Vol. 547 No. 1
693 Mr. Lawlor asked the Minister for Health and Children if, further to parliamentary Question No. 157 of 6 March 2001, he has asked the board to review the matter in view of additional information which has become available. [2801/02]
It is the policy of the Irish Medicine Board, IMB, to review the safety of all authorised medicinal products on an ongoing basis.
In keeping with this policy, the IMB in collaboration with its European counterparts has continually, monitored the safety profile of this medicinal product in order to identify any emerging safety issues and to take any appropriate regulatory action. To facilitate this monitoring process, the IMB has actively encouraged healthcare professionals to report all suspected adverse drug reactions, ADRs, associated with use of this medicinal product.
To date, the IMB has received 145 cases of suspected adverse drug reactions, ADRs, occurring during treatment. The majority of ADRs reported were in keeping with the types of reactions known to occur with this product. These reports consisted mainly of agitation, anxiety, dizziness, insomnia, tremor, nausea, pruritis – itching – rash and headache.
Two patients are reported to have died during treatment, but in neither case is this medicinal product considered to have caused their deaths. It should be noted that this product is estimated to have been used in approximately 33,000 patients in Ireland and in over 28 million patients world-wide.
In addition to encouraging reporting of suspected ADRs, the IMB has reminded healthcare professionals on a number of occasions of the prescribing information and published updated information in the Drug Safety Newsletter, December 2000 and April 2001, and in an article in MIMS, July 2001. Following one of the reviews of the world-wide safety data during 2001, the IMB in association with its European counterparts implemented regulatory action to strengthen the product information to minimise the risk of adverse reactions in particular, seizure.
This medicinal product will remain under review both at a national and European level and the Irish Medicines Board will take any further regulatory action considered appropriate.
