| アブストラクト | OBJECTIVES: Cytomegalovirus (CMV) is the leading cause of congenital infection worldwide. Reference anti-CMV treatment is valganciclovir/ganciclovir, which is contraindicated in pregnancy given questions about teratogenicity. METHODS: We analysed reports from VigiBase, the world's largest safety database, and performed a disproportionality analysis of adverse pregnancy outcomes associated with (val)ganciclovir compared with any other drugs or with (val)aciclovir as comparators. RESULTS: Among 3 104 984 reports related to childbearing-age women or to pregnancy topics, 6186 were exposed to (val)ganciclovir or (val)aciclovir including 251 adverse pregnancy outcomes with (val)ganciclovir (n = 34) or (val)aciclovir (n = 217). We did not evidence any increased reporting of any adverse pregnancy outcome [miscarriage, stillbirth, small weight for gestational age, preterm birth (<37 weeks of gestation)] or birth defects with (val)ganciclovir compared with the use of (val)aciclovir during pregnancy. Four cases of oesophageal and anorectal atresia were identified with (val)ganciclovir, which may be related to concomitant drugs/medical conditions and require further analyses. CONCLUSIONS: These preliminary results require confirmation but suggest the possibility for trial evaluation of val(ganciclovir) in severe maternal or fetal CMV infections. |
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| 投稿者 | Contejean, Adrien; Leruez-Ville, Marianne; Treluyer, Jean-Marc; Tsatsaris, Vassilis; Ville, Yves; Charlier, Caroline; Chouchana, Laurent |
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| 組織名 | Universite Paris Cite, Paris, France.;Infectious Diseases Department, Cochin Port Royal University Hospital, AP-HP;Centre, 27 rue du Faubourg Saint Jacques, 75014 Paris, France.;Microbiology Unit, Necker-Enfants Malades University Hospital, AP-HP Centre,;Paris, France.;Universite Paris Cite, Imagine, FETUS, F-75015 Paris, France.;Regional Center of Pharmacovigilance, Pharmacology Department, Cochin Port Royal;University Hospital, AP-HP Centre, Paris, France.;Research Team EA7323 "Pharmacology and Therapeutic Assessment in Children and;Pregnant Women", Universite Paris Cite, Paris, France.;Obstetrical Department, Cochin Port Royal University Hospital, AP-HP Centre,;Obstetrical Department, Necker Enfants Malades University Hospital, AP-HP Centre,;Institut Pasteur, French National Reference Center and WHO Collaborating Center;Listeria, Paris, France.;Institut Pasteur, Biology of Infection Unit, Inserm U1117, Paris, France. |
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