Sclerosing Agent
PREGNANCY RECOMMENDATION: Limited Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
The human pregnancy experience with polidocanol is limited. In animals, polidocanol was associated with both maternal and fetal toxicity in one species, but there was no evidence of an increase in structural abnormalities. The absence of human pregnancy experience prevents a better assessment of the risk to the embryo–fetus.
FETAL RISK SUMMARY
Polidocanol is given IV. It is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1–3 mm in diameter) in the lower extremities. Polidocanol causes local endothelial damage and occlusion of the varicose vein. In four patients, the mean half-life was 1.5 hours (1).
Reproduction studies have been conducted in rats and rabbits. No teratogenic or fetal toxic effects were noted in rats given IV doses up to the maximum human dose based on BSA (MHD) during gestation days 6–17. Polidocanol did not affect the ability of rats to deliver and rear pups when IV doses up to the MHD were given from gestation day 17 to postpartum day 21. In rabbits, IV doses up to the MHD during gestation days 6–20 caused maternal and fetal toxicity, including lower fetal weights and reduced fetal survival, but not skeletal or visceral abnormalities. No adverse maternal or fetal effects in rabbits were observed with a dose one-fifth the MHD (1).
Carcinogenicity studies have not been conducted with polidocanol. The drug was not genotoxic in multiple assays, but it induced numerical chromosomal aberrations in cultured newborn Chinese hamster lung fibroblasts. No effect on reproductive performance was observed in rats given intermittent IV doses equivalent to the MHD (1).
It is not known if polidocanol crosses the human placenta. The molecular weight (about 600) suggests that the drug will cross, but the short elimination half-life may limit the embryo–fetal exposure. Low systemic blood levels have been noted in some patients treated for spider or reticular veins (1). This might result in very-low-level exposure of the embryo–fetus.
A 1991 case report described a woman who was treated for a variceal hemorrhage with endoscopic intravasal injection of polidocanol in mid-pregnancy (2). No adverse effects were observed in her infant. A 2008 case report involved 3rd trimester in utero treatment of two fetuses with polidocanol for congenital cystic adenomatoid malformation of the lung (3). No apparent treatment-related adverse effects were noted in the infants.
BREASTFEEDING SUMMARY
No reports describing the use of polidocanol during lactation have been located. The low-level systemic blood levels and the molecular weight (about 600) suggest that the drug may be excreted into human milk. The effects of this exposure on a nursing infant are unknown but most likely lack clinical significance.
References
1.Product information. Asclera. Merz Aesthetics, 2011.
2.Potzi R, Ferenci P, Gangl A. Endoscopic sclerotherapy of esophageal varices during pregnancy—a case report. Z Gastroenterol 1991;29:246–7.
3.Bermudez C, Perez-Wulff J, Arcadipane M, Bufalino G, Gomez L, Flores L, Sosa C, Bornick PW, Kontopoulus E, Quintero RA. Percutaneous fetal sclerotherapy for congenital cystic adenomatoid malformation of the lung. Fetal Diagn Ther 2008;24:237–40.