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.

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.

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