Is omeprazole safe to use during pregnancy?/nA woman pregnant in week 21 wants to begin an omeprazo

Fråga: Is omeprazole safe to use during pregnancy? A woman pregnant in week 21 wants to begin an omeprazole treatment due to gastritis.

Sammanfattning: "Antacids are the ""drugs of choice"" in pregnant women with gastritis or reflux disease. Published data on a moderate amount of women indicate that omeprazole does not have a significant harmful effect on the fetus. Therefore omeprazole can be tried during pregnancy if antacids do not suffice."

Svar: In week 21 there is no risk of structural malformations. Antacids do not have any significant harmful effect on the fetus (1). Therefore these medications are the "drugs of choice" for pregnant women with gastritis and reflux disease.

Whether omeprazole, a proton pump blocker, is harmful to the fetus has previously been reviewed in Drugline and the conclusion was that published data from a moderate number of observed women have not indicated that omeprazole is harmful to the fetus (2). Since then two more studies have been published.

One study (3) is of nine pregnant women who received omeprazole during pregnancy because of severe gastric reflux. Four took omeprazole at the time of conception, and 3 of these patients continued omeprazole therapy until delivery. One patient discontinued therapy in the 8th week of pregnancy but had to take the drug again from the 28th week to delivery. The other 5 patients started therapy in weeks 24, 30, 33, 34 and 36 of pregnancy. No severe side effects were observed in any of the mothers or their new-borns. No malformations or malfunctions were observed in the new-borns. Follow up of the children between 2 and 12 years showed normal development in all of the children.

In another study (4) 275 women who had used proton pump blockers were compared with 255 women who had used H2 receptor antagonists and 20 women who had used both medications. All these women had used the drugs early in the pregnancy. No effect of the use of omeprazole or H2-receptor antagonist on the rate of congenital malformations was seen. It was concluded that although a teratogenic effect of these medications cannot be ruled out, the individual risk after exposure during the first trimester seems to be negligible.

A literature search indicated that omeprazole crosses the placenta in humans. In studies of rats and rabbits with doses of omeprazole up to 345 and 172 times, respectively, the normal human dose produced no evidence of teratogenicity, but a dose-related embryo and fetal mortality was observed. FDA had through 1996 received 11 reports of specified birth defects following omeprazole. Four were of anencephaly and one was of hydrocephaly (5).