Risk Summary

There are no available data on heparin sodium use in pregnant women to infor a drug associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproductive studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 40,000 USP units/24 hours infusion (see Data). Consider the benefits and risks of HEPARIN SODIUM INJECTION to a pregnant woman and possible risks to the fetus when prescribing HEPARIN SODIUM INJECTION to a pregnant woman.

If available, preservative-free HEPARIN SODIUM INJECTION is recommended when heparin therapy is needed during pregnancy. There are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see Use in Specific Populations (8.4)].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Data

Risk Summary

There is no information regarding the presence of heparin in human milk, the effects on the breastfed child, or the effects on milk production. Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPARIN SODIUM INJECTION and any potential adverse effects on the breastfed child from HEPARIN SODIUM INJECTION or from the underlying maternal condition. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant [see Use in Specific Populations (8.4)].

Benzyl Alcohol Toxicity

Use preservative-free HEPARIN SODIUM INJECTION in neonates and infants.

Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol as a preservative in infusion solutions. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

When prescribing HEPARIN SODIUM INJECTION in infants consider the combined daily metabolic load of benzyl alcohol from all sources including HEPARIN SODIUM INJECTION (HEPARIN SODIUM INJECTION contains 9.45 mg of benzyl alcohol) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.4)].