Wednesday, 5 May 2010
Department of Health and Children
Jan O’Sullivan (Limerick East, Labour)
Question 194: To ask the Minister for Health and Children if she will ensure that the warning that is required by the Irish Medicines Board that certain anti-depressant drugs can cause suicidal ideation be made more prominent at the top of the information leaflet and laid out in bold type in order that it cannot be overlooked to ensure that tragedies are avoided due to the lack of knowledge of such possible side effects; and if she will make a statement on the matter. [18365/10]
Mary Harney (Minister, Department of Health and Children; Dublin Mid West, Independent)
The purpose of the package leaflet (patient information leaflet) for an authorised medicinal product is to provide comprehensive information on the side-effects of a medicine and recommendations for its safe and effective use. The aim is not only to ensure that potential risks are highlighted, but equally to support minimisation of risk through promoting compliance with the recommendations for use and monitoring requirements.
Leaflets must comply with Directive 2001/83/EC in terms of content and order of information. In addition, the package leaflet must be clear and understandable, enabling users to act appropriately, when necessary with the help of healthcare professionals. This ensures that the layout is consistent for all medicines across Europe, allowing patients to access information in a standardised format. The package leaflet is reviewed by the Irish Medicines Board (IMB) during the assessment process to ensure compliance with the legislative requirements.
The IMB has highlighted the risk of suicide and suicidal thoughts associated with use of antidepressants on a number of occasions, most recently in Drug Safety Newsletter in September 2008. The authorised package leaflet for this class of medicinal products contains information on what the patient should do if he/she experiences thoughts of suicide or worsening of depression.
O.K. So if the warnings are sufficient..How is it possible that psychiatry Ireland can deny this? How can Lundbeck come out on RTE and deny their drug can cause suicide ideation, never mind violence/mania. How was Shane supposed to know if even psychiatry claim not to? Leonie