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Congenital bladder exstrophy associated with Duogynon hormonal pregnancy tests-signal for teratogenicity or consumer report bias?
Tümmler, Gregor; Rißmann, Anke; Meister, Reinhard; Schaefer, Christof.
Afiliación
  • Tümmler G; Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité - University Clinic Berlin, Berlin, Germany.
  • Rißmann A; Malformation Monitoring Centre Saxony-Anhalt, Medical Faculty Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
  • Meister R; Department of Mathematics, Beuth Hochschule für Technik Berlin (University of Applied Sciences), Berlin, Germany.
  • Schaefer C; Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité - University Clinic Berlin, Berlin, Germany. Electronic address: christof.schaefer@charite.de.
Reprod Toxicol ; 45: 14-9, 2014 Jun.
Article en En | MEDLINE | ID: mdl-24389232
A combination of ethinylestradiol and 10mg norethisterone under the brand names of Duogynon (Germany) or Primodos (UK) was used as a pregnancy test until the 1970s. Until very recently there was continuing public concern about the safety of these drugs and legal proceedings were instituted against the medicinal authorization holder. Given the lack of epidemiological studies focusing on Duogynon/Primodos, the present study evaluates 296 consumer reports of the German Duogynon database and compares the reported birth defects with data from a population based birth registry. The most striking result is an increase of bladder exstrophy (OR=37.27; 95%-CI 14.56-95.28). Neural tube defects (OR=2.99; 95%-CI 1.85-4.84) and renal agenesis (OR=2.53; 95%-CI 1.17-5.45) were also significantly increased. Bladder exstrophy may be a yet undetected teratogenic effect of Duogynon, but may also represent a reporting bias. The present study highlights the difficulties of evaluating consumer reports which may be influenced by public media.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Efectos Tardíos de la Exposición Prenatal / Progesterona / Anomalías Inducidas por Medicamentos / Extrofia de la Vejiga / Estradiol Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Female / Humans / Pregnancy País/Región como asunto: Europa Idioma: En Revista: Reprod Toxicol Asunto de la revista: EMBRIOLOGIA / MEDICINA REPRODUTIVA / TOXICOLOGIA Año: 2014 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Efectos Tardíos de la Exposición Prenatal / Progesterona / Anomalías Inducidas por Medicamentos / Extrofia de la Vejiga / Estradiol Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Female / Humans / Pregnancy País/Región como asunto: Europa Idioma: En Revista: Reprod Toxicol Asunto de la revista: EMBRIOLOGIA / MEDICINA REPRODUTIVA / TOXICOLOGIA Año: 2014 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos