What is Primodos and what was the birth defect scandal linked to the drug?

THE oral hormone-based pregnancy test Primodos was given to women in the UK in the 1960s and 1970s by their GPs.

Now, parents claiming their babies were affected by the drug have said they're preparing to sue its makers and the Government.

What is Primodos and what is it used for?

Primodos was a hormone-based medication given to pregnant women to detect pregnancy between 1958 and 1978.

Around 1.5million women in Britain were given Primodos.

It consisted of two pills that contained high levels of synthetic progestin and oestrogen hormones.

Those hormones would be later used in the morning after pill.

What was the Primodos pregnancy test drug?

Primodos maker Schering instructed women to "take one tablet on each of two consecutive days.

It said: "Bleeding follows in three to six (rarely as long as ten) days, if there is no pregnancy.

"An existing pregnancy is unaffected by Primodos.”

It was removed from the market in 1977 after concerns were raised but they were not proven.

In 1978, Primodos was discontinued after doctors noticed an increase in the number of deformed babies born to mothers who had been on the drug.

Primodos was manufactured by the drug company Schering, now part of Bayer, which continues to deny it caused deformities in children.

What birth defects has Primodos allegedly caused and how have people suffered?

There are disputed claims as to whether Primodos may have been the cause of birth defects.

For decades, families have believed Primodos has been responsible for serious deformities in their children including missing limbs, brain damage, heart defects and spina bifida - often leading to early death.

It is also feared many women who took the pills to find out if they were expecting may have caused their embryo to die without realising.

The government ordered an expert working group (EWG), lead by Oxford and overseen by the Medicines and Healthcare products Regulation Agency (MHRA), to investigate the matter in 2017.

Research found that the drug was likely harming unborn children before it was pulled from the UK market in 1978.

Campaigners used a freedom of information request to get hold of the raw data used in the research.

An Oxford University professor suggested that the government-commissioned review team failed to assess the risks of the drug and didn't provide all their results.

Last year the review found that there was a link between Primodos and birth defects.

Previous examinations of the drug's effect concluded that the 1.5million women given Primodos were five times more likely to have disabled children than those who didn't take the drug.

The investigation also revealed that the drug, containing super-strength hormones which would later be used in the morning-after pill, were never tested before being given to women.

In Germany, where the drug was called Duogynon, doctors told the manufacturer it was widely being prescribed to terminate unwanted pregnancies.

A 2014 review by the Medicines and Healthcare Products Regulatory Agency assessed past studies and concluded the evidence for adverse effects was inconclusive.

In November 2017 the UK Commission on Human Medicines found there was no evidence of a "casual association" between Primodos and severe disabilities in babies.

A new study revealed in February 2018 that the drug had the potential to deform embryos in the womb.

Dr Neil Vargesson of Aberdeen University applied the drug to zebrafish embryos and recorded they suffered deformities included shortened tails and spine, fin and eye defects.

He also found the drug caused greater damage the earlier an embryo is exposed to it, and that higher doses can be lethal.

Also in February 2018, PM Theresa May ordered a review into the use of Primodos, vaginal mesh implants and anti-epilepsy drug sodium valproate.