Is there an increased risk of teratogenicity to the fetus after treatment with lansoprazole during

Fråga: Is there an increased risk of teratogenicity to the fetus after treatment with lansoprazole during pregnancy?

A woman now pregnant in about week 14 has been taking lansoprazole almost daily during the pregnancy for heartburn.

Sammanfattning: Available data on lansoprazole do not indicate that the drug is harmful to the fetus. However the data are insufficient to assess the safety of its use during pregnancy. Omeprazole, another proton pump inhibitor with every similar chemical structure is considered safe to use during pregnancy.

Svar: Lansoprazole is a proton pump inhibitor. There is limited experience of the use of lansoprazole in pregnant women and there are no studies where lansoprazole specifically has been investigated. A reproductive study in rats and rabbits did not show evidence of elevated risk of fetal malformations when the animals were exposed to doses 40 and 16 times the recommended human dose (1).

In the Swedish medical birth registry, there are 24 reports of lansoprazole exposure during pregnancy (2). Two of the children had some kind of malformation, but the number of reports is obviously too small to draw any conclusion.

Proton pump inhibitors as a group have not been shown to substantially increase the overall risk of fetal malformations (3). In a cohort study 51 women exposed to proton pump inhibitors (three to lansoprazole) around the time of conception or during pregnancy were compared with 13327 controls without exposure to any prescribed drug. The study did not show any substantially increased risk of fetal harm in pregnancies exposed to proton pump inhibitors (3).

In the Swedish medical birth registry there are 989 reports of proton pump inhibitor exposure during pregnancy and no increase of the total number of fetal malformations (2).

Omeprazole is a proton inhibitor, which has a chemical structure that is very similar to lansoprazole (4). The question whether omeprazole is harmful to the human fetus has previously been reviewed in Drugline (5). The conclusion is that omeprazole can be considered safe to use during pregnancy. 1 Schardein JL, Furuhashi T, Ooshima Y: Reproductive and developmental toxicity studies of lansoprazole (AG-1749) in rats and rabbits. Jpn Pharmacol Ther 1990; 10: 119-129 2 Swedish Medical Birth Registry (2000-10-30) 3 Nielsen GL, Sorensen HT, Thulstrup AM, Tage-Jennsen U, Olesen C, Ekbom A: The afety of proton pump inhibitors in pregnancy. Aliment Pharmacol Ther 1999; 13: 1085-1089 4 Briggs GB, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 5th ed. Baltimore: Williams & Wilkins; 1998 5 Drugline no 17084 (year 2000)