Versant-XR Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C: There are no adequate or well-controlled studies in pregnant women. Felodipine should not be given during pregnancy.
Teratogenic Effects: In animal studies, pregnant rabbits given felodipine 0.46, 1.2, 2.3, and 4.6 mg/kg/day (0.8 to 8 times** the maximum recommended human dose on a mg/m² basis) showed digital anomalies consisting of reduction in size and degree of ossification of the terminal phalanges in the fetuses. The frequency and severity of the changes appeared dose related and were observed even at the lowest dose. These changes have been shown to occur with other members of the dihydropyridine class and are possibly a result of compromised uterine blood flow. Similar fetal anomalies were not observed in rats given felodipine.
In cynomolgus monkeys, no reduction in size of the terminal phalanges was reported, but an abnormal position of the distal phalanges was seen in about 40% of the fetuses.
Nonteratogenic Effects: A prolongation of parturition with difficult labor and an increased frequency of fetal and early postnatal deaths were observed in rats given felodipine 9.6 mg/kg/day (8 times** the maximum human dose on a mg/m² basis) and above.
** Based on patient weight of 50 kg.
(2.1 times the maximum human dose on a mg/m² basis). This effect occurred only in pregnant rabbits and regressed during lactation.
Significant enlargement of the mammary glands, in excess of the normal enlargement for pregnant rabbits, was observed with doses greater than or equal to 1.2 mg/kg/day.
Lactation: Felodipine has been detected in breast milk, but it is unknown whether it has harmful effects on the newborn. A decision should therefore be made whether to discontinue breastfeeding or to discontinue felodipine, taking into consideration the importance of the drug to the mother.