Duloxetine Pregnancy and Breastfeeding Warnings

Duloxetine is also known as: Cymbalta

Duloxetine Pregnancy Warnings

Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. If treating pregnant women with duloxetine during the third trimester, the physician may wish to consider tapering this drug. 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 effects have mostly occurred either at birth or within a few days of birth. 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. Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn. Data are not available for SNRIs. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Healthcare providers are encouraged to register patients by calling the Cymbal (R) Pregnancy Registry at 1-866-814-6975 or by visiting www.cymbaltapregnancyregistry.com. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Duloxetine Breastfeeding Warnings

Use is not recommended Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown. If used, the infant should be monitored for drowsiness, adequate weight gain, and developmental milestones, particularly younger, exclusively breastfed infants, and when using combinations of psychotropic drugs.

In lactating women receiving duloxetine 40 mg orally every 12 hours and 60 mg orally once a day the daily infant dose, on a mg per kg basis, is estimated at approximately 0.14% and 0.82% of the maternal dose, respectively. If the benefit is considered to outweigh the risk, no dosage adjustment is required as lactation does not influence duloxetine pharmacokinetics.

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