Is Hydroxychloroquine safe while breastfeeding?

Effects on the breastfed infant

No adverse effects were reported in one 9-month-old breastfed infant whose mother was taking 310 mg hydroxychloroquine base daily for 6 weeks.[ 9 ] Five mothers took hydroxychloroquine 200 mg daily during pregnancy and breastfeeding, one for 30 months. Flash electroretinograms performed on the infants were normal.[ 1 ] Another group of investigators have reported numerous infants whose mother took hydroxychloroquine during pregnancy and were breastfed during maternal hydroxychloroquine use. An abstract reported 16 infants breastfed for 1 to 19 months and followed up at an average of 24 months (range 1 to 86 months) with no evidence of visual or hearing deficits.[ 14 ] In a letter they reported 8 breastfed infants followed up at 1, 6 and 12 months of age who had normal growth and development and who had thorough, normal eye examinations at 1 and 12 months of age.[ 15 ] In a case series, 13 mothers taking hydroxychloroquine sulfate 200 mg daily breastfed their infants for an average of 2.8 months (range 1 to 6 months). None had evidence of retinal, motor or growth abnormalities during 12 months of follow-up. The authors conclude that the benefits of breastfeeding outweigh the risk of hydroxychloroquine.[ 2 ] It appears that the 8 infants reported in the letter were included among the 13 infants in the case series, but it is unclear whether the 16 infants reported in the abstract were part of the case series. Thirty-three women who had been taking hydroxychloroquine for at least one year and exclusively breastfeeding had hydroxychloroquine milk levels determined over a 12-hour period. Two-thirds of the women were also taking a corticosteroid. Dosages ranged from 200 mg once every two days to 200 mg twice daily. Follow-up at 1 year of the infants did not find ocular toxicity or growth abnormalities.[ 3 ] In a cohort study, over a 10-year period 130 nursing mothers with a rheumatic disease took hydroxychloroquine during partial or exclusive breastfeeding. No mention was

Effects on milk supply

A study of 43 women with systemic lupus erythematosus and their 57 pregnancies found that the use of hydroxychloroquine to treat the disease was associated with an increased duration of breastfeeding. Among mothers taking hydroxychloroquine, 88% breastfed for more than 6 months compared to 54% of women who did not take hydroxychloroquine.[ 20 ]

Levels in milk

Hydroxychloroquine is usually available as the sulfate salt with hydroxychloroquine constituting about 75% of the labeled dose of hydroxychloroquine sulfate. It has a half-life of over a month. Some studies have not been clear about the salt form and dosage of the products being taken and others have sampled milk after only a few doses before steady state was reached. These flaws make interpretation of some of the data difficult. Maternal Levels . In a patient beginning therapy with 200 mg of hydroxychloroquine (salt unspecified) twice daily, the highest milk level detected was 10.6 mcg/L from 3 to 12 hours after the fourth dose. After the first 48 hours of treatment with a total dosage of 800 mg, a total of 3.2 mcg was excreted into her breastmilk. This amounted to 0.0003% of the mother s total dosage.[ 8 ] However, it is unlikely that steady state had been reached at this time. A woman who had been breastfeeding for 9 months began taking hydroxychloroquine sulfate 400 mg (equivalent to 310 mg hydroxychloroquine base) nightly. After 6 weeks of this regimen, steady-state milk levels were 1.46, 1.09, 1.09 and 0.85 mg/L at 2, 9.5, 14 after one dose and 17.7 hours after a dose on the next day. The authors estimated that the infant would receive 0.11 mg/kg daily or about 2% of the mother s weight-adjusted dosage.[ 9 ] Two women who had taken hydroxychloroquine 200 mg (probably sulfate equivalent to 150 mg of base) once or twice daily (the report is unclear) before and during pregnancy had milk levels measured after delivery. Hydroxychloroquine levels in the two mothers were 344 and 1424 mcg/L at unspecified times after a dose. The authors estimated an infant intake of 0.06 and 0.2 mg/kg daily in the two infants.[ 10 ] These authors also reported two other women who had milk hydroxychloroquine levels of 1131 and 1392 mcg/L at unreported times after unspecified doses (presumably 200 to 400 mg daily). The authors estimated that these two infants would receive no more than

Alternatives LactMed lists

• Etanercept
• Gold Sodium Thiomalate
• Infliximab
• Methotrexate
• Penicillamine
• Sulfasalazine