Propafenone Pregnancy and Breastfeeding Warnings

Propafenone is also known as: Rythmol, Rythmol SR

Propafenone Pregnancy Warnings

FDA pregnancy category: C Use propafenone only if clearly needed and benefit outweighs potential risk.

Animal studies have revealed evidence of embryotoxicity, but no teratogenicity after administration of dosages 10 to 40 times the maximum recommended human dose (on a per kg basis). There are no controlled data in human pregnancy. Limited data indicate that propafenone has been administered during the third trimester of pregnancy without adverse maternal or fetal effects. Propafenone should be given during pregnancy only when benefit outweighs risk. Both propafenone and 5-hydroxypropafenone cross the placenta. Two cases describing the use of propafenone 900 mg daily during pregnancy are reported. The placental blood or umbilical cord to maternal plasma drug concentration ratios were 0.1 to 0.3 for propafenone and 0.4 to 0.5 for 5-hydroxypropafenone in each case. Unbound drug and metabolite freely cross the placenta, with cord and maternal plasma concentrations approximately equal. No harmful effects on the human fetus have been reported during the third trimester of pregnancy, but data are limited. Data are unavailable regarding the use of propafenone earlier in pregnancy. Increased maternal alpha-1-acid glycoprotein serum levels are expected during and after pregnancy. This may result in increased plasma protein binding of propafenone, although the clinical importance of this is not known.

Propafenone Breastfeeding Warnings

In one case, 3 days following propafenone dosing the milk to maternal plasma concentration ratios were 0.15 and 0.55 for propafenone and 5-hydroxypropafenone, respectively. An intake of 150 mL/kg/day of maternal milk would result in a nursing infant exposure of 16 to 24 mcg per day.

Use of propafenone is not recommended. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing woman are not known.

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