Depo-Provera (Hansard, 11 April 1984)

§ Mr. Kenneth Clarke

The licensing authority has received the report of the panel of persons appointed to hear representations by Upjohn Ltd. against the provisional decision not to grant a licence for the longterm use of the injectable contraceptive Depo-Provera. I am grateful to the panel for its work in producing the report, which I am arranging to be published today. Copies have been placed in the Library of the House.

The panel has studied the evidence put before it. Its summary and conclusions are as follows: Depo-Provera offers an alternative and highly effective method of contraception and its mode of administration would make it uniquely valuable for some women. The evidence at present does not support suggestions of major or life-threatening risks to women using the drug. Depo-Provera has not been subject to good quality epidemiological research which has identified a number of such risks for the combined oral contraceptive pill. However, Depo-Provera does have a number of drawbacks. Side effects are common, especially disruption of the menstrual cycle, amenorrhoea or irregular or prolonged bleeding. These side effects can be unpleasant and distressing and, because of the long duration of action of the injection, are not readily reversible and have to be endured until the effects of the injection disappear. The uncertain time to return to fertility will be a disadvantage in some cases. We consider that some of the women of whom Depo-Provera might be most beneficial would be unable fully to appreciate the risk of side effects and reach an informed choice of the product as their preferred method of contraception. For others we believe that, given careful counselling appropriate to their individual needs, they could be helped to understand the nature and probability of possible side effects and give their consent to treatment. We do not regard language difficulties as insuperable. Problems of consent, together with those of possible side effects, lead us to agree with the CSM that Depo-Provera, if licensed for long term use, should not be regarded as a contraceptive agent of first choice. A range of other contraceptive methods is available which, though in some cases marginally less effective or carrying risks clinically more serious, have been more thoroughly researched in clinical use. We would regard these as more suitable for the majority of women who might find this product's potential side effects disagreeable and the problems of reversing them unsatisfactory even though they had initially consented to treatment with Depo-Provera. We were, in fact, told by family planning experts that the number of women choosing this method of contraception in the United Kingdom would probably be small. Since our remit is to make findings of fact, we make no positive recommendations on licensing. However, we conclude that the long term use of Depo-Provera would be a useful method of contraception for women for whom other contraceptives are contraindicated, cause side effects or are otherwise unsuitable and who are seeking long-term contraception, provided they understand and accept the risks of side effects and uncertain delay in return to fertility. None of the evidence presented to us confirms suggestions of major life-threatening long-term risks but we recommend that, if a licence for long-term use is granted, the Licensing Authority should ensure that long-term research on the effects on women using the drug in this country is carried out".

The panel also advised that if the product were licensed the company should produce an information leaflet for doctors to give to patients, and should insert in its product literature a reminder to doctors of the importance of patient counselling.

We consider that the panel's report and findings fully justify our original reluctance to license the product on the basis then requested. In particular, the report underlines the importance of patient consent to the use of this drug. The report has clarified the issues and recommended a number of additional important safeguards if a product licence were now granted for long term use. Therefore we have decided to grant a product licence for the long-term use of Depo-Provera as a contraceptive subject to the warnings suggested by the panel on the categories of 283W patients for whom the product can be prescribed. We also propose to exercise our powers to approve all advertising for the product. This means that all advertisements will require prior clearance by the Licensing Authority. The company has indicated that it will accept the panel's suggestions relating to patient information leaflets and to research into the long-term effects of the drug.

The chief medical officers of the health departments of the United Kingdom will also be writing to all doctors to emphasise that the product is recommended for use only where no other contraceptive method is suitable. They will underline the importance of patient counselling and advise that the drug should be prescribed only to patients who are aware of and understand the purpose of the treatment and its possible side effects.

I am studying proposals made by the panel relating to the procedure at any future hearing of this kind.