Is Plaquenil (hydroxychloroquine) safe for a lactating woman with no pre-existing medical conditions to use while breastfeeding?

Is Plaquenil Safe for Breastfeeding?

Yes, hydroxychloroquine (Plaquenil) is strongly recommended as compatible with breastfeeding and should be continued during lactation.

Primary Recommendation

The American College of Rheumatology strongly recommends treatment with hydroxychloroquine (HCQ) as compatible with breastfeeding. 1 This represents the highest level of recommendation from major rheumatology guidelines, indicating that the benefits clearly outweigh any theoretical risks.

The 2024 KDIGO guidelines for lupus nephritis explicitly state that hydroxychloroquine has limited transfer into breast milk and is considered safe with breastfeeding. 1 This consensus is echoed across multiple high-quality guidelines from 2020-2024, all converging on the same conclusion. 1

Evidence Supporting Safety

Drug Transfer and Infant Exposure

• Hydroxychloroquine is present in human milk at low levels, with no adverse reactions reported in breastfed infants according to FDA labeling. 2
• The amount of HCQ received by infants through lactation is very low, well below the threshold considered safe (relative infant dose <10%). 3, 4
• No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children exposed to hydroxychloroquine through breastmilk. 2

Clinical Experience

• More than 250 pregnancies and lactation exposures have been documented with no increase in adverse outcomes. 3, 4
• Prolonged clinical experience over decades supports the safety profile during breastfeeding. 2

Clinical Decision Algorithm

1. Continue HCQ during breastfeeding - This is the default recommendation for all breastfeeding mothers with rheumatic diseases requiring HCQ. 1

2. Maintain disease control - Discontinuing HCQ may precipitate disease flares, which pose greater risks to both mother and infant than continued medication use. 5, 4

3. Encourage breastfeeding - Women with rheumatic and musculoskeletal diseases should be encouraged to breastfeed if they desire and are able to do so, while maintaining lactation-compatible medications like HCQ. 1

4. No need to interrupt nursing - There is no requirement to "pump and dump" or delay breastfeeding when taking hydroxychloroquine. 2

Important Caveats

Do not discontinue HCQ at the onset of breastfeeding. Withdrawal of hydroxychloroquine can result in disease exacerbation, particularly in systemic lupus erythematosus, which could be detrimental to both mother and infant. 5, 4 The risk of untreated or increased disease activity far exceeds any theoretical medication risk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hydroxychloroquine, as stated in FDA labeling. 2 However, given the strong safety data, this consideration typically favors continuing both breastfeeding and HCQ therapy.

Contrast with Other Medications

Unlike medications that are strongly contraindicated during breastfeeding (cyclophosphamide, leflunomide, mycophenolate, thalidomide), hydroxychloroquine carries a strong recommendation FOR use during lactation. 1 This places it in the safest category of rheumatologic medications for breastfeeding mothers, alongside colchicine, sulfasalazine, and TNF inhibitors. 1