You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Doctors urged to keep check on daughters of women who used pregnancy drug three decades ago

9 June 2004

Women whose mothers took a synthetic oestrogen called Stilboestrol, known also as Diethylstilboestrol (DES) during pregnancy some three or four decades ago would not be in fear of contracting a rare vaginal cancer but they may have other vaginal abnormalities which should be checked out by a gynaecologist, if they have not already done so, Australia's medicines watchdog, the Therapeutic Goods Administration (TGA), announced today.

Principal Medical Adviser with the TGA, Dr John McEwen, said that the Adverse Drug Reactions Advisory Committee (ADRAC) has reminded doctors in its latest Bulletin that daughters of women who took the drug in the 1950s and 1960s to prevent miscarriages should ensure that they follow the current national cervical and breast screening recommendations and should be reviewed by a gynaecologist, if they have not been previously.

Dr McEwen said that in 1971, an association was demonstrated between exposure in the womb to DES, and the development of the rare vaginal cancer CCAC in exposed daughters who were diagnosed at ages up to 22 years.

"In Australia there have only been 15 reported cases of the development of a rare cancer, clear cell adenocarcinoma (CCAC) of the vagina in women whose mothers had taken diethystilboestrol but it is considered that since the use of the drug for this purpose stopped in about 1972, all cancers should have been detected by now," Dr McEwen said.

He said, however that since the 1971 study other adverse effects associated with DES have been identified in DES daughters including:

  • vaginal and cervical adenosis is very common, with reported incidence as high as 90%
  • other histological and structural reproductive tract abnormalities have been reported (incidences range from 18% - 58%)
  • occurrence of cervical and vaginal dysplasia, squamous cell carcinoma-in-situ, and high grade squamous intraepithelial lesions is about doubled
  • infertility rates are slightly increased
  • pregnancy complication rates, such as premature deliveries, miscarriages, ectopic pregnancies and pre-eclampsia are increased

Dr McEwen said for the women who took DES ('DES mothers'), a small increase in the rate of breast cancer has been reported. The sons exposed to DES in utero ('DES sons') have an increased occurrence of epididymal cysts. Careful surveillance on the next generation is being maintained ('DES grandchildren'), but there is no clear evidence to date of adverse effects in the children of DES daughters or sons.

Sources of further information

  • The website of the US Centers for Disease Control has a very extensive set of materials about DES for health professionals and consumers.
  • In Victoria, there is a DES follow-up clinic at the Royal Women's Hospital; contact telephone number (03) 9344 2000.
  • The Cancer Council of NSW has screening recommendations for DES exposure.

Media Contact: Kay McNiece, Media Adviser, TGA, 0412 132 585

Update: 14 November 2007

Screening guidelines for women exposed to DES in utero

The NHMRC have approved guidelines, "Screening to Prevent Cervical Cancer: Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities", on 9 June 2005. These guidelines contain a section concerning women exposed in utero to diethylstilboestrol (DES). The guidelines advise that women with DES exposure should be offered annual cytological screening and colposcopic examination of both the cervix and the vagina.