Frågedatum: 1994-11-07
RELIS database 1994; id.nr. 10287, DRUGLINE
www.svelic.se
Utredningen som riktar sig till hälso- och sjukvårdspersonal, har utformats utefter tillgänglig litteratur och resurser vid tidpunkten för utredning. Innehållet i utredningen uppdateras inte. Hälso- och sjukvårdspersonal är ansvarig för hur de använder informationen vid rådgivning eller behandling av patienter.


A 28-year-old woman who is in week 6 of pregnancy has recently taken omeprazole. Is there any incre



Fråga: A 28-year-old woman who is in week 6 of pregnancy has recently taken omeprazole. Is there any increased risk of malformations or other adverse effects on the fetus?

Sammanfattning: Omeprazole is not teratogenic in standard animal models. There are no case reports published in which omeprazole intake during pregnancy has resulted in an adverse effect on the pregnancy. Four cases have been published in which omeprazole has been used during the first trimester and in which the outcome was successful. Thus, it is concluded that early intake of omeprazole during pregnancy is not an indication for abortion. Experience is at present too scarce to conclude that omeprazole is safe during

pregnancy. On the other hand there is yet no information suggesting the converse.

Svar: According to FASS (1) omeprazole belongs to category B1. The drug is a quite recent arrival on the market but its use has rapidly become widespread. It is therefore reasonable to assume that many women have been accidentally exposed to omeprazole in early pregnancy but there are no case reports suggesting a connection between an adverse outcome of pregnancy and intake of omeprazole. The literature contains four cases in which omeprazole has been used in early pregnancy (2,3,4,5). The outcomes in these pregnancies were successful. No malformations were noted in the children. 1 FASS 1994 2 Adamo S, Carrara M, Azzurro M, Sartori G, Vita G, Ghidini O: Omeprazole treatment during first month of pregnancy: a case report. Ital J Gastroenterol 1993; 25(suppl 1): 1 (abstract) 3 Hollenz M: Hyperemisis gravidarum. Therapie mit omeprazol. Ein Fallbericht. TW Gynäkologie 1993; 6: 150-151 (case report) 4 Hollenz M: Omeprazol in der Schwangerschaft. Ein Fallbericht. Therapiewoche Schweiz 1992; 8: 523-524 (Case report) 5 Glasbrenner B, Swobodnik W, Malfertheiner P, Ditschuneit H: Schweres Schwangerschaftserbrechen - Pathophysiologische Beobachtungen und neuer therapeutischer Ansatz. Z Gastroenterol 1991; 29: 163-166 (Case report)

Referenser: