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Safety of diclofenac use during early pregnancy: A prospective observational cohort study

Stephanie Padberg1, Tatjana Tissen-Diabaté1, Katarina Dathe1

  • 1Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology, Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Augustenburger Platz 1, 13353, Berlin, Germany.

Reproductive Toxicology (Elmsford, N.Y.)
|February 26, 2018
PubMed

Diclofenac is a widely used analgesic so that exposure during pregnancy may frequently occur. Most publications have evaluated the safety of NSAIDs on pregnancy outcome as a group of substances. Specific data on diclofenac are rare. This observational cohort study used the German Embryotox pharmacovigilance database to assess the risk of major birth defects and spontaneous abortion after first trimester exposure to diclofenac. A group of 260 women who took diclofenac during first trimester was compared to 778 non-exposed pregnancies. In the diclofenac exposed cohort 4 major birth defects were observed among 220 live-born infants and 25 spontaneous abortions occurred. Neither the rate of major birth defects (1.8% vs. 3.1%; OR adjusted 0.59; 95% CI 0.17-2.08) nor the risk of spontaneous abortion (HR adjusted 0.90; 95% CI 0.56-1.46) was increased. The study results do not indicate that diclofenac exposure during first trimester is associated with a teratogenic risk.

Keywords:
Birth defectDiclofenacNon-steroidal anti-inflammatory drug (NSAID)Pregnancy outcomeSpontaneous abortion

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