WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Ver el documento en el formato PDF
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Abrir esta carpeta y ver su contenidoREGULATORY MATTERS
Cerrar esta carpetaSAFETY OF MEDICINES
Ver el documentoANTIRETRO-VIRALS - Benefit/Risk balance remains strongly positive for combination antiretroviral therapy
Ver el documentoCYPROTERONE ACETATE & ETHINYL-ESTRADIOL - Update on risk of venous thromboembolism
Ver el documentoDIETHYL-STILBESTROL - Gynaecological and obstetric complications after in utero exposure
Ver el documentoEPHEDRA - Moves to reduce risks of ephedra-containing products
Ver el documentoFLUTICASONE PROPIONATE - Reports of adrenal crisis
Ver el documentoGRAPEFRUIT JUICE - Revised advice from ADRAC
Ver el documentoHORMONE REPLACEMENT THERAPY (HRT) - Risk of dementia
Ver el documentoOMEPRAZOLE, RABEPRAZOLE - Reports of interstitial nephritis
Ver el documentoROFECOXIB, CELECOXIB - Case reports support causal association with liver toxicity
Ver el documentoROSIGLITA-ZONE, PIOGLITAZONE - Adverse reactions update
Ver el documentoSOMATROPIN - Not to be authorized for AIDS-related wasting syndrome
Abrir esta carpeta y ver su contenidoCURRENT CONCERNS
Abrir esta carpeta y ver su contenidoDRUGS OF INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

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.

Reference:
Important drug safety information from Health Canada, 18 Mar 2003. Available from URL: http://www.hc-sc.gc.ca

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