§ Mr. Ashleyasked the Secretary of State for Social Services (1) if the Committee on Safety of Medicines has been informed which EEC countries no longer use hormone pregnancy test drugs; and if he will publish the date when each country stopped doing so;
(2) if the Committee on Safety of Medicines has consulted with the American experts on their experience on hormone pregnancy test drugs; and if he will give the results of the consultation, if any;
232W(3) it the Committee on Safety of Medicines has received any advice from the World Health Organisation on hormone pregnancy test drugs; when it received it; and what it said.
§ Mr. MoyleThe Committee on Safety of Medicines received information from the World Health Organisation—WHO—in February 1975 that hormone pregnancy tests had been withdrawn from the market in Australia and in April 1975 that, following consideration of a new drug application, approval for hormone pregnancy test drugs had been withdrawn in the United States of America. A major article in a WHO Information Bulletin in 1977 reviewed the background literature and stated that the promotion of progestational hormones for pregnancy diagnosis had been prohibited by a number of national drug regulatory authorities. Subsequent WHO publications refer to the final results of the Committee on Safety of Medicines' own study "Maternal Drug Taking and Congenital Abnormalities" and the Belgian removal of pregnancy testing from the indications for these preparations.
Comprehensive information on the licensing in all EEC countries of preparations used for hormone pregnancy testing is not readily available.
The Committee on Safety of Medicines has consulted experts at Boston University Medical Centre who have recently published the results of a study of 50,000 pregnancies. These show no relationship between the use of sex hormones in general and congenital abnormalities.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether the hormone pregnancy test drugs have any advantages over the urine test as a method of establishing pregnancy; and what are the relative degrees of reliability of the result of both the hormone pregnancy test and the urine test for establishing pregnancy;
(2) how many hormone pregnancy test drugs have been prescribed from the time that the urine tests became available until the hormone pregnancy test drugs were finally taken off the market in 1978.
§ Mr. MoyleAt the time of their introduction, hormonal pregnancy tests provided a more simple, rapid and reliable 233W means of diagnosing pregnancy than the urine tests then available. Subsequently improved types of urine tests have been developed. The most widely used urine test at present is accurate in 98 per cent. of cases and I am advised that this is more reliable than a hormonal pregnancy test. Prescription data do not reveal the purposes for which a given drug was prescribed; as these hormonal products had a number of gynaecological uses, it is not possible to estimate figures of usage relating solely to pregnancy tests.