UK & World News
Primodos Row: Watchdog Took Years To Warn GPs
The Government medicines watchdog took years to warn doctors about a pregnancy test drug that may have caused deformities in babies in the womb, Sky News has learned.
The drug Primodos, a hormone pregnancy test, was prescribed by GPs across England in the 1960s and 70s - and was taken by 1.5 million British women.
But Sky News has found it was not licenced to be used in pregnancy after 1970 amid concerns about its effect on the foetus.
Freedom of Information Requests to the Medicines and Healthcare Products Regulatory Agency (MHRA) revealed letters were written to doctors - but not until five years later in 1975 when a warning was also placed on the packet.
Then called the Committee on Safety of Medicines, the watchdog warned GPs of concerns about "an increased incidence of congenital abnormalities" in babies born to women who took the drug.
They wrote: "On the present evidence, the Committee believe that it is possible that the use of these preparations for the diagnosis of pregnancy could on occasion lead to abnormalities of the foetus."
Even after this, thousands of prescriptions were given to women until 1977 when the Committee sent a second letter to GPs saying the association had been confirmed. After this prescriptions ceased.
However, the MHRA said in a statement: "We do not hold any such letters and are not aware that any were sent by the CSM about Primodos or hormone pregnancy tests at that time. Nor are we able to comment on whether a letter should have been sent."
For years campaigners with deformities allegedly caused by the drug have challenged the German drug company Shearing, now owned by Bayer, to accept responsibility. The company however insists no link has been shown.
Three years ago Sky News conducted an exclusive investigation speaking to retired researchers who originally raised concerns about the drug.
One of them, Dr Isobel Gal who conducted research at Queen Mary's Hospital for Children in Surrey, told Sky News how she spent a decade trying to persuade people of the link.
Documents seen by Sky News, that have been sealed in the National Archives for 30 years, show CSM officials admitted they made mistakes while rudely dismissing Ms Gal and her research.
They, along with other letters about the drug, were found by an alleged victim of Primodos, Nichola Walton, who suffers from stomach and spinal abnormalities.
She said: "They've covered so many things up so many times. So many victims have already passed.
"So many parents have buried their children and they've not been able to see the evidence. They've not been able to explain. I just think it is appalling."
In a statement Bayer, which took over Shering, told Sky News: "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."
They also said that any use of Primodos as a pregnancy test after 1970 would have been "off-label".