§ Mrs. Renée Short
asked the Secretary of State for Social Services (1) if he is satisfied that adequate tests have been carried out to ensure that the taking of Proluton Depot during pregnancy will not lead to the birth of abnormal babies;
(2) if he is satisfied with the safety of taking Proluton Depot during pregnancy; what plans he has to prohibit the prescribing of Proluton Depot to pregnant women pending further investigations into its safety; and if he will make a statement.
§ Mr. Patrick Jenkin
Because Proluton was already on the market when licensing began in 1971, it was automatically granted a product licence of right. The manufacturers were not, therefore, required to provide the data which are now obligatory in respect of new products. This product is available only on prescription. The data sheet issued to doctors advises that many medicinal products, including female sex hormones, have been suspected of being capable of affecting the normal development of a child in the early stages of pregnancy; that for no medicinal product can a teratogenic activity be excluded with absolute certainty; and that, following the general principle of avoiding inessential drugs in pregnancy, Proluton Depot should be used to maintain pregnancy only if it is strictly indicated—that is, if there is an urgent desire to have a child. The report recently published inThe Practitioner will be drawn to the attention of the Committee on Safety of Medicines, which will also continue to monitor any other reports of suspected adverse reactions. Pending any recommendations from the committee, I do not propose to take any action against the licence, nor to interfere with doctors' freedom to prescribe the product.