Niamh Smyth (Cavan-Monaghan, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

346. To ask the Minister for Health if a drug (details supplied) was used here; and if he will make a statement on the matter. [2889/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

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 were never authorised (i.e. licensed) 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.

Between 1976 and 1980, the NDAB received five reports of suspected adverse reactions associated with the use of HPTs. There is very limited information available in relation to these reports.

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 an extensive and rigorous review, based on the totality of the available data, the scientific evidence does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage.