Dáil Éireann Debate, Tuesday - 15 September 2020
691. Deputy Kathleen Funchion asked the Minister for Health if his attention has been drawn to cases regarding the drug Duogynon (details supplied); and the research undertaken by his Department on the use of this drug. [23491/20]
Amharc ar fhreagraDuogynon (which was also known by the brand name Primodos in the UK), was a hormonal pregnancy test which was never authorised (i.e. licensed for use) in Ireland, although it is understood that the product was available in Ireland during the 1970s, with distribution discontinued in 1978.
The National Drugs Advisory Board (NDAB), which was a predecessor of the Health Products Regulatory Authority (HPRA), received five reports of suspected adverse reactions associated with use of Duogynon between 1976 – 1980, involving congenital abnormalities, for which very limited information is available.
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 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. This correspondence and information was also highlighted in the NDAB Annual Report for 1975.
The Department of Health has not undertaken any research into the historical use of Duogynon.
