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Sodium ferric gluconate complex Pregnancy and Breastfeeding Warnings

Sodium ferric gluconate complex is also known as: Ferrlecit, Nulecit

Sodium ferric gluconate complex Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B Comments: -There are no known adverse effects associated with fetal exposure to benzyl alcohol with maternal administration, however it can cause serious adverse events and death when given intravenously to neonates and infants.

Animal studies showed no evidence of harm to the fetus at up to 4 times the human dose. There are no controlled data in human pregnancy. US 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.

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Sodium ferric gluconate complex Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Benzyl alcohol in maternal serum is likely to cross into milk and be absorbed by the nursing infant. -Benzyl alcohol has been associated with serious adverse events and death in pediatric patients. -Gasping syndrome (central nervous system depression, metabolic acidosis, gasping respirations, and high benzyl alcohol levels in blood and urine) has been associated with benzyl alcohol doses over 99 mg/kg/day in neonates and low birth weight infants. -Although the amount of benzyl alcohol in normal therapeutic doses of this drug are lower than those associated with gasping syndrome, the minimum amount of benzyl alcohol at which toxicity occurs is unknown. -Consider the combined load of benzyl alcohol from all sources.

See references

References for pregnancy information

  1. "Product Information. Ferrlecit (sodium ferric gluconate complex)." sanofi-aventis, Bridgewater, NJ.

References for breastfeeding information

  1. "Product Information. Ferrlecit (sodium ferric gluconate complex)." sanofi-aventis, Bridgewater, NJ.

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