Written Answers. - Drug Side Effects.

Question:

107 Dr. Upton asked the Minister for Health and Children if he has up-to-date information on the side effects of a drug (details supplied); if he has seen the latest ADR information on this drug; and if he will make a statement on the matter. [10375/00]

I have recently received up-to-date information on the side effects of the drug concerned, including the latest ADR information on the drug from the Irish Medicines Board. The Irish Medicines Board actively monitors all available data on this drug, including reports of adverse reactions, which it reviews both internally with its own experts and with the experts of the other European regulatory agencies.

This drug was authorised in Ireland in 1983 for use in the "treatment of cystic and conglobate forms of acne vulgarus or in those forms of severe acne which have failed to respond or rapidly relapse following adequate courses of accepted therapy". Under the terms of the product authorisation, its availability is limited in that it must be prescribed and its use monitored by a consultant dermatologist.

The Irish Medicines Board and its experts have continuously reviewed the safety information regarding this drug and are of the opinion that the benefits of the drug to the patients outweigh the potential risks associated with its use. This position is in keeping with current opinion in other member states of the European Union.

In order to more fully evaluate the ongoing safety and efficacy of this drug in Ireland, the Irish Medicines Board has recently requested the company concerned to undertake a post-marketing surveillance programme on its the use in this country. This programme will be used to re-evaluate the benefit-risk assessment of the drug. All dermatology specialists have been asked to monitor each patient using the drug and this infor mation will be reviewed by the Irish Medicines Board and action taken, as appropriate.