Debate on hormone pregnancy tests

Hormone pregnancy tests

Drugs containing synthetic versions of the hormones progesterone and oestrogen were taken as a form of pregnancy test from the late 1950s until 1970s. Primodos was the most commonly used of these medications in the UK. Studies in the UK and elsewhere from the late 1960s to early 1970s suggested a link between the use of hormone pregnancy tests (HPTs) and a wide range of serious congenital abnormalities. HPTs were withdrawn from use in the late 1970s.

Legal cases

In 1977, the Association for Children Damaged by Hormone Pregnancy Tests initiated legal proceedings against Schering Chemicals Limited, the manufacturer of Primodos, on behalf of two children with heart defects. The claims were discontinued on 2 July 1982 after the judge found there was insufficient evidence linking Primodos to the conditions.

In 2019, new legal proceedings were initiated against three pharmaceutical companies who manufactured hormone pregnancy tests (Bayer Pharma AG, who purchased Schering Healthcare in 2006, Aventis Pharma and Amenorone Forte) and the Secretary of State for Health and Social Care, who was responsible for the regulation of the supply and use of medicines.

In May 2023, these new claims were struck out as an “abuse of process”. Mrs Justice Yip concluded that no new evidence to establish causation was available, and that there was “no viable plan to progress these claims and no real prospect of success”.

Evidence reviews

Multiple reviews of the evidence linking hormone pregnancy tests to congenital abnormalities have been published.

The Commission on Human Medicines Expert Working Group review was published in 2017; their report concluded that the evidence “does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage”.

The Independent Medicines and Medical Devices Safety Review

In July 2020, the report of the Independent Medicines and Medical Devices Safety Review, First Do No Harm, was published. The review was clear that the “question of causality” was outside the scope of its work. Nonetheless, it concluded that hormone pregnancy tests should not have been available from 1967 onwards, and recommended that those affected were entitled to support.

The Government did not accept the report’s recommendations in relation to the creation of specialist support centres for those affected by medicines used in pregnancy, or the creation of a redress scheme for those affected by hormone pregnancy tests.