Maternal exposure to mycophenolate mofetil in pregnancy—Results of the ENTIS collaborative study

Hoeltzenbein, Maria; Eléfant, Élisabeth; Garayt, Christelle; Ornoy, Asher; Clementi, Mauizio; Maňáková, Eva; Merlob, Paul; Rodríguez‐Pinilla, Elvira; Rothuizen, Laura E.; Smorlesi, C; Winkel, Bernke te; Santis, Marco De; Stephens, Sally; Vial, Thierry; Weber-Schoendorfer, Corinna; Schaefer, Christof

doi:10.1016/j.reprotox.2010.05.036

Cited by 5 publications

(2 citation statements)

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“…As the labeling points out, spontaneous adverse event reporting does not give reliable prevalence rates, because adverse outcomes may be disproportionately reported compared to normal outcomes. An abstract from the European Network of Teratology Information Services reported that malformations occurred in 8 of 50 prospectively ascertained pregnancies after mycophenolate exposure, and that the miscarriage rate (excluding voluntary abortions) was 35% [Hoeltzenbein et al, 2010]. The malformations included microtia, tracheoesophageal fistula, hydronephrosis, and atrial septal defect.…”

Section: Pharmaceutical Productsmentioning

confidence: 99%

Teratogenic exposures

Običan

Scialli

2011

American J of Med Genetics Pt C

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A consideration of teratogenic exposures includes not only an agent (chemical, radiation, biologic) but an exposure level and timing of exposure. There are criteria by which exposures are evaluated for a causal connection with an abnormal outcome. We here review some teratogenic exposures and discuss how they were initially described and confirmed. We have limited our discussion to some of the exposures for which a connection to structural malformations has been accepted in some quarters, and we indicate some exposures for which a causal association awaits confirmation. We recommend that counselors find a reliable and updatable source of information on exposures during pregnancy.

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