Primodos was a hormone-based

pregnancy test A pregnancy test is used to determine whether a female is pregnant or not. The two primary methods are testing for the female pregnancy hormone (human chorionic gonadotropin (hCG)) in blood or urine using a pregnancy test kit, and scanning with u ...

used in the 1960s and 1970s that consisted of two pills that contained

norethisterone Norethisterone, also known as norethindrone and sold under many brand names, is a progestin medication used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication is available in ...

(as acetate) and

ethinylestradiol Ethinylestradiol (EE) is an estrogen medication which is used widely in birth control pills in combination with progestins. In the past, EE was widely used for various indications such as the treatment of menopausal symptoms, gynecological dis ...

.Department of Health, ''

Hansard ''Hansard'' is the traditional name of the transcripts of parliamentary debates in Britain and many Commonwealth countries. It is named after Thomas Curson Hansard (1776–1833), a London printer and publisher, who was the first official printe ...

'', HL Deb, 26 October 2010, c264

/ref> It detected pregnancy by inducing

menstruation Menstruation (also known as a period, among other colloquial terms) is the regular discharge of blood and mucosal tissue from the inner lining of the uterus through the vagina. The menstrual cycle is characterized by the rise and fall of ...

in women who were not pregnant. The presence or absence of

menstrual bleeding The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that make pregnancy possible. The ovarian cycle controls the production and release of eggs a ...

was then used to determine whether the user was pregnant. In South Korea it was also used, "perhaps as a double dose" to induce

abortion Abortion is the termination of a pregnancy by removal or expulsion of an embryo or fetus. An abortion that occurs without intervention is known as a miscarriage or "spontaneous abortion"; these occur in approximately 30% to 40% of pregn ...

s. While first made available for sale in the UK in 1959, it was withdrawn from sale in the UK in 1978. Primodos was produced by

Schering AG Schering AG was a research-centered German multinational pharmaceutical company headquartered in Wedding, Berlin, which operated as an independent company from 1851 to 2006. In 2006, it was bought by Bayer AG and merged to form the Bayer subsi ...

, a German company taken over by

Bayer AG Bayer AG (, commonly pronounced ; ) is a German multinational pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world. Headquartered in Leverkusen, Bayer's areas of business include pharmaceutica ...

in 2006. Another hormonal pregnancy test called Duogynon was in use in Germany during the same general time period.

History

In the 1960s, Dr. Isabel Gal conducted research at Queen Mary's Hospital for Children that showed a link between use of the drug and severe birth defects. A review by the Committee on Safety of Medicines in the 1970s concluded that the product should not be used by pregnant women. Litigation in the 1980s regarding these claims ended inconclusively, with proceedings being discontinued, with the court's approval. A review of the matter by the

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptabl ...

in 2014 assessed the studies performed to date, and concluded that it found the evidence for adverse effects to be inconclusive. The report of an expert working group of the UK Commission on Human Medicines published in November 2017 concluded there was no “causal association” between Primodos and severe disabilities in babies. The expert group recommended that families who took a hormone pregnancy test and experienced “an adverse pregnancy outcome” should be offered

genetic testing Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or ...

to establish whether there was a different underlying cause.

Independent Medicines and Medical Devices Safety Review

An independent review by Baroness Cumberlege, the Independent Medicines and Medical Devices Safety Review, reported in 2020 that "avoidable harm" resulted from the use of Primodos. It recommended that "the Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos". Dr Bill Inman, of the Committee on Safety of Medicines, who had investigated Primodos was referenced in a Schering memo stating "he has destroyed all the material on which his investigation is based, or made it unrecognizable, which makes it impossible to trace the individual cases taken into the investigation. I understood Dr. Inman that he did this to prevent individual claims from using this material." Baroness Cumberlege said, in relation to Bayer, "I think they should not only apologise; they should recognise what has happened and give ex-gratia payments to these people who have suffered."

History

Independent Medicines and Medical Devices Safety Review

References

Further reading