Vol. 546 No. 1
122 Dr. Upton asked the Minister for Health and Children the position regarding research of his Department and the Irish Medicines Board to the safety of a drug (details supplied); and if he will make a statement on the matter. [31350/01]
The Irish Medicines Board – IMB – routinely monitors the safety of all medicinal products through review and evaluation of suspected adverse drug reaction – ADR – reports notified in association with their use. These reports together with additional information from other sources – foreign reports, literature publications, study reports etc. – provide a basis for any regulatory action deemed necessary to allow a medicinal product to continue to be used, with an acceptable margin of safety, in Ireland.
As well as these routine methods to review the safety profile of the drug concerned and identify any emerging safety issues associated with its use, the human medicines advisory committee – HMAC – of the IMB recommended that a post-marketing surveillance, PMS, programme for the drug concerned should be undertaken in Ireland. This PMS programme was initiated in August 1999 and is ongoing. Information collated in respect of 378 patients treated with the drug concerned has not given rise to any new safety concerns or impacted on the IMB's previous assessment of the risk of development of symptoms of depression as currently set out in the product information.
123 Dr. Upton asked the Minister for Health and Children his views on recent deaths following use of an anti-malarial drug; and if he will make a statement on the matter. [31352/01]
To date, the Irish Medicines Board – IMB – has not received any reports of fatalities suspected in association with use of the anti-malarial medicine referred to by the Deputy. The IMB is however, aware of recent newspaper reports referring to a fatality in a 27 year old Irish man following treatment with the drug concerned. As details of this case have not as yet been provided to the IMB by the coroner, it is not possible to comment further on this specific case at this stage.
