[Drug surveillance and reproduction: the bad example of distilbene].
In the 1940's, diethylstilboestrol (DES) is one of the first hormonal therapeutics which was prescribed to many pregnant women by a lot of gynecologists. Until 1970, the indications of this therapy was enlarged, before carcinologic and reproductive consequences leaded to forbid obstetrical indications of DES (in France, in 1977 only). In France, 80,000 girls and 80,000 boys are suspected to have been exposed. As far as girls are concerned, the studies estimate between 23% and 36% the rate of infertility. These studies show also an increased incidence of ectopic pregnancy, spontaneous abortions, and premature delivery. The association between various factors of infertility, and typical uterine abnormalities leads to specific therapeutical indications, mostly in assisted procreations. The history of DES points out prescriptions of a therapeutic without proofs of its efficiency, the silence of pharmaceutical laboratories which did not take into consideration Dieckman's evaluation, and the difficulties for physicians in affording information. Nevertheless, the last patients exposed will be 40 years old in 2016 in France. The other hormonal therapeutics which were discovered gave in turn rise hope for enhancing the fertility and providing from miscarriage. Over the examples such as DES are not still resolved questions that patients and physicians ask concerning the lack of adverse effects of a therapy on the foetus, when its clinical efficiency on the pregnancy is supposed to be proved.
Epelboin
S
S
Maternité et centre de médecine de la reproduction, Service du Pr Jacques Chavinié, Hôpital Saint-Vincent-de-Paul, Paris.
Bulwa
S
S
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D004054:Diethylstilbestrol / Q000009:adverse effects*; D004341:Drug Evaluation; D004345:Drug Industry; D016903:Drug Monitoring; D011307:Drug Prescriptions; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects; D012098:Reproduction / Q000187:drug effects*
D004054:Diethylstilbestrol
Pharmacovigilance et reproduction: le mauvais exemple du Distilbène.