10/22/2019 Use of Nimesulide During Early Pregnancy and the Risk of Congenital Malformations: A Population-Based Study from Italy.

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Use of Nimesulide During Early Pregnancy and the Risk of Congenital Malformations: A
Population-Based Study from Italy.
Adv Ther. 2018; 35(7):981-992 (ISSN: 1865-8652)

Cantarutti A; Franchi M; Rea F; Merlino L; Corrao G

INTRODUCTION: Nimesulide is the most prescribed non-steroidal anti-inflammatory drug in Italy, and it is currently
marketed in about 50 countries worldwide. The association between the use of nimesulide in early pregnancy and the
risk of birth defects was investigated in a large cohort of pregnant women from Italy.

METHODS: Data were from the healthcare utilization databases of the Italian region of Lombardy. The cohort of
353,081 newborns occurring in Lombardy during the period 2005-2010 was investigated. Exposure to nimesulide
during the first trimester of pregnancy, and congenital malformations detected at presentation and within 90 days after
birth (outcome), were investigated. Exposure-outcome association was measured by the ratio between the prevalence
of congenital malformations among users and non-users of nimesulide. Propensity score stratification was used to
control for potential confounders, including maternal medical comorbidities, concomitant medications and
sociodemographic characteristics.

RESULTS: The 627 (0.18%) women who filled prescriptions for nimesulide in the first trimester of pregnancy had a 2.6-
fold risk of having children with congenital urinary tract anomalies compared to those who did not (adjusted prevalence
ratio 2.6; 95% CI 1.2-5.7). Weaker and non-significant evidence for congenital malformations as a whole was found
(adjusted prevalence ratio 1.2, 95% CI 0.9-1.6).

CONCLUSION: Our study suggests that the use of nimesulide in early pregnancy may result in a greater risk of having
births with congenital urinary tract anomalies.

FUNDING: This study was funded by grants from the Italian Ministry of the Education, University and Research
('Fondo d'Ateneo per la Ricerca' portion, year 2015).

Major Subject Heading(s) Minor Subject Heading(s) CAS Registry / EC

Numbers

Abnormalities, Drug-Induced Adult 0 (Anti-Inflammatory

[diagnosis] [epidemiology] [etiology] Anti-Inflammatory Agents, Non-Steroidal Agents, Non-Steroidal)
Maternal Exposure [prevention & [administration & dosage] [adverse effects] 0 (Sulfonamides)
control] [statistics & numerical data] Drug Utilization [statistics & numerical data] V4TKW1454M
Sulfonamides [administration & Female (nimesulide)
dosage] [adverse effects]
Humans
Infant, Newborn
Italy [epidemiology]
Pregnancy
Pregnancy Trimester, First [drug effects]
Risk Assessment
Urinary Tract [abnormalities]

PreMedline Identifier: 29923044

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
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10/22/2019 Use of Nimesulide During Early Pregnancy and the Risk of Congenital Malformations: A Population-Based Study from Italy.

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