§ Mrs. Renée Shortasked the Secretary of State for Social Services (1) what advice the Committee on Safety of Medicines gives to doctors concerning the prescribing of the pregnancy-testing drug Primodos;
(2) what adverse reactions have been reported connected with the pregnancy-testing drug Primodos;
(3) if he is satisfied with the safety aspects of the pregnancy-testing drug Primodos.
§ Mr. Kenneth Clarke[pursuant to his reply, 12 July 1982, c. 291–92]: The indication for pregnancy-testing was removed from the product licences of a number of hormonal preparations, including Primodos, in 1975, because there was evidence of a possible association between taking these products and an increased incidence of congenital abnormalities. The Committee on Safety of Medicines—CSM—advised all doctors in June of that year that they should no longer be used for pregnancy-testing. No hormonal preparation is currently licensed for this indication. The product licence for Primodos expired in 1978 and it is therefore no longer marketed in the United Kingdom.
The CSM has received 52 reports of adverse reactions suspected to have been associated with Primodos. These included reports of congenital malformations and of vascular disorders.