§ Mr. Carter-Jonesasked the Secretary of State for Social Services (1) if he will publish in the Official Report the new evidence published on the drug Depo-Provera which makes it safe for short-term and long-term use; why this drug has not been given a long-term licence previously; and if he will make a statement;
(2) how many yellow card cases he has now received regarding the drug Depo-Provera; if his Department will accept financial responsibility for proven suffering and damage from this drug; and if he will make a statement.
§ Dr. VaughanDepo-Provera has been licensed in the United Kingdom for use as a short-term contraceptive in limited circumstances since 1978. It was not granted a licence for long-term use at that time because of questions arising from research findings that the active ingredient, medroxyprogesterone acetate, could cause tumours in beagle bitches. An international conference has since concluded that the beagle bitch is not a valid model for the carcinogenicity testing of progesterones and other contraceptive steroids. The Department is aware of no new published evidence relating to the safety of Depo-Provera. Data which are under consideration in respect of the application for a licence for long-term use of the product as a contraceptive are treated as confidential for commercial reasons.
To date the Committee on Safety of Medicines has received 41 reports of suspected adverse reactions to Depo-Provera.
198WAs the law stands, liability and compensation for injury alleged to have been caused by treatment with any drug including Depo-Provera are matters solely for the parties concerned, that is, normally the patient, his or her doctor and the pharmaceutical company responsible. It would, therefore, be inappropriate for the Department to intervene.