Ferric Carboxymaltose in Pregnancy
Ferric carboxymaltose can be used safely and effectively in the second and third trimesters of pregnancy for iron deficiency anemia when oral iron is inadequate, but resuscitation facilities must be available during administration due to the risk of severe hypersensitivity reactions that can cause fetal bradycardia. 1
Safety Profile and Critical Precautions
The FDA label explicitly warns that severe hypersensitivity reactions, including circulatory failure and shock, may occur with parenteral iron products and can cause fetal bradycardia, especially during the second and third trimester 1. This is the most serious concern and mandates:
- Resuscitation facilities must be immediately available when administering intravenous iron 2, 3
- Monitor for adverse effects for at least 30 minutes following IV administration 3
- Fetal heart rate monitoring should be performed during infusion 4, 5
Evidence for Efficacy
Multiple observational studies demonstrate consistent efficacy:
- In a prospective study of 863 pregnant women, ferric carboxymaltose significantly increased hemoglobin in all severity categories of anemia at 3 and 6 weeks post-infusion (p < 0.01), with no serious adverse events 6
- A retrospective case-control study of 128 patients showed median hemoglobin increased from 8.4 g/dL to 10.7 g/dL with no treatment-related adverse events 7
- Comparative data shows ferric carboxymaltose has a mean hemoglobin rise of 15.4 g/L versus 11.7 g/L for iron sucrose, with similar safety profiles 5
When to Use Ferric Carboxymaltose
Appropriate indications include: 3, 6
- Documented iron deficiency with unsatisfactory response to oral iron
- Intolerance to oral iron supplementation
- Gastrointestinal disorders aggravated by oral iron
- Need for rapid hemoglobin reconstitution in second or third trimester
Administration Protocol
- Maximum single dose is 1000 mg of iron, administered over minimum 15 minutes 3
- Median gestational age at treatment in studies was 34-35 weeks 4, 7
- Total correction dose up to 1500 mg can be administered 8
Adverse Effects Profile
Minor side effects occur in 11-20% of patients and are typically mild 4, 6:
- Local skin irritation, nausea, headache 6
- Rash, urticaria 1
- No serious adverse events reported in pregnancy studies 7, 6, 8
Important caveat: Hypophosphataemia occurs in 58% of patients receiving ferric carboxymaltose (versus 4% with iron derisomaltose), though most cases are asymptomatic and resolve without intervention 9. The clinical significance in pregnancy has not been established.
Alternative Considerations
The CDC and USPSTF guidelines focus on oral iron and do not specifically address intravenous formulations 2. Iron sucrose has more established pregnancy data and should be considered when clinically appropriate, though it requires multiple infusions (maximum 200 mg per dose) versus the convenience of single or double dosing with ferric carboxymaltose 9, 2.
Fetal and Neonatal Outcomes
Published data from randomized controlled trials, prospective observational studies, and retrospective studies have not reported an association between ferric carboxymaltose and major birth defects or miscarriage 1. No adverse fetal or neonatal outcomes were observed in the largest prospective study of 863 women 6.