(2003; 14 pages)
DIETHYL-STILBESTROL - Gynaecological and obstetric complications after in utero exposure
Canada. The Marketed Health Products and Therapeutic Products Directorates of Health Canada have drawn attention to a recent letter issued to prescribers in France by the French regulatory agency (AFSSAPS), now posted on the Heath Canada website, regarding the risks of gynaecological and obstetric complications in women exposed to diethylstilbestrol in utero. In France, between 1948 and 1976, approximately 200 000 pregnant women received diethylstilbestrol (Distilbène; Stilboestrol-Borne) treatment, which at the time was indicated to prevent miscarriage and pregnancy-related bleeding. The number of children born of these pregnancies, now aged 25 52 years, is estimated to be around 160 000 and problems related to in utero diethyl-stilbestrol exposure are therefore expected to occur until around 2015.
Compared with the general population, men who were exposed to diethylstilbestrol in utero have an increased risk of pathologies affecting the urogenital system, including epididymal cysts, testicular abnormalities and abnormalities of the urinary meatus. The primary complications seen in women exposed to diethyl-stilbestrol in utero are clear cell adenocarcinoma of the vagina or cervix, and structural, morphological and functional abnormalities involving the vagina, cervix, uterus and fallopian tubes; some of these pathologies can result in fertility problems and obstetric complications.
The letter advises that if in utero diethylstilbestrol exposure is suspected the patient should be referred to a specialist and should consult a gynaecologist annually. All pregnancies in women exposed to diethylstilbestrol should be treated as high risk, although the majority will have normal outcomes.
Important drug safety information from Health Canada, 18 Mar 2003. Available from URL: http://www.hc-sc.gc.ca