Seán Barrett
Ceist:39 Mr. Barrett asked the Minister for Health if he has satisfied himself with the safety of the drug halcion which is widely available throughout the State; and if he will make a statement on the matter.
Written Answers. - Safety of Halcion Drug.
John Bruton
Ceist:56 Mr. J. Bruton asked the Minister for Health if he has satisfied himself with the safety of the drug halcion which is widely available throughout the State; and if he will make a statement on the matter.
Godfrey Timmins
Ceist:57 Mr. Timmins asked the Minister for Health if he has satisfied himself with the safety of the drug halcion which is widely available throughout the State; and if he will make a statement on the matter.
I propose to take Questions Nos. 102, 103 and 104 together.
This drug has been available in Ireland since 1979. It is a prescription-only medicine and its use is therefore subject to medical supervision. It is recommended for short term use only.
I am aware of the concerns expressed in the past regarding halcion. Following the publicity in 1991 regarding this drug the National Drugs Advisory Board carried out a special review of the situation but it did not conclude that the product should be withdrawn. The board continues to maintain ongoing monitoring of this drug and, indeed, of all benzodiazepine drugs of this class on the Irish market.
The committee for Proprietary Medicinal Products of the European Communities, which includes representatives from the National Drugs Advisory Board, also examined the position in 1991. The report of that examination did not indicate that the drug should be withdrawn, but stressed the appropriate safeguard measures including the setting of maximum dosage levels, precise indications for prescribing and the importance of short term usage.
In the light of the opinions of both the National Drugs Advisory Board, and the Committee for Proprietary Medicinal Products, I do not propose to take any action modifying the current authorisation for this product.
However, I would stress that this drug is intended for short term use only. In accordance with the advice of the Committee for Proprietary Medicinal Products, it should not be used for more than ten days and treatment thereafter requires a complete re-evaluation of therapy. Patients in any doubt should consult with their medical practitioners.