Premium
Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules
Author(s) -
Philippe Marteau,
Ruth Tennenbaum,
Élisabeth Eléfant,
Marc Lémann,
Jacques Cosnes
Publication year - 1998
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 - 10.1046/j.1365-2036.1998.00417.x
Subject(s) - mesalazine , medicine , pregnancy , inflammatory bowel disease , obstetrics , gestation , gynecology , gastroenterology , disease , biology , genetics
Background: Little information is available about the safety of high doses of mesalazine during pregnancy. Aim: To study the fate of pregnancy and foetal outcome in women taking 1–4 g/day of mesalazine microgranules for inflammatory bowel disease. Patients and methods: Case reports were collected from the Pharmacovigilance Department of Ferring SA, France, from a survey conducted in three gastroenterology units, and from a teratology information service. The evolution of pregnancy and foetal outcome were assessed by questionnaire. Results: The study covered a total of 123 pregnancies (126 foetuses). Ninety‐six women took mesalazine during the first trimester, 85 during the second and 83 during the third. The mean daily dose was 2.1 ± 0.8 g; 86 women received <3 g/day (low‐dose group), 37 women received ≥3 g/day (high‐dose group). The following abnormalities were observed in the low‐dose and high‐dose groups, respectively: ectopic pregnancy (1/0), spontaneous abortions (1/1), foetal death (0/1), premature deliveries (3/5, P < 0.05), congenital malformations (3/1) and one case of lethal oxalosis. Abnormalities were not considered to be related to mesalazine. Conclusions: The use of oral mesalazine microgranules during pregnancy is safe at doses ≤ 2 g/day, and probably also at a dose of 3 g/day.