Medicines (Safety) (Hansard, 10 May 1996)

§ Mr. Simon Hughes
To ask the Secretary of State for Health if he will list the occasions during 1994 on which(a) the Licensing Authority, (b) the Medicine Control Agency and (c) the Committee on Safety of Medicines have taken legal action with respect to matters relating to 281W the Medicines Act 1968; and how many injunctions have been sought during that period relating to material relating to the efficacy or safety of medicines. [28137]

§ Mr. Malone
A list of those occasions will be placed in the Library.
One injunction was sought with the consent of the Attorney-General and granted in 1994: to stop the illegal promotion and sale of gamma hydroxybutyrate, an unlicensed medical product known to be used as a drug of abuse.

§ Mr. Hughes
To ask the Secretary of State for Health if he will list for each occasion that the chairman of the Committee on Safety of Medicines has sent "Dear Doctor" letters to United Kingdom doctors, what regulatory action accompanied the letter, the date of the letter and the date of the licensing action. [28139]

§ Mr. Malone
I refer the hon. Member to the reply I gave him on 9 May. The "Dear doctor" letters sent out by the chairman of the Committee on Safety of Medicines prior to 1980 are shown in the table.

Subject Date of letter Products containing the following drug substance(s)

Establishment of the Committee on Dental and Surgical Materials—advice on reporting of adverse reactions 23 January 1979 No safety issue

Mortality among women using oral contraceptives 6 October 1977 Combined oral contraceptives

Phenformin and lactic acidosis 7 September 1977 Phenformin

Sub-acute myelo-optic neuropathy with clioquinol; May 1973 Clioquinol

Vaginal adenocarcinoma with stilboestrol; May 1973 Stilboestrol

Safety of local anaesthetics containing noradrenaline, use in patients on antidepressants; May 1973 Local anaesthetics (preparations containing 1:25,000 noradrenaline), Tricyclic antidepressants

Anticonvulsants and congenital abnormalities May 1973 Anticonvulsants including primidone, phenobarbitone and phenytoin

Combined oral contraceptives and pulmonary embolism May 1973 Oral contraceptives (>50 micrograms oestrogen)

Subject	Date of letter	Products containing the following drug substance(s)
Establishment of the Committee on Dental and Surgical Materials—advice on reporting of adverse reactions	23 January 1979	No safety issue
Mortality among women using oral contraceptives	6 October 1977	Combined oral contraceptives
Phenformin and lactic acidosis	7 September 1977	Phenformin
Sub-acute myelo-optic neuropathy with clioquinol;	May 1973	Clioquinol
Vaginal adenocarcinoma with stilboestrol;	May 1973	Stilboestrol
Safety of local anaesthetics containing noradrenaline, use in patients on antidepressants;	May 1973	Local anaesthetics (preparations containing 1:25,000 noradrenaline), Tricyclic antidepressants
Anticonvulsants and congenital abnormalities	May 1973	Anticonvulsants including primidone, phenobarbitone and phenytoin
Combined oral contraceptives and pulmonary embolism	May 1973	Oral contraceptives (>50 micrograms oestrogen)