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Pregnancy Tests

Question for Department of Health

UIN 114880, tabled on 21 November 2017

To ask the Secretary of State for Health, what the Government's policy is on the conclusions of the Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, published in November 2017.

Answered on

29 November 2017

The Commission on Human Medicines published the report of its Expert Working Group on Hormone Pregnancy Tests on 15 November 2017. This was the culmination of an extensive and thorough review of all the available relevant evidence on a possible association between Hormone Pregnancy Tests and adverse outcomes of pregnancy by a panel comprising independent experts of international standing in relevant scientific and medical specialisms.

The Expert Working Group’s overall finding, endorsed by the Commission on Human Medicines, was that the available scientific evidence, taking all aspects into consideration, did not support a causal association between the use of Hormone Pregnancy Tests, such as Primodos, during early pregnancy and adverse outcomes of pregnancy, including miscarriage, stillbirth or congenital anomalies. The Expert Working Group also made a number of important, forward-looking recommendations to further strengthen the systems in place for detecting, evaluating, managing and communicating safety concerns associated with use of medicines in early pregnancy.

Departmental ministers have accepted the report’s conclusions and recommendations. The focus is now on implementing these recommendations.