Levomilnacipran Pregnancy and Breastfeeding Warnings

Levomilnacipran is also known as: Fetzima

Levomilnacipran Pregnancy Warnings

FDA pregnancy category: C Use of levomilnacipran is not recommended unless clearly needed. Women of childbearing potential should be encouraged to use adequate contraception.

No teratogenic effects were observed when levomilnacipran was administered to pregnant animals during the period of organogenesis at oral doses up to 8 and 16 times the maximum recommended human dose (MRHD). Fetal body weights were reduced, and skeletal ossification was delayed in animals at this dose. There are no controlled data in human pregnancy. A study of women with a history of major depression who were euthymic at the beginning of pregnancy, showed women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication. Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring hospitalization, respiratory support, and tube feeding. Symptoms may include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Levomilnacipran Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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