Irish women complained to medicines watchdog after taking pregnancy test drug and giving birth to babies with abnormalities
A number of Irish mothers believed their babies were left with abnormalities as a result of a hormonal pregnancy test drug which is at the centre of a fresh scandal.
Primodos, also marketed as Dougynon, was introduced in the 1960s as a method of detecting pregnancy by drugs manufacturer Schering.
While, it was never licensed for use in Ireland, it was available and, despite a warning issued in 1975 to all doctors, expectant mums were prescribed the pills until 1978 when it was removed from the market.
The pill was a high dose of hormones that, it was assumed, a pregnant woman would be able to absorb. Meanwhile, a woman who was not pregnant would have menstruation triggered.
There were two pills and the drug was given to millions of women around the world. The concentration of hormones would later be used in the morning after pill, in much, much smaller doses.
The drugs are the focus of a new Sky Atlantic documentary six years in the making called ‘Primodos: The Forgotten Drug Scandal’.
Reporter Jason Farrell, who was granted access to archives in Germany, claims evidence he found there shows that UK officials were aware of a possible link between the drug and abnormalities.
He has also found archived material which shows that the manufacturer of the drug was concerned that it would be found to have neglected its duty during a court case which was ultimately stalled.
Independent.ie has learned that the drug was reported to the National Drugs Advisory Board (NDAB) by mothers who suspected it had led to abnormalities in their children.
“Between 1976-1980 five reports of adverse reactions associated with use of Duogynon were received by the National Drugs Advisory Board (NDAB), a predecessor of the HPRA, describing suspected congenital abnormalities, with very limited information available in relation to these reports,” the Health Products Regulatory Authority (HPRA) said.
The company behind the pills, which operated a plant in Rathdrum Co Wicklow, has now been taken over by pharmaceutical giant Bayer.
Bayer has consistently denied that the drug had any role to play in children being born with abnormalities and did so again in a statement to this website which said:
"UK litigation in respect of Primodos, against Schering (which is now owned by Bayer), ended in 1982 when the claimants' legal team, with the approval of the court, decided to discontinue the litigation on the grounds that there was no realistic possibility of showing that Primodos caused the congenital abnormalities alleged.
“Based on the facts and on the law, Bayer does not accept that Primodos was responsible for causing congenital abnormalities.”
In 1975 the Drugs Advisory Board issued a warning to doctors urging them to discontinue use of hormonal pregnancy tests.
“There has been no assessment of the safety for use of such preparations for this purpose and such a use has not been accepted by the Board,” the letter read.
"There have been a few publications suggesting a possible relationship between the use of these preparations for such a purpose and the subsequent birth of offspring with congenital abnormalities.
Although there was a lack of “strong evidence” linking the drug to birth defects it “would be wiser to avoid the use of oestrogen progestogen preparations for this purpose since a firm statement of safety cannot be given" the notice said.
However, chair of the Association for Children Damaged by Hormone Pregnancy Tests in the UK, Marie Lyon told Independent.ie that the drug was still prescribed in high numbers after this letter.
HPRA has said it does not have information on how many women may have used the drug to test for pregnancy.
Ms Lyon's own daughter Sarah was born 47 years ago with one of her arms not fully formed and Ms Lyon is convinced that this occurred due to her use of Primodos, which her doctor gave her to find out if she was expecting.
She has been campaigning, along with other families, for years in a bid to secure an apology from the manufacturer.
"The next step really is a [UK] Government expert group looking at the evidence and my hope is that once the Sky documentary and they will realise the amount of evidence that we have and the inquiry will move forward," she said.
"To see now that our Government knew was a shock," she said.
"Because there was a noninvasive test available, there was no need for these drugs except of course they made money," she added.
Ms Lyon said she was been bowled over by the number of people worldwide who have gotten in touch now that the drug is back in the headlines again.
Promidos: The forgotten drug scandal airs Wednesday 22 March at 9pm on Sky News