§ Mr. Ashleyasked the Secretary of State for Social Services (1) what investigations have been made into the safety of the drug Debendox; and if he will make a statement;
(2) what new factors led to the banning of over-the-counter sales of the drug Debendox and its issue on prescription only;
(3) if Debendox is a drug which was granted a produce licence of right.
§ Sir George YoungDebendox was granted a product licence of right in 1972. The Committee on Safety of Medicines considered the possible teratogenic effects of anti-histamines in June 1978 and February 1979, especially those such as Debendox which were prescribed specifically for pregnant women. This followed the publication of reports based on individual cases of congenital abnormalities occurring in the children of women taking these preparations. Research has, however, not established any causal relationship between the drug and congenital abnormalities and it is known that severe vomiting in pregnancy, for which Debendox is prescribed, may itself be associated with an increased incidence of congenital abnormality. Nevertheless, 337W the committee advised that, as a precaution to ensure that professional judgment is exercised, anti-histamine products which carried indications for use in pregnancy should be available only on prescription. In fact, Debendox had become legally a prescription-only medicine in 1978 for a different reason, that is because it contained dicyclomine.