Pregnancy Outcome Following Exposure to Topical Retinoids: A Multicenter Prospective Study

Journal of Clinical Pharmacology - Tập 52 Số 12 - Trang 1844-1851 - 2012
Alice Panchaud1, Chantal Csajka2, Paul Merlob3, Christof Schaefer4, Maya Berlin5, Marco De Santis6, Thierry Vial7, Alessandra Ieri8, Heli Malm9, Georgios Eleftheriou10, Bracha Stahl3, Philippe Rousso1, Ursula Winterfeld1, Laura E. Rothuizen1, Thierry Buclin1
1Department of Swiss Teratogen Information Service and Division of Clinical Pharmacology and Toxicology, University Hospital, Lausanne, Switzerland
2Department of pharmaceutical sciences, University of Geneva, Geneva, Switzerland
3BELTIS, Rabin Medical Center, Petah Tikva, Israel
4Pharmakovigilanz‐ und Beratungszentrum Embryonaltoxikologie, Berlin, Germany
5Drug Consultation‐TIS, Zerifin, Israel
6Telefono Rosso‐TIS, Roma, Italia
7Pharmacovigilance, Lyon, France
8TIS AOU Careggi, Florence, Italy
9Teratology Information Service Helsinki University Central Hospital Helsinki Finland
10Poison Control, Bergamo, Italy

Tóm tắt

Concerns have been raised about the use of topical retinoids since the publication of isolated cases of characteristic retinoid embryopathy, originally described after oral use. A collaborative study of the European Network of Teratology Information Services was carried out to evaluate the rate of congenital malformations following first‐trimester topical retinoid exposure. A population of 235 exposed pregnant women was compared with 444 controls. No significant differences were observed between groups with regard to the rates of spontaneous abortion (odds ratio [95% confidence interval], 1.5 [0.8–2.7]), minor birth defects (1.3 [0.4–3.7]), and major birth defects (1.8 [0.6–5.4]). No child showed features of retinoid embryopathy. The rate of elective termination in the exposed group was increased 3‐fold (3.4 [1.5–7.8]). In conclusion, these results do not suggest an increased risk of retinoid embryopathy. However, according to current knowledge, topical retinoids cannot be advised for use during pregnancy because their risk/benefit ratio remains questionable.

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Journal of Clinical Pharmacology

Tập 52 Số 12

1844-1851

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