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The Primodos Scandal- What Actually Happened

Medics in the Making

Updated: Oct 9, 2022

By Nieffer Sharif


Primodos was a pregnancy test drug used during the 1960s and has led to decades of campaigns by parents who claim that the drug has caused birth defects and killed babies in the womb. In 2017, it was revealed by Sky News that documents containing information about the drug possible deforming/killing babies in the womb may have been withheld. Parents who believe that their babies were damaged by the drug have taken legal action against the government and manufacturers. However, only now has an independent review found that children suffered ‘avoidable harm’ from the drug and it should have been removed from the market back in 1967 when concerns were first raised.

What is Primodos?

Produced by a German pharmaceutical company called Schering AG (which was later taken over by Bayer AG), Primodos was a hormone-based pregnancy test drug that was used during the 1960s. They were an oral contraceptive made up of 10mg norethisterone (a medication used in birth control pills and menopausal hormone therapy) and 0.2mg of ethinylestradiol ( an oestrogen medication which is mainly used in birth control pills) At the time it was thought that if a woman was pregnant the large doses of progesterone would be absorbed into the body and if she wasn’t pregnant it would trigger menstruation.

The concentration of oestrogen was extremely high; about one dose of Primodos equates to 40 oral contraceptive pills. This led to Primodos being taken off the market in 1978 as there were concerns raised about the effect of the drug on unborn babies. However, the link has never been formally recognised by the regulators or the manufacturer.

What were the effects of Primodos?

At the time some research suggested that there might be a correlation between the use of Primodos and miscarriages, babies born with shortened limbs, abnormalities in their internal organs, brain damage and heart defects. As a result, many children with these birth defects died before reaching adulthood. Those who are still alive are deaf, dumb, and blind. 

The timeline of key events: 

1950- Primodos, the first hormonal pregnancy test is launched by Schering AG

1959- Primodos is first made available in the UK

1967- Dr Isabel Gal, a surrey based Paediatrician suggests in a letter to the Science journal Nature that Primodos is causing spina bifida (a birth defect where the spine and the spinal cord don’t form properly) in the children of mothers who have taken the drugs. 

1970: The Department of Health committee asks Schering to remove pregnancy testing as one of the uses of Primodos, stating it should only be used to treat irregular periods.

1975: A warning appears on Primodos packets saying: "May cause congenital abnormalities".

1978: Primodos is taken off the market in Britain amid allegations that hormonal pregnancy tests cause miscarriage and a range of birth defects

March 2017: Hidden papers unearthed in the Berlin National Archives of a study by Professor William Inman show that women who took a hormone pregnancy test were five times more likely to have a disabled child than those who didn’t take the drug. The findings are exposed in a Sky News documentary.

November 2017: UK Commission on Human Medicines publishes a report concluding evidence does not support a "causal association" between Primodos and malformations, stillbirths, or miscarriage.

To conclude, Primodos is a pill to determine pregnancy with extremely high doses of progesterone which led to multiple birth defects in babies and miscarriage.

Works Cited

“Ethinylestradiol.” DrugBank, www.drugbank.ca/drugs/DB00977.

“Norethisterone 5mg Tablets.” Norethisterone 5mg Tablets - Summary of Product Characteristics (SmPC) - (Emc), www.medicines.org.uk/emc/medicine/7257.

“Primodos.” SPG LAW, www.spglaw.co.uk/primodos-case/?utm_source=Electric&utm_medium=GoogleAdwords&utm_campaign=Primodos&gclid=Cj0KCQjwpZT5BRCdARIsAGEX0zl2-u_ce87Pj8ohl84w_c-vRr4zunpXLtI5XTEk9OMxg4lCag0m_NkaAoSLEALw_wcB.

“Primodos Was a Revolutionary Oral Pregnancy Test. But Was It Safe? | Jesse Olszynko-Gryn.” The Guardian, Guardian News and Media, 13 Oct. 2016, www.theguardian.com/science/the-h-word/2016/oct/13/primodos-was-a-revolutionary-oral-pregnancy-test-but-was-it-safe.

“Spina Bifida.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 17 Dec. 2019, www.mayoclinic.org/diseases-conditions/spina-bifida/symptoms-causes/syc-20377860#:~:text=Spina bifida is a birth,the tissues that enclose them.


Edited by: Simoni Shah

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