There is no evidence as to drug safety in human pregnancy.
In New Zealand White rabbits high doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats. The relevance of these findings to humans has not been established. Data have shown that Flecainide crosses the placenta to the foetus in patients taking Flecainide during pregnancy.
Flecainide is excreted in human milk and appears in concentrations which reflect those in maternal blood.
The risk of adverse effects to the nursing infant is very small.
The benefit of TAMBOCOR during lactation should therefore be weighed against the possible effects on the child.