Apo-Warfarin

Apo-Warfarin Use In Pregnancy & Lactation

warfarin

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category X: Do not take Apo-Warfarin during pregnancy and do not become pregnant while taking it (see Contraindications). Apo-Warfarin is contraindicated in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal haemorrhage to the fetus in utero. Furthermore, there have been reports of birth malformations in children born to mothers who have been treated with warfarin during pregnancy.
Embryopathy characterized by nasal hypoplasia with or without stippled epiphyses (chondrodysplasia punctata) has been reported in pregnant women exposed to warfarin during the 1st trimester. Central nervous system abnormalities also have been reported, including dorsal midline dysplasia characterized by agenesis of the corpus callosum, Dandy-Walker malformation and midline cerebellar atrophy. Ventral midline dysplasia, characterized by optic atrophy and eye abnormalities have been observed. Mental retardation, blindness and other central nervous system abnormalities have been reported in association with 2nd and 3rd trimester exposure. Although rare, teratogenic reports following in utero exposure to warfarin include urinary tract anomalies eg, single kidney, asplenia, anencephaly, spina bifida, cranial nerve palsy, hydrocephalus, cardiac defects and congenital heart disease, polydactyly, deformities of toes, diaphragmatic hernia and corneal leukoma, cleft palate, cleft lip, schizencephaly and microcephaly.
Spontaneous abortion and stillbirth are known to occur and a higher risk of fetal mortality is associated with the use of warfarin. Low birth weight and growth retardation have also been reported.
Women of childbearing potential who are candidates for anticoagulant therapy should be carefully evaluated and the indications critically reviewed with the patient. If the patient becomes pregnant while taking Apo-Warfarin, she should be apprised of the potential risks to the fetus, and the possibility of termination of the pregnancy should be discussed in light of those risks.
Use in lactation: Based on very limited published data, warfarin has not been detected in the breast milk of mother treated with warfarin. The same limited published data reported that some breast fed infants, whose mothers were treated with warfarin, had prolonged prothrombin times although not as prolonged as their mothers. The decision to breast feed should be taken after careful consideration of the available alternatives. Women who are breast feeding and anticoagulated with warfarin should be very carefully monitored so that recommended PT/INR values are not exceeded. It is prudent to perform coagulation tests and to evaluate vitamin K status in infants at risk for bleeding tendencies before advising their mothers to breast feed. Effects in premature infants have not been evaluated.
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