Nuala Fennell
Question:237 Mrs. Fennell asked the Minister for Health if he will outline the information which the National Drugs Advisory Board had in 1974 in relation to the effectiveness and the likely ill-effects of diethyestilboestrol.
Written Answers. - Effects of Diethyestilboestrol.
In 1973 the National Drugs Advisory Board considered a number of published papers suggesting an association between the administration of diethystilboestrol at high doses in early pregnancy and the development of neoplastic vaginal pathology in adult female offspring of women so treated.
In 1974 the National Drugs Advisory Board again reviewed the position and concluded that stilboestrol, as distinct from the steroidal oestrogens, was capable of exerting a specific teratogenic effect on vaginal epithelium which led subsequently to neoplastic changes in some — approximately 0.1 per cent — of the affected individuals up to 20 years later, i.e., between ages of 19-30 years).
The board noted that in 1974 stilboestrol had a main indication in the management of prostatic carcinoma, a use for which it is still prescribed, and to a lesser degree a use in the management of post menopausal disorders, and indication for which it is no longer used although, as a vaginal pessary, it is still used for management of vaginal atrophy.
The only adverse effect reports received by the National Drugs Advisory Board from 1968 to 1974, inclusive, were as follows:
Male.Gynaecomastia and testicular atrophy.
Rash.
Oedema from fluid retention.
Retinal artery embolism.
No applications for approval for marketing were received by the National Drugs Advisory Board until 1979.