Film reveals how pregnancy drug could be the cause of birth defects
A controversial pregnancy-testing drug - at the centre of allegations of birth defects in the 1970s - was the subject of a safety warning from the Irish medicines' watchdog, it emerged yesterday.
The drug Primodos, marketed as Duogynon in Ireland, will be investigated in a Sky Atlantic TV documentary tonight.
The programme claims that new evidence has emerged in the form of files stored in archives for decades in Berlin showing concerns the drug could cause malformations.
A spokesman for the Health Products Regulatory Authority (HPRA), Ireland's medicines watchdog, said it had no information on the numbers in this country who may have used Duogynon for diagnosis of their pregnancies in the 1970s.
However, he said: "Duogynon was not an authorised medicinal product."
The Irish regulatory authority at the time, the National Drugs Advisory Board (NDAB), issued a warning letter to doctors about the use of hormonal pregnancy testing preparation.
"This letter reminded practitioners that these preparations had not been assessed by the NDAB and their use as a means of pregnancy testing had not been accepted by the NDAB.
"The letter also highlighted that these preparations should be avoided as a firm statement of safety could not be given and other more efficient methods of pregnancy testing were available."
He said the HPRA would advise anyone now who has any concerns about possible exposure to Duogynon in the 1970s to talk to their doctor.
Campaigners in the UK who have been fighting for compensation said it was now known that Primodos contained super-strength hormones that later would be used in the morning-after pill.
In 1967, a paediatrician in England found a high proportion of babies born with spina bifida had mothers who had taken hormonal pregnancy tests.
An attempt to bring the case to court by the alleged victims in 1982 collapsed and legal aid was withdrawn from 700 families who were suing the drug's manufacturer, Schering.
It was deemed unlikely they could prove a causal link. Schering is now owned by Bayer. It said the evidence of a link was "extremely weak" and it rejected any cover-up by Schering.