Is Hydroxychloroquine (HCQ) contraindicated in pregnancy?

Hydroxychloroquine in Pregnancy: Safety and Recommendations

Hydroxychloroquine (HCQ) is not contraindicated in pregnancy and should be continued throughout pregnancy in patients with systemic lupus erythematosus (SLE) or other rheumatic diseases when clinically indicated. 1, 2

Safety Profile in Pregnancy

• The FDA pregnancy category for HCQ is C, but current evidence strongly supports its safety during pregnancy 1, 2
• According to the FDA label, prolonged clinical experience and available data from published studies have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes 2
• Multiple studies demonstrate HCQ's safety in pregnancy:
  • A study of 133 pregnancies in women treated with HCQ showed no difference in live birth rates (88% vs 84%) or congenital malformations compared to controls 3
  • No visual, hearing, growth, or developmental abnormalities were reported in children followed up to 108 months 3
  • HCQ crosses the placenta with cord blood levels similar to maternal levels, but no retinal toxicity, ototoxicity, cardiotoxicity, or developmental abnormalities have been observed in children exposed in utero 2

Benefits of HCQ in Pregnancy

• For SLE patients, HCQ during pregnancy:
  • Reduces disease flares 1, 4
  • Improves pregnancy outcomes 4
  • May allow for decreased prednisone dosing 5
• A randomized controlled study showed that SLE patients on HCQ had:
  • No flares during pregnancy compared to three flares in the placebo group
  • Lower disease activity scores
  • Higher delivery age and Apgar scores 5

Clinical Recommendations

• The 2020 American College of Rheumatology guidelines strongly recommend continuing HCQ during pregnancy if a patient is already taking it 1, 4
• For SLE patients not already on HCQ, starting it during pregnancy is conditionally recommended if there is no contraindication 1, 4
• Potential contraindications include allergy, adverse side effects, or intolerance 1, 4
• Regular monitoring during pregnancy should include:
  • Disease activity assessment at least once per trimester
  • Laboratory monitoring including complete blood count, urinalysis, and renal function parameters 4
• Ocular toxicity monitoring should continue during pregnancy (every 6-12 months) 1

Breastfeeding Considerations

• HCQ is present in human milk at low levels 2
• No adverse reactions have been reported in breastfed infants 2
• No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children exposed through breastmilk 2
• Breastfeeding is considered compatible with HCQ use 6

Potential Pitfalls and Caveats

• Discontinuing HCQ at the onset of pregnancy may trigger disease flares, which could be detrimental to both mother and fetus 7, 6
• The risks of untreated or increased disease activity from SLE in pregnancy (including preterm delivery, fetal loss, and preeclampsia) outweigh the theoretical risks of HCQ 2
• HCQ should be distinguished from chloroquine, which has a less favorable safety profile and more potential for cardiac disturbances 1

In conclusion, current evidence and guidelines strongly support continuing HCQ throughout pregnancy when clinically indicated, particularly for patients with SLE, as the benefits outweigh any theoretical risks.