| The following sections have been updated;
Section 4.6: Pregnancy, Breastfeeding & Fertility sub headings introduced, animal reproductive toxicity study data included and related advisory given, neonatal withdrawal symptoms provided
From:
Epidemiological data have suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) 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.
Reproduction studies in animals at high doses revealed no evidence of impaired fertility, reproductive performance or teratogenic effects in the offspring. Caution should be exercised when prescribing to pregnant women.
Isolated cases of withdrawal symptoms in the newborn child have been described after the use of fluvoxamine at the end of pregnancy.
Fluvoxamine is excreted via human milk in small quantities. Therefore, the drug should not be used by women who breast feed.
To:
Pregnancy
Epidemiological data have suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) 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.
Reproduction toxicity studies in animals revealed treatment related increases in embryotoxicity (embryofetal death, fetal eye abnormalities). The relevance to humans is unknown. The safety margin for reproductive toxicity is unknown (see section 5.3).
Faverin 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.
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 Faverin impairs male and female fertility. The safety margin for this effect was not identified. The relevance of these findings to humans is unknown (see section 5.3).
Faverin should not be used in patients attempting to conceive unless the clinical condition of the patient requires treatment with fluvoxamine.
Section 4.8
From :
General disorders and administration site conditions: drug withdrawal syndrome including drug withdrawal syndrome neonatal.
To:
General disorders and administration site conditions: drug withdrawal syndrome including drug withdrawal syndrome neonatal (see section 4.6 Fertility, Pregnancy and Lactation).
Section 5.3
From :
There is no evidence of carcinogenicity, mutagenicity or impairment of fertility with fluvoxamine.
Reproduction studies in animals at high doses revealed no evidence of impaired fertility, reproductive performance or teratogenic effects in the offspring.
The potential for abuse, tolerance and physical dependence has been studied in a non-human primate model. No evidence of dependency phenomena was found.
To:
There is no evidence of carcinogenicity or mutagenicity with fluvoxamine.
Reproductive toxicity studies in rats have shown that fluvoxamine impairs male and female fertility (reduced sperm counts, increased ovary weights and reduced fertility), and is embryotoxic (increased embryofetal death [resorptions], increased fetal eye abnormalities [folded retina], reduced fetal weights and delayed ossification). The effects on fetal weights and ossification are likely to be secondary to maternal toxicity (reduced maternal bodyweight and bodyweight gain). The safety margin for reproductive toxicity is unknown.
The potential for abuse, tolerance and physical dependence has been studied in a non-human primate model. No evidence of dependency phenomena was found.
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