§ Mr. Ashley
asked the Secretary of State for Social Services how many cases of deformed babies being born to women who took the drug Debendox during pregnancy have been reported to his Department since 1963; if he is satisfied that the numbers reported represent the actual total; and what steps he is taking to improve the reporting of adverse reactions to medical drugs.
§ Dr. Vaughan
[pursuant to his replies, 14 February 1980, c. 815, and 21 February, Vol. 979, c. 320]: In the period 1963 to 12 February 1980, the Department received a total of 108 reports of the birth of congenitally malformed babies to women who had been prescribed the drug Debendox during pregnancy. The number of reports submitted in each year was:
1963 — 1964 1 1965 1 1966 1 1967 2 1968 6 1969 10 1970 4 1971 1 1972 7 1973 7 1974 10 1975 7 1976 7 1977 16 1978 13 1979 11 1980 (to 12 February) 4
These figures need to be interpreted with caution. Congenital abnormalities are, unfortunately, not uncommon and occur spontaneously. It is known that severe and untreated nausea and vomiting in pregnancy is associated with a higher incidence of foetal abnormality than occurs in uncomplicated pregnancies. A direct cause-and-effect relationship between such abnormalities and Debendox —or other treatments of nausea and vomiting in pregnancy—cannot therefore be assumed.601W
This complex situation will obviously affect the doctor's decision whether to send a report in an individual case. In its earlier review the Committee on Safety of Medicines took account of these complicating factors and of the reports sent in by doctors up to that time.
I hope to make a statement in the near future about procedures for reporting adverse reactions to drugs.