§ Mr. Ashleyasked the Secretary of State for Social Services (1) how many prescriptions have been issued for Debendox since it went on prescription;
(2) how many prescriptions were issued for Debendox in the last year before it was withdrawn or for which information is available and since it was withdrawn by the manufacturers.
§ Mr. Kenneth ClarkeInformation on numbers of prescriptions for individual drugs is usually confidential because of its commercial value, but the manufacturers of Debendox ceased producing it in June 1983, so information on it is no longer of value. The drug was introduced to the United Kingdom market in 1957. An estimated 3,131,000 prescriptions for Debendox were dispensed in the family practitioner services in England between January 1970 (the date from which the figures are available) and September 1983 (the latest period for which estimates are available). An estimated 84,400 of those prescriptions were dispensed from July 1982 to June 1983 inclusive, and an estimated 1,400 prescriptions from July to September 1983 inclusive.
These estimates are based on a sampling exercise of one in 200 prescriptions and cannot therefore be entirely reliable for short periods. They do not include usage in hospitals because we do not collect this detailed local information centrally.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) whether the Committee on Safety of Medicines in its investigations of Debendox considered the findings of (a) Hendrickx's 1982 study of the effect of Bendictin (Debendox in the United Kingdom) on monkey embryos, (b) Roll and Mattiaschk's unpublished study on the effect of a component of Benedictin on mice and rats, (c) Hassell and Horrigan's 1982 study examining the teratozive effects on Bendictin on mice, (d) Bass's 1979 review of a collaborative perinatal study on the level of diaphragmatic hernias, (e) Golding's 1983 study on the level of cleft lips and palates, (f) Eskenazi and Bracken's 1982 study on the level of pylonic stenosis and heart valves and (g) Gibson's 1981 study on the level of genital tract abnormalities;
(2) on how many occasions the Committee on Safety of Medicines investigated the safety of Debendox; what were its separate conclusions; when was the last time it investigated the drug; and what were its conclusion then.
§ Mr. Kenneth ClarkeThe Committee on Safety of Medicines (CSM) considered the safety of Debendox in June 1978, February 1979, March and November 1980, February, April and May 1982, and February 1983. On each occasion the committee concluded that there was no scientifically acceptable evidence that Debendox caused harm to the foetus.
334WBefore reaching this conclusion, the CSM considered a substantial amount of scientific evidence relating to Debendox, including the studies by Hendrickx, by Roll and Mattiaschk, and by Eskenazi and Bracken.