estradiol-benzoate--progesterone-drug-combination and Abnormalities--Drug-Induced

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.

Topics: Abnormalities, Drug-Induced; Bladder Exstrophy; Congenital Abnormalities; Drug Combinations; Estradiol; Female; Germany; Humans; Kidney; Kidney Diseases; Maternal Exposure; Maternal-Fetal Exchange; Neural Tube Defects; Odds Ratio; Pregnancy; Prenatal Exposure Delayed Effects; Progesterone

Topics: Abnormalities, Drug-Induced; Adult; Animals; Drug Combinations; Estradiol; Female; Humans; Limb Deformities, Congenital; Menstruation Disturbances; Pregnancy; Pregnancy Tests; Progesterone; Retrospective Studies

From 1964 to 1976, a cohort study was performed in West Germany to study the possible influence of various factors on pregnancy and child development. Results of the evaluation of 13,643 pregnancies are given with respect to possible teratogenetic effects of antiemetic drugs and sex hormones administered in early pregnancy. There was no evidence of an increased risk of major malformations following the intake of certain antiemetic drugs and progesterone. Also, the use of a hormonal pregnancy test was not significantly associated with an increase of major malformations.

Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Estradiol; Female; Germany, West; Humans; Pregnancy; Progesterone; Prospective Studies; Pyridoxine; Time Factors

I.N.S.E.R.M. has carried out two prospective inquiries centred on the evaluation of the teratogenic action of drugs on human beings. The first survey was between 1963 and 1969 and the second between 1975 and 1977 and they were carried out in maternity hospitals. The first test, which was carried out on 12,764 women, had shown no overall association between the use of hormonal tests for the diagnosis of pregnancy (oestrogens-progestogens) and congenital malformation in the infant. The second study, which was carried out on 3,451 women who were questioned in the same way, shows that there is an excessive number of newborn babies with malformations when the mothers took certain products (oestrogens-progestogens when the progestogen was a derivative of testosterone). The problem of a methodological bias is discussed and the results are interpreted in the light of epidemiological studies that have recently been carried out abroad.

Topics: Abnormalities, Drug-Induced; Drug Combinations; Estradiol; Female; Humans; Infant, Newborn; Pregnancy; Pregnancy Tests; Progesterone; Prospective Studies; Testosterone