HC Deb 28 February 1978 vol 945 cc206-7W
Mr. Ashley

asked the Secretary of State for Social Services if he will now hold a full inquiry into the use of primodos and other drugs used in hormone pregnancy tests to examine when the first warnings of any dangers were reported; what steps were taken by his Department or the appropriate delegated medical authority; how many children may have been damaged by these drugs; and what steps he is taking to ensure that no unnecessary risks are being taken by the use of these drugs.

Mr. Moyle,

pursuant to his reply (Official Report, 22nd February 1978; Vol. 944, c. 730.] gave the following information:

As my hon. Friend will be aware from replies to his letters and previous Questions, a study reported in May 1967 suggested that hormonal pregnancy tests were 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 thought that the findings of the original study should be published. In 1969 the Committee began a pilot scheme for a long-term study of congenital abnormalities. By 1975 the preliminary findings of this study also suggested an association between hormonal pregnancy tests and nonspecific congenital abnormalities. These findings were confirmed in 1977. In 1975 pregnancy testing was removed from the premitted indications in the product licences, and in June of that year the Committee on Safety of Medicines warned all doctors of the possible hazard. The manufacturers included an appropriate warning in their product literature. In November 1977 the Committee issued a reminder to doctors, following the publication of the further results of the study. Primodos has since been removed from the market. Only one of the products referred to in the 1975 warning now remains on the market. This product, however, has various gynaecological uses, including that of contraception, and is a prescription-only product. The data sheet for it carries a warning that it should not be used in pregnancy.

It has not been proved that any of the drugs used as hormonal pregnancy tests in fact caused foetal damage. The study showed only a statistically significant difference between the number of malformed babies born to mothers who have taken the drugs when compared with controls. A calculation of the possible numbers of malformations due to the drugs cannot be made using the data available, which are derived from study of a selected sample. A new retrospective study to establish a cause and effect relationship would not be practicable; and since the drugs are no longer recommended for this purpose no prospective study can be undertaken. I have looked carefully into this matter, and I am advised it is not possible for further scientific inquiry to produce any meaningful results.