Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules.
BACKGROUND
Little information is available about the safety of high doses of mesalazine during pregnancy.


OBJECTIVE
To study the fate of pregnancy and foetal outcome in women taking 1-4 g/day of mesalazine microgranules for inflammatory bowel disease.


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 > or =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 < or =2 g/day, and probably also at a dose of 3 g/day.
Marteau
P
P
Service d'Hépato-gastroentérologie, Hôpital Laënnec, Paris, France. philippe.marteau@lnc.ap-hop-paris.fr
Tennenbaum
R
R
Elefant
E
E
Lémann
M
M
Cosnes
J
J
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012189:Retrospective Studies; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine