Faverin Use In Pregnancy & Lactation

Pregnancy: Epidemiological data have suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRI) in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.
Fluvoxamine should not be used during pregnancy unless the clinical condition of the woman requires treatment with fluvoxamine.
Isolated cases of withdrawal symptoms in the newborn child have been described after the use of fluvoxamine at the end of pregnancy. Some newborns experience feeding and/ or respiratory difficulties, seizures, temperature instability, hypoglycaemia, tremor, abnormal muscle tone, jitteriness, cyanosis, irritability, lethargy, somnolence, vomiting, difficulty in sleeping and constant crying after third trimester exposure to SSRIs and may require prolonged hospitalization.
Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI exposure within the month prior to birth.
Breastfeeding: Fluvoxamine is excreted via human milk in small quantities. Therefore, the drug should not be used by women who breast-feed.
Fertility: Reproductive toxicity studies in animals have shown that fluvoxamine impairs male and female fertility. The relevance of these findings to humans is unknown (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fluvoxamine should not be used in patients attempting to conceive unless the clinical condition of the patient requires treatment with fluvoxamine.