UK says U.S. FDA
evaluating data on GSK's Seroxat
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.
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Medicines and Healthcare products Regulatory
Authority (MHRA) officials, addressing a news conference, said
Europe's CPMP expert committee on medicines had also been
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