Milnacipran Pregnancy and Breastfeeding Warnings

Milnacipran is also known as: Savella

Milnacipran Pregnancy Warnings

Milnacipran has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of an increased incidence of dead fetuses in utero, a decrease in body weight and viability, and an increased incidence of the skeletal variation, extra single rib. There are no controlled data in human pregnancy. Milnacipran should only be given during pregnancy when benefits outweigh risks.

Neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine, or selective serotonin reuptake inhibitors late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of these classes of drugs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome. The effect of milnacipran on labor and delivery is unknown. The use of milnacipran during labor and delivery is not recommended. Animal studies have reported an apparent dose-related decrease in the fertility index at clinically relevant doses based on body surface area.

Milnacipran Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Yes Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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