title: Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules.
abstract: 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.
authors.affiliation: Service d'Hépato-gastroentérologie, Hôpital Laënnec, Paris, France. philippe.marteau@lnc.ap-hop-paris.fr
authors.forename: P
authors.initials: P
authors.lastname: Marteau
authors.forename: R
authors.initials: R
authors.lastname: Tennenbaum
authors.forename: E
authors.initials: E
authors.lastname: Elefant
authors.forename: M
authors.initials: M
authors.lastname: Lémann
authors.forename: J
authors.initials: J
authors.lastname: Cosnes
mesh_terms: 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
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine