title: Congenital bladder exstrophy associated with Duogynon hormonal pregnancy tests-signal for teratogenicity or consumer report bias?
abstract: 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.
authors.affiliation: Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité - University Clinic Berlin, Berlin, Germany.
authors.forename: Gregor
authors.initials: G
authors.lastname: Tümmler
authors.affiliation: Malformation Monitoring Centre Saxony-Anhalt, Medical Faculty Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
authors.forename: Anke
authors.initials: A
authors.lastname: Rißmann
authors.affiliation: Department of Mathematics, Beuth Hochschule für Technik Berlin (University of Applied Sciences), Berlin, Germany.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Meister
authors.affiliation: Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité - University Clinic Berlin, Berlin, Germany. Electronic address: christof.schaefer@charite.de.
authors.forename: Christof
authors.initials: C
authors.lastname: Schaefer
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D001746:Bladder Exstrophy / Q000139:chemically induced* / Q000453:epidemiology; D000013:Congenital Abnormalities / Q000453:epidemiology; D004338:Drug Combinations; D004958:Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007668:Kidney / Q000002:abnormalities; D007674:Kidney Diseases / Q000139:chemically induced / Q000151:congenital / Q000453:epidemiology; D018811:Maternal Exposure / Q000009:adverse effects; D008431:Maternal-Fetal Exchange; D009436:Neural Tube Defects / Q000139:chemically induced / Q000453:epidemiology; D016017:Odds Ratio; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects; D011374:Progesterone / Q000009:adverse effects*
chemical_list: D004338:Drug Combinations; D011374:Progesterone; D004958:Estradiol; C025370:estradiol benzoate, progesterone drug combination
keywords: Bladder exstrophy; Duogynon; Hormonal pregnancy test; Norethisterone; Pregnancy; Primodos; Teratogen