§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will ask the Committee on Safety of Medicines to investigate claims that pregnant mothers are still using the hormone pregnancy test drug Primodos;
(2) what discussions he has had with Schering Chemicals about any damage to unborn babies caused by its product Primodos; and if he will discuss the future of this drug with the company if he has not already done so;
(3) what discussions he has had with the manufacturers of the hormone pregnancy test drug Primodos about the use of the drug and its withdrawal;
(4) if he is satisfied that doctors are now not prescribing the hormone pregnancy test drug Primodos following its withdrawal by the manufacturers.
§ Mr. MoylePrimodos was a hormonal preparation licensed for the treatment of secondary amenorrhea; I understand that it has not been promoted for pregnancy testing since 1969. Following evidence of a statistical association between its use and an increased incidence of congenital abnormality, the safety of the drug was discussed with the manufacturers. The issue of compensation was not raised since this is a matter for the parties concerned and not my Department nor the Committee on Safety of Medicines. In January 1978 the manufacturers advised the licensing authority that they had decided to discontinue marketing Primodos for commercial reasons.
The prescribing of a product for a particular purpose is always a matter for clinical judgment and the Committee on Safety of Medicines seeks to provide doctors with all relevant facts. In the case of Primodos, the Committee has published in the British Medical Journal two articles giving the full findings of the study on maternal drug use and congenital abnormality and has issued two warning leaflets in its adverse reactions series to advise doctors that hormonal tests for pregnancy should not be used. In addition the manufacturers have written to doctors to remind them of the same point. In the light of these warnings and other information available to them, doctors will have been in no doubt about the 392W proper use of Primodos. I should, of course, be happy to investigate any evidence my hon. Friend has that, despite what I have said, Primodos continues to be used for pregnancy testing.