§ Mr. Wigley
asked the Secretary of State for Social Services (1) what notification has been given to medical practitioners concerning the dangers of adverse reaction which arise from use of the drug Halcion, Triazolam; whether any special scrutiny of the patients using this drug has been set up; whether he has considered restricting the availability of this drug; and if he will make a statement;
(2) whether his Department has received advice from the Committee for Proprietary Medicinal Products of the European Community under directive 75/319/EC, in relation to the market authorisation for the drug Halcion;
(3) what information he has as to which overseas countries have banned the use of the drug Halcion, Triazolam.
§ Mr. Geoffrey Finsberg
I refer the hon. Member to my replies to the right hon. Member for Stoke on Trent, South (Mr. Ashley) on 4 May—[Vol. 23, c.31–33]—and 27 May—[Vol. 24, c. 390–91.] Since these replies were given, the matter has been kept under review by the Committee on Safety of Medicines, which had received by January of this year 222 adverse reaction reports associated with triazolam. I am aware of no scientific evidence either from this or other countries, to justify action to limit the availability of this drug. I understand that the company concerned is currently undertaking a study of triazolam in comparison with another drug of this group.
Possible side effects of triazolam have been discussed on several occasions since 1979 by the Committee for Proprietary Medicinal Products, which considered that a dose of 0.5 mg of the drug produced undesirable effects similar to those caused by the higher doses of other medicinal products in the short acting members of the benzodiazepine group. The maximum recommended dose in this country is 0.25 mg.
I understand that only the Netherlands has withdrawn Triazolam from use. Luxembourg suspended the drug for a short period while the reports from the Netherlands were investigated and has subsequently re-instated it.