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Research ArticleArticle

Major Malformations Following Exposure to Nonsteroidal Antiinflammatory Drugs During the First Trimester of Pregnancy

Sharon Daniel, Ilan Matok, Rafael Gorodischer, Gideon Koren, Elia Uziel, Arnon Wiznitzer and Amalia Levy
The Journal of Rheumatology September 2012, jrheum.120453; DOI: https://doi.org/10.3899/jrheum.120453
Sharon Daniel
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Ilan Matok
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Rafael Gorodischer
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Gideon Koren
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Elia Uziel
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Arnon Wiznitzer
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Amalia Levy
From the Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion University of the Negev, and Soroka Medical Center, Beer Sheva, Israel; and The Hospital for Sick Children, and The University of Toronto, Toronto, Ontario, Canada. S. Daniel, MD, MPH, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration (BeMORE), Ben-Gurion University of the Negev; I. Matok, MSc, Pharm, PhD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; R. Gorodischer, MD, Department of Pediatrics, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); G. Koren, MD, Motherisk Program, Division of Clinical Pharmacology-Toxicology, Hospital for Sick Children, BeMORE; E. Uziel, MSc, Social Work Services, Soroka Medical Center; A. Wiznitzer, MD, Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka Medical Center, Clalit Health Services (Southern District); A. Levy, MPH, PhD, Department of Epidemiology and Health Services Evaluation, Faculty of Health Sciences, BeMORE, Ben-Gurion University of the Negev. Address correspondence to A. Levy, Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, PO Box 653, Beer-Sheva 84105, Israel. E-mail: lamalia@bgu.ac.il Accepted for publication July 11, 2012.
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Abstract

Objective Nonsteroidal antiinflammatory drugs (NSAID) are among the most common medicines used by pregnant women. Published data are controversial regarding fetal safety following intrauterine exposure to NSAID. We investigated exposure to NSAID in the first trimester in a large cohort of infants and fetuses.

Methods A computerized database of medications dispensed from 1998 to 2009 to all women registered in the “Clalit” health maintenance organization in Southern Israel was linked with 2 computerized databases containing maternal and infant hospitalization records. Pregnancy terminations for medical reasons were analyzed. The following confounders were controlled for: parity, maternal age, ethnicity, maternal pregestational diabetes, maternal inflammatory disease, and year of birth or pregnancy termination. First trimester exposure to nonselective cyclooxygenase (COX) inhibitors and to selective COX-2 inhibitors as groups and to individual drugs was analyzed.

Results There were 110,783 pregnancies during the study period: 109,544 singleton births and 1239 pregnancy terminations for medical reasons. In total, 5267 mothers were exposed to NSAID during the first trimester of pregnancy: 5153 to nonselective COX inhibitors and 114 to COX-2 selective inhibitors. Exposure to NSAID in the first trimester, as groups (nonselective COX and selective COX-2 inhibitors) and as individual drugs, was not associated with an increased risk of major congenital malformations in general (adjusted OR 1.07, 95% CI 0.96−1.21 for nonselective; and adjusted OR 1.40, 95% CI 0.70−2.78, for selective COX-2 inhibitors), although an increased risk for musculoskeletal malformations was found following exposure to COX-2 selective inhibitors (adjusted OR 3.39, 95% CI 1.37−8.34).

Conclusion Intrauterine exposure to NSAID was not associated with increased risk for major congenital malformations. Further studies are needed to assess the risk for malformations after exposure to COX-2 selective inhibitors.

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Major Malformations Following Exposure to Nonsteroidal Antiinflammatory Drugs During the First Trimester of Pregnancy
Sharon Daniel, Ilan Matok, Rafael Gorodischer, Gideon Koren, Elia Uziel, Arnon Wiznitzer, Amalia Levy
The Journal of Rheumatology Sep 2012, jrheum.120453; DOI: 10.3899/jrheum.120453

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Major Malformations Following Exposure to Nonsteroidal Antiinflammatory Drugs During the First Trimester of Pregnancy
Sharon Daniel, Ilan Matok, Rafael Gorodischer, Gideon Koren, Elia Uziel, Arnon Wiznitzer, Amalia Levy
The Journal of Rheumatology Sep 2012, jrheum.120453; DOI: 10.3899/jrheum.120453
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