HC Deb 04 June 1996 vol 278 cc386-7W
Mr. Simon Hughes

To ask the Secretary of State for Health if he will list for the calendar years(a) 1993, (b) 1994 and (c) 1995 the total number of fatal suspected adverse drug reactions reported to the Committee on Safety of Medicines; and for each of the years if he will list the 10 drugs associated with the largest number of reported suspected fatal adverse reactions. [26291]

Mr. Malone

[holding answer 24 April 1996]: The information is shown in the tables.

Year Total number of fatal1reports
1993 471
1994 408
1995 476
1 Reports where the fatality was associated directly or indirectly with the adverse reaction.

The table provides information on the number of reports of suspected adverse drug reactions for fatal cases associated directly or indirectly with reactions reported to the Committee on Safety of Medicines by health professionals from 1993 to 1995. As the scheme is voluntary, not all adverse reactions are reported. A report of a suspected adverse drug reaction does not necessarily mean that it was caused by the drug cited; other factors may have contributed. Comparisons between different drugs may be misleading because many factors influence reporting, including the level of usage of a medicine, the length of time it has been on the market and whether there has been significant media coverage relating to its use.

Drug substances most frequently associated with fatal reactions in 1993 Drug substances most frequently associated with fatal reactions in 1994 Drug substances most frequently associated with fatal reactions in 1995
Drug substance Number of reports Drug substance Number of reports Drug substance Number of reports
1 = Clozapine 32 1 = Clozapine 28 1. Clozapine 34
1 = Flosequinan2 32 1 = Diclofenac 28 2. Diclofenac 22
3. Virus Influenza 17 3. Fluoxetine 12 3. Ethinyloestradiol 21
4. Fluoxetine 16 4 = Cyproterone 9 4. Fluoxetine 15
5. Streptokinase 15 4 = Strepokinase 9 5 = Sertraline 12
6 = Ethinlyoestradiol 14 4 = Finasteride 9 5 = Paroxetine 12
6 = Diclofenac 14 7 = Paroxetine 7 7 = Amiodarone 10
8. Moclobemide 12 7 = Ethinyloestradiol 7 8 = Nicorandil 9
9. Cyproterone 9 9 = Virus influenza 6 8 = Ibuprofen 9
10. Methotrexate 8 9 = Amiodarone 6 10 = Thioridazine 8
9 = Misoprostol 6 10 = Gestodene 8
9 = Ciprofloxacin 6 10 = Levonorgestrel 8
9 = Lithium 6 10 = Methotrexate 8
1 Reports where the fatality was associated directly or indirectly with the adverse reaction.
2 This product was withdrawn from the market in 1993 because of concerns regarding increased mortality associated with its use. Some of the reports associated with the drug substances presented concern products containing multiple active ingredients. The figures provided are for the number of suspected adverse drug reactions where the reaction began in the year specified.