Is fluvoxamine (Luvox) safe to use during pregnancy?

Fluvoxamine Use During Pregnancy

Fluvoxamine can be continued during pregnancy when clinically necessary, as it does not appear to increase the risk of major congenital malformations, though neonates should be monitored for transient withdrawal or adaptation symptoms in the first 1-2 weeks after birth. 1

Safety Profile During Pregnancy

Teratogenic Risk

• Current data does not indicate a specific teratogenic risk with fluvoxamine use during pregnancy. 2
• The available evidence, while limited compared to other SSRIs, suggests fluvoxamine can be used when the clinical benefit justifies potential risks. 2
• The FDA label classifies fluvoxamine as Pregnancy Category C, noting that animal studies at doses up to 2 times the maximum human dose showed no fetal malformations, though some pup mortality and weight effects were observed at higher doses. 3

Neonatal Adaptation Syndrome

• Third-trimester exposure to fluvoxamine and other SSRIs can cause a constellation of transient neonatal symptoms including continuous crying, irritability, jitteriness, tremors, hypertonia, tachypnea, feeding difficulty, sleep disturbance, hypoglycemia, and seizures. 1
• These symptoms typically begin within hours to days after birth and resolve within 1-2 weeks without long-term sequelae. 1
• The mechanism remains debated between serotonin syndrome versus SSRI withdrawal, but the clinical presentation is consistent and self-limiting. 1

Long-Term Neurodevelopmental Outcomes

• Several reviews have not identified adverse neurodevelopmental outcomes among infants born to women treated with SSRIs during pregnancy. 1
• This reassuring finding supports continuation of treatment when clinically indicated. 1

Clinical Management Algorithm

Decision to Continue or Discontinue

• SSRI treatment should be continued during pregnancy at the lowest effective dose, because withdrawal of medication may have harmful effects on the mother-infant dyad. 1
• The risk of untreated maternal depression—including potential suicide, infanticide, and negative impact on child emotional development—must be weighed against medication risks. 4
• Abrupt discontinuation carries its own risks and should be avoided. 4

Monitoring Requirements

• Arrange for early neonatal follow-up after initial hospital discharge, as infants are at risk for manifesting clinical signs of drug toxicity or withdrawal over the first week of life. 1
• Monitor neonates specifically for: respiratory distress, feeding difficulties, irritability, tremors, hypertonia, temperature instability, and hypoglycemia. 1, 3
• In severely affected infants, a short-term course of chlorpromazine has provided measurable symptom relief. 1

Dosing Considerations

• Use the lowest effective dose to maintain maternal mental health. 1
• No specific dose adjustments are mandated by pregnancy itself, but clinical optimization is appropriate. 3

Breastfeeding Considerations

Milk Excretion Profile

• Fluvoxamine is minimally excreted in human milk and provides the infant <10% of the maternal daily dose (normalized for weight). 1
• This favorable profile makes fluvoxamine one of the preferred SSRIs during lactation. 1
• However, 33% of reported paired infant-to-maternal plasma concentration ratios for fluvoxamine are >0.10, which is higher than some other SSRIs like paroxetine. 1

Clinical Recommendations

• A mother on fluvoxamine who desires to nurse should be counseled about the risks and benefits, but breastfeeding can generally be supported. 1
• Monitor breastfed infants for diminished suck, sleep disturbances, and decreased growth, though these are uncommon. 1
• Fluvoxamine can be used during breastfeeding based on current data. 2

Common Pitfalls to Avoid

• Do not discontinue fluvoxamine abruptly upon discovering pregnancy—this increases risk of maternal relapse and withdrawal symptoms. 1, 4
• Do not assume neonatal symptoms represent a serious long-term problem—most adaptation symptoms are self-limiting and resolve within 1-2 weeks. 1
• Do not fail to arrange early postnatal follow-up—symptoms may not be apparent at initial hospital discharge but can develop over the first week. 1
• Do not avoid live vaccines in the newborn unless the mother received anti-TNF medications after 20 weeks—this caveat does not apply to SSRIs. 1