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Debendox

Volume 978: debated on Monday 4 February 1980

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asked the Secretary of State for Social Services (1) pursuant to his reply, 24 January to the right hon. Member for Stoke-on-Trent South, if, when the Committee on the Safety of Medicines considered the possible teratogenic effects of antihistamines in June 1978 and February 1979, it had held a specific and separate inquiry into the drug Debendox;(2) pursuant to his reply, 24 January to the right hon. Member for Stoke-on-Trent South, which particular reports he was referring to concerning cases of congenital abnormalities occurring in the children of women taking anti-histamines such as Debendox;(3) pursuant to his reply, 24 January to the right hon. Member for Stoke-on-Trent South, if, following the granting of a product licence of right to Debendox in 1972, the same rigorous testing of this drug has been undertaken similar to that of new drugs;(4) if he will make a statement giving his estimate of the safety of the drug Debendox;(5) pursuant to his reply, 24 January to the right hon. Member for Stoke-on-Trent South, if he will specify what research he was referring to which had not established any causal relationship between Debendox and congenital abnormalities; if special research has been conducted by the Committee on the Safety of Medicines; and if he considers that no further research is now necessary.

[pursuant to his reply, 31 January 1980]: The Committee on Safety of Medicines did specifically consider the safety of Debendox in 1978 and 1979. It examined the available evidence on the possible teratogenic effects of Debendox and similar preparations. It also took account of the advice of specialists in this field. The evidence included reports of the following studies:

  • (a) Unusual fetal malformations after antihistamines in early pregnancy—a study by the Department of Medical Genetics, St. Mary's hospital Manchester (BMJ—18 March 1978)
  • (b) Teratogenicity Testing in Humans: A Method Demonstrating Safety of Bendectin (Debendox in United Kingdom) in Humans—Richard W. Smithells and Sheila Sheppard 1978.
  • It was open to the Committee on Safety of Medicines to ask for further studies to be carried out following its review, but this was not considered necessary in the light of human experience gathered over many years and the fact that for this class of compounds it is known that the animal species usually used may be inappropriate and give misleading results.In the light of advice from the Committee on Safety of Medicines and my professional advisers, I am satisfied that a casual relationship between Debendox and congenital malformations has not been established and that there are no grounds for removing the product from the market, nor for commissioning further research at this stage. The committee will, of course, continue to monitor any reports on this and related medicines.However, in view of the right hon. Gentleman's concern I am asking the committee to look again at its advice and to confirm that there are still no grounds for removing the product from the market.
    Ordinary scale rateLong term scale rate
    Single householderMarried coupleSingle householderMarried coupleElectricity index*
    July 1974£8·40£13·65£10·40£16·35121·4
    December 1979£18·30£29·70£23·70£37·65309·0
    Percentage increase at November 1979 since July 1974117·9117·6127·9130·3154·5
    * Based on the electricity component of the retail price index as published by the Department of Employment.

    asked the Secretary of State for Social Services (1) if he will list all the proposed regulations intended to be made under the Social Security Bill and set out in guideline form in the notes on clauses, which, intransferring to regulations the present discretionary rules currently laid down and exercised by the Supplementary Benefits Commission, materially alter the effect of any rules, giving in each case the reason why such