§ Mr. Simon HughesTo ask the Secretary of State for Health if the Licensing Authority, the Medicines Control Agency, the Medicines Division of the Department of Health or the Committee on Safety of Medicines have sought to prevent publication in peer-reviewed journals of information derived from yellow card data. [27351]
§ Mr. MaloneYes. Permission to publish information derived from yellow card data might be refused if it were considered that inappropriate use was being made of the data.
§ Mr. HughesTo ask the Secretary of State for Health if he will list all legal actions relating to the anti-depressant Mianserin in which the Licensing Authority or Committee on Safety of Medicines has been involved; and for each action if he will indicate whether the Licensing Authority or the CSM initiated the action, what was the legal basis of the action, what was the outcome and what were the legal costs incurred by the Licensing Authority or the CSM. [27352]
§ Mr. MaloneThe Licensing Authority, the Medicines Commission and the Committee on Safety of Medicines were involved in judicial review proceedings in connection with Mianserin in 1988 and 1989. The actions were initiated by the pharmaceutical company Organon Laboratories Ltd. in 1988 under section 107 of the Medicines Act 1968 and included applications for several interim orders between 20 December 1988 and 3 January 1989, prior to judicial review proceedings which took place in February 1989. Two applications for review were sought by Organon. The Licensing Authority lost the case on appeal in January 1990. Details of the legal costs are no longer held.
§ Mr. HughesTo ask the Secretary of State for Health if he will list all legal actions relating to Triazolam in which the Licensing Authority or the Committee on Safety of Medicines has been involved; and for each action if he will indicate whether the Licensing Authority or CSM initiated the action, what was the legal basis of the action, what was the outcome and what were the legal costs incurred by the Licensing Authority or CSM. [27353]
§ Mr. MaloneThe Licensing Authority is currently involved in judicial review proceedings in connection with Triazolam. The action was initiated by Upjohn Ltd. in 1993 under section 107 of the Medicines Act 1968. The case has not yet been concluded.
§ Mr. HughesTo ask the Secretary of State for Health if he will list the members of the pharmacovigilance subcommittee of the Committee on Safety of Medicines for the period from 1 January 1996. [27363]
§ Mr. MaloneThe membership of the sub-committee on pharmacovigilance is as follows:
- Professor A. Breckenridge (Chairman): professor of clinical pharmacology, Liverpool university
509 - Professor Darbyshire OBE: head of the Medical Research Council's HIV clinical trials centre, University college London medical school
- Dr. K. Beard: consultant physician in geriatric medicine, the Victoria infirmary, Glasgow
- Ms A Lee: principal pharmacist, drugs and poisons information
- centre, regional drugs and therapeutics centre, Newcastle
- Dr. T. MacDonald: senior lecturer, department of clinical pharmacology, Dundee university
- Professor K. MacPherson: professor of public health epidemiology, London school of hygiene and tropical medicine
- Dr. M. Pirmohamed: lecturer in clinical pharmacology and therapeutics Liverpool university
- Professor L. Ramsay: consultant physician at Hallamshire hospital and professor of clinical pharmacology and therapeutics, Sheffield university.
§ Mr. HughesTo ask the Secretary of State for Health if he will list those medicines whose licence has been(a) suspended, (b) revoked by the Licensing Authority or (c) withdrawn by the licence holder as a result of information from the yellow card system indicating the year in which the change in licence took place; who prompted the action; and what were the adverse effects identified by the yellow card system. [20505]
§ Mr. Malone[holding answer 21 March 1996]: Information about the safety of medicines is obtained from numerous sources of which the United Kingdom's yellow card scheme is only one. It is unusual for licensed medicines to be withdrawn from the market solely on the basis of information from yellow cards.
The information shown in the table lists those medicines licensed and marketed in the UK after the Medicines Act 1968 came into effect whose licence has subsequently been (a) suspended or (b) revoked by the Licensing Authority, or (c) withdrawn by the licence holder, as a result of information from the yellow card scheme.
The table does not include those medicines whose licence was suspended, revoked or withdrawn before the product was marketed in the UK. Nor does it include medicines which were granted a product licence of right when the Medicines Act 1968 came into force, or those with safety hazards identified primarily through other sources of information such as spontaneous adverse drug reaction schemes outside the UK.
510W
Brand name (drug substance) Year action taken1 Major safety concerns (a) Medicines whose licence has been suspended by the Licensing Authority Opren (benoxaprofen) 1982 Hepatotoxicity, serious skin reactions Flosint (indoprofen) 1983 Gastrointestinal toxicity, multi-system toxicity (b) Medicines whose licence has been revoked by the Licensing Authority Zomax (zomepirac) 1983 Anaphylaxis, renal failure (c) Medicines whose licence was withdrawn by the licence holder Osmosin (indomethacin— 1983 Small intestinal perforations
Brand name (drug substance) Year action taken1 Major safety concerns modified release) Zelmid (zimeldine) 1983 Neuropathy, convulsions, hepatotoxicity Methrazone (feprazone) 1984 Serious skin reactions, multi-system toxicity Pe xid (perhexiline) 1985 Neuropathy, hepatotoxicity Mental (nomifensine) 1986 Haemolytic anaemia, renal failure Glauline eye drops 0.6 per cent. (metipranolol) 1990 Uveitis Micturin (terodiline) 1991 Cardiac arrhythmias Roxiam (remoxipride) 1994 Aplastic anaemia 1 The year the action was taken relates to the year in which the product was removed from the market.