Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules

Aliment Pharmacol Ther. 1998 Nov;12(11):1101-8. doi: 10.1046/j.1365-2036.1998.00417.x.


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 > 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Chi-Square Distribution
  • Drug Administration Schedule
  • Female
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Mesalamine / administration & dosage*
  • Mesalamine / adverse effects
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Outcome*
  • Prospective Studies
  • Retrospective Studies
  • Statistics, Nonparametric
  • Surveys and Questionnaires


  • Anti-Inflammatory Agents, Non-Steroidal
  • Mesalamine