Dáil Éireann Debate, Thursday - 6 February 2014
180. Deputy Seán Ó Fearghaíl asked the Minister for Health if his Department or the Health Service Executive or the Irish Medicines Board has a record of the number of persons who have conditions consistent with the negative side effects following the use of Lariam; and if he will make a statement on the matter. [5903/14]
Amharc ar fhreagraLariam, which contains the active ingredient mefloquine, is one of a range of medicines authorised for use in Ireland and in some 53 countries worldwide for the prevention and treatment of malaria, a life threatening disease from which some 600,000 people die each year.
Since Lariam was first licensed for use in Ireland in 1989, the Irish Medicines Board (IMB) has received 96 reports of suspected adverse reactions in association with its use. The majority of these reactions involve nervous system/psychiatric disorders, which are known effects of the medicine and are described in the approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) for Lariam. These reports describe a range of effects such as depression and associated effects such as agitation, abnormal dreams, insomnia, psychosis and suicidal thoughts. Other reactions reported to the IMB include symptoms such as fatigue, irritability, nausea and diarrhoea, which are also consistent with the known safety profile of Lariam.
The IMB has highlighted information relating to the safety of Lariam on a number of occasions, most recently in the 55th edition of its Drug Safety Newsletter published in June 2013, coinciding with the introduction of supplementary educational materials to support safe use of the product.
