Primodos: Daughter wants to ease mum's guilt over pregnancy test families say caused birth defects

A daughter plagued with health issues says she hopes a legal bid will finally ease her mother's guilt over taking a pregnancy test drug she believes caused her birth defects.

Tracey Newton was born with two dislocated hips, a compromised immune system and enlarged liver, spleen and heart.

The 55-year-old, from Little Ouse near Ely in Cambridgeshire, believes her health problems were caused by two hormonal contraceptive tablets given to her mother by a doctor in 1967.

Those tablets were called Primodos and were offered to mothers in the 1950s and 1960s as an oral pregnancy test which could give a result sooner than a traditional urine test.

Now families from across the country are bidding to take the drug's manufacturers, and the UK government, to court to prove they caused harm to hundreds of babies.

Mrs Newton said when her mother, Joan Panter, went to her doctor, her GP took the tablets from a drawer in his desk, explaining it was a "new thing".

It was not until she was an adult herself, and she discovered campaign group the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), that she was told Primodos was around 40 times the strength of an oral contraceptive.

"You can imagine the guilt she had from taking them, but it wasn't her fault," said Mrs Newton.

"I'm sure my mum wouldn't have taken the pills if they had told her that."

Mrs Newton, who at times relies on a wheelchair because of ongoing issues with her hips, added: "It's like taking the morning after pill to check if you are pregnant.

"Nowadays you can check on the internet, do your own research, but you couldn't do it then. Your doctor was God, almost."

Mrs Newton had two older brothers who were both born healthy. Her mother was only given Primodos during her pregnancy with her daughter.

What is Primodos?

Primodos was made by drug company Schering - which was later bought by Bayer - and, according to the Open University, was marketed as a hormone pregnancy test between 1958 and 1970.

Between 1970 and 1978, it was used only to treat secondary amenorrhea - when someone's periods stop for three months or more - and was withdrawn from the UK market after that.

Concerns about a possible link with birth anomalies was first raised in a study in 1967.

The "First Do No Harm review", published in 2020, found the use of hormone pregnancy tests should have been stopped more than a decade before they were finally withdrawn and called on the government to issue a "fulsome apology" to families

In recent years, a number of studies have looked at a possible link between Primodos and birth defects.

In 2017, a review of evidence by an expert working group from the UK's Commission on Human Medicines concluded the data did not support a causal link between the two.

However analysis by Oxford University published in 2018 found hormone pregnancy tests, such as Primodos, were associated with birth malformations.

Campaigners are waiting for a High Court ruling on whether they can take their civil case to court, following a hearing at the start of this month.

They want to sue both Bayer - as the current owner of the company which manufactured the drug - and the government for failing to properly regulate the use of it.

Both oppose the action.

But ACDHPT said a court case would allow them to present new evidence

Marie Lyons' daughter Sarah Wilson was born with one arm that did not form below the elbow.

The 76-year-old, who was initially told by doctors in Wigan that "this is the kind of thing that can occur now and again" was told of a possible link with Primodos when Sarah was eight.

Mrs Lyons, who now chairs the campaign group, said: "We can't give up. We owe it now to women in the future, to families, to everyone who has been harmed.

"Once and for all we can all feel that guilt is no longer belonging to us - because that's how we feel, guilty. We took the tablets.

"That guilt needs to be where it deserves to be - with the regulators and the drug companies."

The Department for Health and Social Care said it could not comment on ongoing legal proceedings.

But, in a statement, Bayer said it denied "that Primodos was responsible for causing any congenital anomalies in children, miscarriages or stillbirth.

A previous case against Schering in 1982 was abandoned when the campaign group decided it had no realistic chance of winning.

"Since the discontinuation of the legal action in 1982, Bayer maintains that no significant new scientific knowledge has been produced that would call into question the validity of the previous assessment of there being no link between the use of Primodos and the occurrence of such congenital anomalies," a spokesman for Bayer added.

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