§ Sir Dudley Smithasked the Secretary of State for Social Services what were the numbers of adverse reactions received in the years 1977 to 1984 for each of the licensed benzodiazepine products; and if any of the benzodiazepine products that will remain available for prescription on the National Health Service present adverse reaction problems not reported in other benzodiazepine products which are included on the list of drugs no longer prescribable on the National Health Service.
§ Mr. Kenneth ClarkeThe information requested relating to licensed benzodiazepine medicinal products is set out in the table. It is important to note that an adverse reaction report to the Committee on Safety of Medicines does not necessarily demonstrate a causal relationship between the reaction and the medicine concerned.
Some benzodiazepine products that will remain available in the National Health Service after 1 April 1985 have been suspected of adverse reactions which have not been reported for products that will not be so available. However, it should be borne in mind that the number and type of adverse reactions associated with a medicine depend in part on its licensed indications and volume of prescribing. The fact that a medicine may have been the subject of more or different adverse reactions reports than others does not necessarily mean that it is less safe than the others. The Committee on Safety of Medicines has 445W advised that when used in accordance with its respective data sheets the benefits of benzodiazepines outweigh their risks.
Reports of suspected adverse reactions to benzodiazepine drugs Drug 1977 1978 1979 1980 1981 1982 1983 1984 Alprazolam — — — — — — 57 43 Bromazepam — — — — — 1 14 11 Chlor Azepoxide 7 11 6 4 4 6 2 3 Clobazam — — 44 37 19 16 16 21 Clonazepam 9 6 — 2 — 3 3 6 Diazepam 33 53 25 18 11 30 18 17 Flunitrazep — — — — — 3 13 10 Flurazepam 24 31 10 13 8 6 2 3 Ketazolam — — — 10 2 4 2 1 Loprazolam Mesylate — — — — — — — 5 Lorazepam 43 36 29 31 24 24 35 20 Lormetazepam — — — — 5 8 15 12 Medazepam 2 2 2 1 — 1 — — Midazolam Hydrochloride — — — — — — 7 30 Nitrazepam 16 12 8 13 10 5 6 2 Oxazepam 4 5 — 4 1 2 — 1 Potassium Clorazepate 25 13 19 13 7 6 5 9 Prazepam — — — — — 3 15 2 Temazepam 2 31 25 35 26 21 23 27 Triazolam — — 50 51 48 87 41 20