HC Deb 09 June 1993 vol 226 cc262-3W
Mr. Oppenheim

To ask the Secretary of State for Health if she will make a statement on the availability of products containing triazolam in the United Kingdom.

Dr. Mawhinney

All licences for triazolam products, including the brand named Halcion, to Upjohn Limited are being revoked on 9 June 1993. Triazolam products, which were available for the treatment of insomnia between 1978 and 1991, will therefore remain withdrawn. On the advice of the Committee on Safety of Medicines, licences for Halcion were suspended in October 1991 on grounds of safety and all triazolam products were withdrawn from the market at that time, pending proceedings to revoke the licences.

The three bodies who have heard representations from Upjohn against the proposed revocation of the triazolam licences have given conflicting advice. The Committee on Safety of Medicines and the Medicines Commission were both concerned about the safety of triazolam and advised that the 0.25 mg product licences should be revoked but they differed as to whether or not the 0.125 mg licences should be revoked. In contrast, a panel of persons appointed by the licensing authority under the Medicines Act 1968 concluded that the benefits of both dose forms of triazolam outweigh the risks and appeared largely reassured by the revisions of the product information proposed by Upjohn.

The licensing authority has based its decision on consideration of the safety of triazolam. It has taken into account the views of each of the advisory bodies in reaching the decision and carefully considered the underlying reasons for the differences in the conclusions and advice received. The licensing authority has not accepted the conclusions of the panel and is not reassured of the safety of triazolam.

The licensing authority has examined measures alternative to revocation of the licences for triazolam but has concluded that restrictions in the dose, duration of treatment or availability of triazolam would not provide adequate safeguards against its hazards in normal use.

The first concern must be for patients. Because we are not satisfied as to the safety of triazolam, we believe it is right to be cautious.

In summary, the licensing authority has considered the basis of the panel's conclusions carefully but remains not reassured of the safety of the triazolam products, and considers that the risks of triazolam outweigh its benefits in normal use.

Copies of the report of the panel of persons appointed and detailed reasons for the licensing authority's decision are available in the Library.

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