Cymbalta Use In Pregnancy & Lactation



Eli Lilly


Full Prescribing Info
Use In Pregnancy & Lactation
Fertility: Cymbalta had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Pregnancy: There are no adequate data on the use of Cymbalta in pregnant women. Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of Cymbalta lower than the maximum clinical exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The potential risk for humans is unknown.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN to SNRIs treatment, this potential risk cannot be ruled out with Cymbalta taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).
As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate after maternal Cymbalta use near term. Discontinuation symptoms seen with Cymbalta may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. The majority of cases have occurred either at birth or within a few days of birth.
Cymbalta should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Lactation: Cymbalta is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children. The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see Pharmacology: Pharmacokinetics under Actions). As the safety of Cymbalta in infants is not known, the use of Cymbalta while breast-feeding is not recommended.
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