Willie Penrose (Westmeath, Labour)
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Question 141: To ask the Minister for Health and Children if her attention has been drawn to the reported links of sudden deaths in children and an anti-influenza drug (details supplied); the measures in place to ensure the safety of persons who may have to use this drug; and if she will make a statement on the matter. [41464/06]

Mary Harney (Dublin Mid West, Progressive Democrats)
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The European Medicines Agency (EMEA) is responsible for the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. It co-ordinates the evaluation and supervision of medicinal products throughout the European Union and brings together the scientific resources of the 25 EU Member States in a network of 42 competent national authorities. A network of some 3,500 European experts underpins the scientific work of the EMEA and its committees.

Tamiflu is an antiviral drug approved in the European Union for the treatment of influenza in children between 1 and 13 years of age and for the prevention and treatment of influenza in adults and in adolescents over 13 years of age. Two cases of alleged suicide associated with the treatment of influenza (involving a 17 year old boy in February 2004 and a 14 year old boy in February 2005) were reported to the EMEA. In both cases the adolescents exhibited abnormal/disturbed behaviour prior to their deaths.

No causal relationship has been identified between the use of Tamiflu and psychiatric symptoms (such as hallucination and abnormal behaviour). All adverse reactions of Tamiflu are monitored and assessed by the Agency's scientific committee, the Committee for Medicinal Products for Human Use (CHMP) on a continuous basis. In addition, close monitoring of psychiatric disorders has been in place for Tamiflu since February 2003 at the request of the EMEA, following the safety information provided by the manufacturers November 2002.

The CHMP, at its meeting of 14-17 November 2005, decided to request the Marketing Authorisation Holder of Tamiflu to provide a cumulative safety review of all available data on serious psychiatric disorders, including all case reports with a fatal outcome where Tamiflu was involved. Further to the evaluation of the data submitted in November 2005, the CHMP concluded that close monitoring of psychiatric disorders should continue.

The Irish Medicines Board is the statutory body responsible for the regulation of human and veterinary medicines in Ireland. The Board works closely with both the EMEA and other European regulatory bodies on issues of safety concerning medicinal products. As with all medicinal products, the Board will continue to assess new information concerning Tamiflu and take appropriate action, where necessary.