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Heparin Pregnancy and Breastfeeding Warnings

Heparin is also known as: Heparin Sodium

Heparin Pregnancy Warnings

Early studies evaluating the safety and efficacy of heparin in pregnancy suggested heparin offered no advantage over other anticoagulants. However, these studies failed to recognize maternal comorbid conditions as possible risk factors for adverse pregnancy outcomes. Exclusion of these cases resulted in more favorable outcomes in the heparin treated patients. In a retrospective cohort study of 100 pregnancies in 77 women treated with heparin, the rates of prematurity, spontaneous abortions, stillbirths, neonatal deaths, as well as congenital abnormalities were not significantly different than those in the normal population. In addition, there was no evidence of increased risk of maternal complications such as bleeding with heparin when compared to the normal population. A medical literature review found similar results. When pregnancies associated with comorbid conditions as independent risk factors and pregnancies complicated by prematurity were excluded, outcomes in heparin treated pregnancies were not significantly different from the normal population. Several studies have evaluated the risk of osteoporosis in women treated with long-term heparin therapy. Symptomatic osteoporosis is uncommon, but reductions in bone density are well documented. The clinical significance of this remains to be determined. Neonatal osteopenia has not been noted. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages greater than 99 mg/kg/day in neonates and low-birthweight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

Heparin has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted and there are no controlled data in human pregnancy. It does not cross the placenta due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered the anticoagulant of choice during pregnancy, although anticoagulation and maternal disease state may pose a risk to both the mother and fetus. Heparin should be given during pregnancy only when need has been clearly established. Do not administer heparin, preserved with benzyl alcohol to pregnant women. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. Heparin, preservative free, when indicated, should be used in these populations.

See references

Heparin Breastfeeding Warnings

Heparin is not excreted into human milk due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered compatible with breast-feeding. Do not administer heparin, preserved with benzyl alcohol to nursing mothers. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. Heparin, preservative free, when indicated, should be used in these populations.

Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages greater than 99 mg/kg/day in neonates and low-birthweight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

See references

References for pregnancy information

  1. "Product Information. Heparin Sodium (heparin)." Lilly, Eli and Company, Indianapolis, IN.
  2. Nageotte MP, Freeman RK, Garite TJ, Block RA "Anticoagulation in pregnancy." Am J Obstet Gynecol 141 (1981): 472-3
  3. Masamoto H, Toma T, Sakumoto K, Kanazawa K "Clearance of antiphospholipid antibodies in pregnancies treated with heparin - Reply." Obstet Gynecol 98 (2001): 162
  4. Bergqvist A, Bergqvist D, Hallbook T "Deep vein thrombosis during pregnancy." Acta Obstet Gynecol Scand 62 (1983): 443-8
  5. Chan WS, Anand S, Ginsberg JS "Anticoagulation of pregnant women with mechanical heart valves - A systematic review of the literature." Arch Intern Med 160 (2000): 191-6
  6. Aarskog D, Aksnes L, Markestad T, Ulstein M, Sagen N "Heparin-induced inhibition of 1,25-dihydroxyvitamin D formation." Am J Obstet Gynecol 148 (1984): 1141-2
  7. Fausett MB, Vogtlander M, Lee RM, Esplin MS, Branch DW, Rodgers GM, Silver RM "Heparin-induced thrombocytopenia is rare in pregnancy." Am J Obstet Gynecol 185 (2001): 148-52
  8. Flessa HC, Kapstrom AB, Glueck HI, Will JJ "Placental transport of heparin." Am J Obstet Gynecol 93 (1965): 570-3
  9. 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
  10. Hall JG, Pauli RM, Wilson KM "Maternal and fetal sequelae of anticoagulation during pregnancy." Am J Med 68 (1980): 122-40
  11. Brancazio LR, Roperti KA, Stierer R, Laifer SA "Pharmacokinetics and pharmacodynamics of subcutaneous heparin during the early third trimester of pregnancy." Am J Obstet Gynecol 173 (1995): 1240-5
  12. Toglia MR, Weg JG "Venous thromboembolism during pregnancy." N Engl J Med 335 (1996): 108-14
  13. McIntyre JA, Wagenknecht DR, Faulk WP "Clearance of antiphospholipid antibodies in pregnancies treated with heparin." Obstet Gynecol 98 (2001): 162
  14. Ginsburg JS, Hirsh J, Turner DC, Levine MN, Burrows R "Risks to the fetus of anticoagulant therapy during pregnancy." Thromb Haemost 61 (1989): 197-203
  15. Howell R, Fidler J, Letsky E, De Swiet M "The risks of antenatal subcutaneous heparin prophylaxis: a controlled trial." Br J Obstet Gynaecol 90 (1983): 1124-8
  16. Ginsburg JS, Kowalchuk G, Hirsh J, Brill-Edwards P, Burrows R "Heparin therapy during pregnancy." Arch Intern Med 149 (1989): 2233-6
  17. Barbour LA, Kick SD, Steiner JF, Loverde ME, Heddleston LN, Lear JL, Baron AE, Barton PL "A prospective study of heparin-induced osteoporosis in pregnancy using bone densitometry." Am J Obstet Gynecol 170 (1994): 862-9
  18. Ginsberg JS, Hirsh J "Use of antithrombotic agents during pregnancy." Chest 108 Suppl (1995): s305-11
  19. Barbour LA, Smith JM, Marlar RA "Heparin levels to guide thromboembolism prophylaxis during pregnancy." Am J Obstet Gynecol 173 (1995): 1869-73
  20. Ginsberg JS, Barron WM "Pregnancy and prosthetic heart valves." Lancet 344 (1994): 1170-2
  21. de Swiet M, Ward PD, Fidler J, Horsman A, Katz D, Letsky E, Peacock M, Wise PH "Prolonged heparin therapy in pregnancy causes bone demineralization." Br J Obstet Gynaecol 90 (1983): 1129-34
  22. Lecuru F, Desnos M, Taurelle R "Anticoagulant therapy in pregnancy - report of 54 cases." Acta Obstet Gynecol Scand 75 (1996): 217-21

References for breastfeeding information

  1. "Product Information. Heparin Sodium (heparin)." Lilly, Eli and Company, Indianapolis, IN.
  2. Ginsberg JS, Hirsh J "Use of antithrombotic agents during pregnancy." Chest 108 Suppl (1995): s305-11

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