HC Deb 27 April 1978 vol 948 cc628-30W
Mr. Ashley

asked the Secretary of State for Social Services (1) if, pursuant to his reply of 10th April 1978 to the hon. Member for Stoke-on-Trent, South, he will now ask all the companies producing hormone pregnancy test drugs to meet him to discuss the steps they have taken to ensure that such drugs conform to the advice tendered by the Committee on Safety of Medicines;

(2) if, pursuant to his reply of 10th April to the hon. Member for Stoke-on-Trent, South, he will state if the Committee on Safety of Medicines, acting as licensing authority to him, advised that measures should be taken to ensure that warnings were issued in all promotional literature for hormone pregnancy test drugs about possible hazards to pregnancy; and why such warnings were not issued previously in view of existing medical knowledge;

(3) why no warnings of the dangers of hormone pregnancy test drugs were issued by his department after the first reports of the dangers of such drugs;

(4) pursuant to his reply to the hon. Member for Stoke-on-Trent, South, on 13th December 1977, what further discussions he has had with the manufacturers of Primodos and other hormone pregnancy test drugs; and what conclusions he reached.

Mr. Moyle

A report in 1967 suggested that hormonal pregnancy tests might be associated with neural tube defects. Other studies did not confirm these findings and the initial report was open to criticism on scientific grounds. Nevertheless, the Committee on Safety of Drugs suggested that it should be published to alert the profession. The Committee did not feel justified in taking further action itself without stronger evidence. It had already decided to carry out, as soon as competing demands allowed, its own wide-ranging survey of the possible adverse effects of drugs taken in pregnancy. When the preliminary findings of this study became available in 1975, they indicated a statistical relationship between hormonal pregnancy tests and non-specific congenital abnormalities.

The United Kingdom Health Ministers acting as the licensing authority were then advised by the Committee on Safety of Medicines that measures should be taken to ensure that indications for pregnancy testing were no longer included in the licences for such products and to require the insertion in all promotional literature of a warning about the possible hazard in pregnancy. The licensing authority acted upon the Committee's advice. Warnings were also issued by the Committee to all doctors.

Since my reply to my hon. Friend on 13th December 1977, I have had no further discussions with the manufacturers of Primodos or other hormone pregnancy test drugs. I understand that all those companies concerned took the measures required by the licensing authority. I therefore see no need to meet the companies to discuss this matter.—[Vol. 941, c. 152.]