Document Detail

Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules.
MedLine Citation:
PMID:  9845399     Owner:  NLM     Status:  MEDLINE    
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.
P Marteau; R Tennenbaum; E Elefant; M Lémann; J Cosnes
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  12     ISSN:  0269-2813     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  1998 Nov 
Date Detail:
Created Date:  1999-03-09     Completed Date:  1999-03-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1101-8     Citation Subset:  IM    
Service d'Hépato-gastroentérologie, Hôpital Laënnec, Paris, France.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*,  adverse effects
Chi-Square Distribution
Drug Administration Schedule
Inflammatory Bowel Diseases / drug therapy*
Mesalamine / administration & dosage*,  adverse effects
Pregnancy Complications / drug therapy*
Pregnancy Outcome*
Prospective Studies
Retrospective Studies
Statistics, Nonparametric
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 89-57-6/Mesalamine

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