§ Mr. Charles R. Morris
asked the Secretary of State for Social Services, further to his reply to the hon. Member for Eccles (Mr. Carter-Jones) Official Report, 22 July, column 201, what report he has received from the Committee on Safety of Medicines as to the safety of the contraceptive injection Depo Provera; if he will ensure that any adverse evidence is brought to the attention of those to whom the drug is prescribed; and if he will make a statement.
§ Sir George Young
On the first part of the right hon. Gentleman's question, I cannot add to my right hon. Friend's earlier reply to which he refers.
Information about the most commonly reported adverse effects to this product is available to doctors in the product data sheet. I should expect that a doctor would discuss possible side effects with his patient but the extent to which he does this is solely a matter for his clinical judgment.
§ Mr. Carter-Jones
asked the Secretary of State for Social Services (1) if he will indicate in the Official Report the contraindications and warnings contained on the data sheets regarding Depo Provera in 1965, 1970, 1975 and the current year; and if he will make a statement;
(2) if the Committee on Safety of Medicines followed up a report from a professor of obstetrics and his fellow consultants regarding a 20 per cent. severe adverse menstrual reaction to Depo Provera; whether such reactions would be reported in the adverse reactions of the Committee on Safety of Medicines; and if he will make a statement.
§ Mr. Patrick Jenkin
The current data sheet for Depo Provera gives the following contra-indications and warnings, which are unchanged from those publicised in 1975:—66WContra-indications: Depo Provera is contra-indicated in thrombophlebitis or history of pulmonary embolism and liver dysfunction or disease. It is also contra-indicated in known or suspected malignancy of breast or genital organs.Warnings: Whether administered alone or in combination with oestrogen, Depo Provera should not be employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital malignancy eliminated.
For products on the market before 1971 there was no legal requirement to prepare data sheets until 1973.
As my hon. Friend indicated in his reply to the hon. Member on 9 July—[Vol. 988, c. 199–200]—only four cases of suspected adverse reactions to Depo Provera have been reported to the Committee on Safety of Medicines by hospital medical staff, including one consultant. Reports of suspected adverse reactions, received from doctors but which no not refer to specific cases, are not normally included in the adverse reactions register for statistical purposes. The committee does not routinely follow up reports of suspected adverse reactions with further inquiries unless, in the opinion of their expert professional advisers, there are particular clinical reasons for doing so. All reports are, however, acknowledged and any specific questions raised by the reporter are answered.