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UK says U.S. FDA evaluating data on GSK's Seroxat
Reuters, 06.10.03, 5:59 AM ET


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LONDON, June 10 (Reuters) - Britain's drug regulatory agency said on Tuesday the U.S. Food and Drug Administration was evaluating data on GlaxoSmithKline Plc's <GSK.L> antidepressant Seroxat after the UK warned it should not be given to children.

Medicines and Healthcare products Regulatory Authority (MHRA) officials, addressing a news conference, said Europe's CPMP expert committee on medicines had also been alerted.

The MHRA recommended Seroxat should not be used to treat depression in people under 18 after new data showed an increase in the rate of self-harm and suicidal tendencies in those taking the drug in this age group.

Copyright 2003, Reuters News Service

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