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Primodos: Research

The review referenced in Question 31168 considered the 2023 publication by Danielsson et al only. The Medicines and Healthcare products Regulatory Agency’s (MHRA) assessment of this publication focussed on new data, which concerned transient embryonic hypoxia and teratogenicity in relation to oral hormone pregnancy tests (HPTs), and has been published at the following link:

https://assets.publishing.service.gov.uk/media/68b0696bf31f3b16cee0e937/Evaluation_of_review_of_transient_embryonic_hypoxia_and_teratogenicity_in_relation_to_oral_hormone_pregnancy_tests__including_Primodos.pdf

This MHRA assessment was considered by the Commission on Human Medicines (CHM) in November 2024. A copy of the minutes of this CHM meeting is attached.

The study referenced by Mr Roland Moyle on 26 May 1978 is titled Maternal drug histories and congenital anomalies, and is authored by Greenberg G, Inman WHW, Weatherall, JAC et al. This was published in the British Medical Journal in October 1977, and is available at the following link:

https://www.bmj.com/content/2/6091/853.abstract

The original Expert Working Group (EWG) convened by the United Kingdom’s CHM to review all available evidence on the possible association between HPTs and adverse outcomes in pregnancy considered the study by Greenberg G referenced above as part of their review.

The EWG reported its findings in November 2017 and concluded that the totality of the available scientific data does not support a causal association between the use of HPTs during early pregnancy and adverse pregnancy outcomes. The EWG report on the use of HPTs and adverse effects relating to pregnancy, including possible birth defects, is published online, at the following link:

https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-hormone-pregnancy-tests

The MHRA remains committed to reviewing any new scientific data which becomes available following the conclusion of the EWG.