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Milnacipran Pregnancy and Breastfeeding Warnings

Milnacipran is also known as: Savella

Milnacipran Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

Animal studies have revealed evidence of minor skeletal variation, embryo fetal, and perinatal lethality. There are no adequate or well-controlled studies in pregnant women. Neonates exposed to SSRIs and SNRIs late in the third trimester have uncommonly reported clinical findings including 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 SSRIs and SNRIs, or possibly a drug discontinuation syndrome. In some cases, the clinical picture is consistent with serotonin syndrome. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Healthcare providers are advised to recommend that pregnant patients taking Savella(R) enroll in the pregnancy registry. Enrolment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email at Data forms may also be downloaded from the registry website at US 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.

Milnacipran Breastfeeding Warnings

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

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