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Medicinal Products.

Dáil Éireann Debate, Tuesday - 6 July 2004

Tuesday, 6 July 2004

Ceisteanna (312)

Jim O'Keeffe

Ceist:

345 Mr. J. O’Keeffe asked the Minister for Health and Children if his attention has been drawn to the fact that the warnings issued in the USA and Canada in relation to the use of antidepressants known as selective serotonin reuptake inhibitors are much stronger than those applicable here, or throughout the European Union; and if he will take steps to ensure that the documentation for the future will be more specific in relation to warnings and precautions for use of such drugs. [20125/04]

Amharc ar fhreagra

Freagraí scríofa

The Irish Medicines Board is the statutory body responsible for the safety of human medicinal products in Ireland. The IMB reviews all available data, from all sources, in monitoring the ongoing safety of medicinal products authorised for use in Ireland, with the specific aim of minimising the risk to patients while maximising the benefit of timely and appropriate treatment.

I am aware that the United States Food and Drug Administration issued a warning in March concerning the need for close observation of persons using antidepressant medication. The current Irish documentation for these types of product already contains such a warning, as well as a number of other special warnings and precautions for use.

The IMB will continue to review the safety of SSRIs and will take any regulatory action considered appropriate.

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