From the Guidelines
Fluvoxamine is generally considered safe during breastfeeding, as the benefits of treating maternal depression or anxiety typically outweigh the minimal risks to the breastfed infant. The amount of fluvoxamine that passes into breast milk is relatively small, with infants receiving approximately 0.5-2.7% of the maternal weight-adjusted dose 1. According to the guideline from the Association of Anaesthetists, a drug with a relative infant dose of less than 10% is considered the preferred option 1.
Key Considerations
- The relative infant dose of fluvoxamine is less than 10%, making it a preferred option for breastfeeding mothers 1.
- No significant adverse effects have been reported in breastfed infants whose mothers were taking fluvoxamine, and there have been no reports of developmental delays or abnormalities attributed to exposure through breast milk 1.
- As with any medication during breastfeeding, it's advisable to monitor the infant for unusual drowsiness, irritability, poor feeding, or changes in sleep patterns.
- The timing of medication can be adjusted to minimize infant exposure, typically by taking the dose immediately after breastfeeding or before the infant's longest sleep period.
- For mothers starting fluvoxamine while breastfeeding, beginning with a lower dose and gradually increasing it can help minimize any potential side effects for both mother and infant.
Recommendations
- Breastfeeding mothers can safely take fluvoxamine, but should be closely monitored by their healthcare provider.
- The infant should be monitored for any signs of adverse effects, such as unusual drowsiness or irritability.
- The mother's dose should be adjusted as needed to minimize infant exposure while maintaining therapeutic efficacy.
From the FDA Drug Label
As for many other drugs, fluvoxamine is secreted in human breast milk The decision of whether to discontinue nursing or to discontinue the drug should take into account the potential for serious adverse effects from exposure to fluvoxamine in the nursing infant as well as the potential benefits of Fluvoxamine Maleate Tablets therapy to the mother
The safety of fluvoxamine (Luvox) during breastfeeding is not established, and the decision to continue breastfeeding or discontinue the drug should be made considering the potential risks and benefits. Caution is advised due to the potential for serious adverse effects in the nursing infant. 2
From the Research
Safety of Fluvoxamine During Breastfeeding
- The safety of fluvoxamine during breastfeeding has been studied in several research papers 3, 4, 5, 6.
- A study published in 2001 found that infant serum fluvoxamine levels were too low to quantify, and no adverse events were reported in the infants 3.
- Another study from 2001 found that the relative dose to the infant is lowest for fluvoxamine and sertraline, and minimal excretion of fluvoxamine into breast milk was observed 4.
- A systematic review published in 2015 found that sertraline and paroxetine show a better neonatal safety profile during breastfeeding, but less data are available for fluvoxamine 5.
- A case series published in 2023 found that infant exposure to fluvoxamine through human milk is minimal, with relative infant doses ranging from 0.35 to 0.90% 6.
- In general, most commonly used drugs, including fluvoxamine, are relatively safe for breastfed babies, with the dose received via milk being generally small 7.
Key Findings
- Fluvoxamine is considered to have a low risk of adverse effects in breastfed infants 3, 4, 6.
- The relative dose to the infant is lowest for fluvoxamine and sertraline 4.
- Minimal excretion of fluvoxamine into breast milk has been observed 4, 6.
- Larger clinical and pharmacokinetic studies are warranted to assess the long-term safety of fluvoxamine during lactation 6.