Journal
REPRODUCTIVE TOXICOLOGY
Volume 60, Issue -, Pages 29-32Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.reprotox.2016.01.002
Keywords
Pregnancy outcome; Spontaneous abortion; Tocilizumab; Rheumatoid arthritis; Birth defects; Biologic disease-modifying antirheumatic drugs
Categories
Funding
- German Ministry of Health (BMG) [IIA5-2512FSB053]
- German Federal Institute for Drugs and Medical Devices (BfArM) [V-6308/68605/2011-2014]
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Tocilizumab (TCZ) is not recommended for use during pregnancy due to limited data, but pregnancies nevertheless occur and pregnant women need to be counseled about potential fetal risks. Participants of this study were recruited from the pool of callers who spontaneously contact the pharmacovigilance center Embryotox Berlin for risk assessment during pregnancy. Of 22 identified cases with TCZ exposure during pregnancy, 16 prospectively enrolled cases with maternal and two cases with paternal TCZ therapy could be completed. The outcomes of the 16 maternal cases were: four spontaneous abortions (SAB), one induced abortion for personal reasons and 11 live-born infants. Congenital malformations were not recorded, but one SAB at week 15+3 days was complicated by hydrops fetalis of unknown origin. An incidental continuation of TCZ into early pregnancy does not justify an elective termination. However, a detailed prenatal ultrasound should be offered. (C) 2016 Elsevier Inc. All rights reserved.
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