§ Mr. Alfred MorrisTo ask the Secretary of State for Health how many deaths linked to the use of sulphamethoxazole have been reported by doctors to the Committee on Safety of Medicines; what research the committee has undertaken into the number of unreported cases; what action has been taken; and if she will make a statement.
§ Mr. SackvilleSulphamethoxazole has not been available as a single constituent product since 1977. Prior to this time, no suspected adverse reactions with a fatal outcome were reported in association with Sulphamethoxazole alone. Since 1977, it has been available only as a multi-constituent product in combination with trimethoprim, as co-trimoxazole. The Committee on Safety of Medicines—CSM—has received 135 reports of deaths suspected to have been associated with the use of co-trimoxazole. Such reports do not necessarily mean that the drug was responsible. Co-trimoxazole has been very widely used. Some 87 million prescriptions have been dispensed since the drug was first marketed in the United Kingdom.
No specific research has been undertaken by the CSM with respect to under-reporting of suspected adverse reactions to co-trimoxazole.
Reports of serious and fatal adverse reactions to co-trimoxazole have been kept under review by the CSM. In July 1985 an article was published in "Current Problems", its regular drug safety bulletin, informing doctors of deaths, predominately due to blood dyscrasias and skin reactions, reported in association with co-trimoxazole. In addition, the data sheet for cotrimoxazole, produced by the manufacturer and authorised by the licensing authority, fully reflects its known side-effects.
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