No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester - Evaluation of the national Embryotox cohort

Katarina Dathe; Anne-Katrin Fietz; Lucas William Pritchard; Stephanie Padberg; Stefanie Hultzsch; Katja Meixner; Reinhard Meister; Christof Schaefer

doi:10.1016/j.reprotox.2018.05.003

No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester - Evaluation of the national Embryotox cohort

Reprod Toxicol. 2018 Aug:79:32-38. doi: 10.1016/j.reprotox.2018.05.003. Epub 2018 May 12.

Authors

Katarina Dathe¹, Anne-Katrin Fietz², Lucas William Pritchard², Stephanie Padberg², Stefanie Hultzsch², Katja Meixner², Reinhard Meister³, Christof Schaefer²

Affiliations

¹ Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany. Electronic address: [email protected].
² Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany.
³ Beuth Hochschule für Technik - University of Applied Sciences, Department of Mathematics, Berlin, Germany.

PMID: 29763655
DOI: 10.1016/j.reprotox.2018.05.003

Abstract

Ibuprofen is an analgesic frequently used in the 1st and 2nd trimester of pregnancy. Most relevant studies deal with NSAID as a group and do not specifically focus on ibuprofen. In this study, 1117 women exposed to ibuprofen in the 1st trimester were compared to 2229 non-exposed women. Data were retrieved from the German Embryotox database. No significantly increased risk of major birth defects (4.8% vs. 4.1%; OR adjusted 1.11, 95% CI 0.75-1.64) or a distinct pattern of birth defects were found. The cumulative incidences of spontaneous abortions were similar across cohorts (15.5% vs. 16.6%; HR adjusted 0.85; 95% CI, 0.65-1.11). Subgroup analyses of pregnancies exposed for ≥7 (n = 223) and ≥30 days (n = 72) did not reveal a higher risk with increasing treatment duration. Ibuprofen does not seem to carry a substantial embryotoxic risk regarding the investigated endpoints.

Keywords: Abortions; Anti-inflammatory agents; Congenital abnormalities [MeSH]; Ibuprofen [MeSH]; Non-Steroidal [MesH]; Pharmacovigilance [MeSH]; Pregnancy outcome [MeSH]; Spontaneous [MeSH].

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Abnormalities, Drug-Induced / epidemiology
Abortion, Spontaneous / epidemiology
Analgesics / therapeutic use*
Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
Antipyretics / therapeutic use*
Cohort Studies
Female
Germany / epidemiology
Humans
Ibuprofen / therapeutic use*
Incidence
Maternal-Fetal Exchange
Pregnancy
Pregnancy Outcome
Pregnancy Trimester, First*

Substances

Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Ibuprofen