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The safety of proton pump inhibitors in pregnancy: a multicentre prospective controlled study
Author(s) -
DiavCitrin O.,
Ar J.,
Shechtman S.,
Schaefer C.,
Tonningen M. R.,
Clementi M.,
Santis M.,
RobertGnansia E.,
Valti E.,
Malm H.,
Ornoy A.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02306.x
Subject(s) - pantoprazole , lansoprazole , omeprazole , medicine , pregnancy , proton pump inhibitor , prospective cohort study , obstetrics , genetics , biology
Summary Background : Proton pump inhibitors are used to treat gastro‐oesophageal reflux and peptic ulcers. Gastro‐oesophageal reflux is a common condition in pregnancy. Human pregnancy experience with lansoprazole or pantoprazole is very limited. More data exist on the safety of omeprazole in pregnancy. Aim : To assess the safety of proton pump inhibitors in pregnancy. Methods : The rate of major anomalies was compared between pregnant women exposed to omeprazole, lanzoprazole, or pantoprazole and a control group counselled for non‐teratogens. The study design is a multicentre ( n = 8), prospective, controlled study of the European Network of Teratology Information Services. Results : We followed up 295 pregnancies exposed to omeprazole [233 in the first trimester ( T 1 )], 62 to lansoprazole (55 in T 1 ) and 53 to pantoprazole (47 in T 1 ), and compared pregnancy outcome to that of 868 European Network of Teratology Information Services controls. The rate of major congenital anomalies did not differ between the exposed and control groups [omeprazole nine of 249 (3.6%), lansoprazole two of 51 (3.9%) and pantoprazole one of 48 (2.1%) vs. controls 30 of 792 = 3.8%]. No differences were found when exposure was limited to the first trimester after exclusion of genetic, cytogenetic or infectious anomalies. Conclusions : This study suggests that proton pump inhibitors do not represent a major teratogenic risk in humans.