Birth outcome in women exposed to 5-aminosalicylic acid during pregnancy: a Danish cohort study.
BACKGROUND
5-Aminosalicylic acid (5-ASA) preparations are the firstline drugs in the treatment of inflammatory bowel disease. Data on the safety of these drugs in pregnancy are sparse.


OBJECTIVE
To examine the risk of adverse birth outcome in women who were prescribed 5-ASA drugs during pregnancy.


METHODS
Women were included in the study if they were prescribed 5-ASA drugs immediately before or during pregnancy. To examine the risk of malformations, we included 60 pregnancies exposed to 5-ASA drugs 30 days before pregnancy or in the first trimester. To examine stillbirths, preterm births, and low birth weight, we included 88 pregnancies exposed during the entire pregnancy. Outcomes were compared with those of 19 418 pregnancies in which no drugs were prescribed for mothers during the study period.


METHODS
We conducted a Danish cohort study based on data from a population based prescription registry, the Danish Birth Registry, and the Hospital Discharge Registry in North Jutland County.


RESULTS
Odds ratios for malformations, stillbirth, preterm birth, and low birth weight in women who received prescriptions for 5-ASA drugs were 1.9 (95% confidence interval 0.7-5.4), 6.4 (1.7-24.9), 1.9 (0.9-3.9), and 1.2 (0.4-3.3), respectively. The increased risk of stillbirth and preterm birth were found only in patients with ulcerative colitis.


CONCLUSIONS
We found an increased risk of stillbirth and preterm birth in women who had been prescribed 5-ASA drugs during pregnancy but no substantial increased risk of malformations. It was difficult to distinguish the specific effects of disease activity and 5-ASA drugs.
Nørgård
B
B
Department of Clinical Epidemiology, Aarhus University Hospital, DK-8000 Aarhus C, Denmark. bn@soci.au.dk
Fonager
K
K
Pedersen
L
L
Jacobsen
B A
BA
Sørensen
H T
HT
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005313:Fetal Death; D005865:Gestational Age; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D019804:Mesalamine / Q000009:adverse effects*; D016017:Odds Ratio; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D012307:Risk Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine