium. A working group on behalf of the Obstetric Medicine Group of Australasia." Med J Aust 175 (2001): 258-63
  14. Nelson-Piercy C, Letsky EA, de Swiet M "Low-molecular-weight heparin for obstetric thromboprophylaxis: experience of sixty-nine pregnancies in sixty-one women at high risk." Am J Obstet Gynecol 176 (1997): 1062-8
  15. "Product Information. Lovenox (enoxaparin)." Rhone-Poulenc Rorer, Collegeville, PA.
  16. "ACOG Committee Opinion: safety of Lovenox in pregnancy." Obstet Gynecol 100 (2002): 845-6

References for breastfeeding information

  1. "Product Information. Lovenox (enoxaparin)." Rhone-Poulenc Rorer, Collegeville, PA.

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