Bríd Smith (Dublin South Central, People Before Profit Alliance)
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250. To ask the Minister for Health if his attention has been drawn to reports that a drug (details supplied) prescribed to women during pregnancy in both New Zealand and Britain has been linked to adverse heath issues and outcomes; if this drug is or was available to women here; and if he will make a statement on the matter. [52613/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA has stated that Hormonal Pregnancy Tests (HPTs) such as Primodos and Duogynon were never authorised (i.e. licensed) for use in Ireland. However, it is understood that Duogynon was available in Ireland up to the 1970s, with distribution discontinued in 1978.

Although never authorised for use in Ireland, the 1975 annual report of the National Drugs Advisory Board (NDAB, a predecessor of the HPRA) outlined the consideration given by the NDAB to the use of hormonal testing for pregnancy. This report related to hormonal pregnancy testing preparations in general, and did not mention any specific product. In April 1975, the NDAB issued a warning letter to practitioners regarding the use of hormonal pregnancy testing preparations. This letter reminded practitioners that these preparations had not been assessed by the NDAB, and that their use as a means of pregnancy testing had not been accepted by the NDAB. The letter also highlighted that these preparations should be avoided, as a firm statement of safety could not be given and other, more efficient methods of pregnancy testing were available.

While not an authorised medicinal product in Ireland, five reports of suspected adverse reactions associated with use of Duogynon were received by the NDAB between 1976 and 1980, describing suspected congenital abnormalities. There is very limited information available in relation to these reports.

The HPRA has no information regarding the numbers of women in Ireland who may have used Duogynon for diagnosis of their pregnancies in the 1970s.

In the UK, where HPTs were licensed (and where they were used from the early 1950s to 1978), an Expert Working Group of the UK’s Commission on Human Medicines recently completed a review of this issue and published a report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy, including possible birth defects. This report concluded that following extensive and rigorous review, based on the totality of the available data, that the scientific evidence does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage.