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GlaxoSmithKline: Seroxat Has Side Effects In Children
Tuesday June 10, 7:23 am ET

LONDON -(Dow Jones)- GlaxoSmithKline PLC said Tuesday that its antidepressant drug Seroxat increased suicidal thinking among children when tested in trials.

GSK issued a statement after the U.K. government advised doctors not to prescribe the drug to children under the age of 18 because there was a risk of an increase in self-harm and suicidal behaviour.

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The move fell short of demands by patient group campaigners for a full ban on use of the drug, amid claims it has pushed some people to suicide and caused withdrawal problems in others.

GSK said clinical trials of the drug in adults had shown no evidence of an increased tendency to contemplate or attempt suicide. However, GSK said that in trials of children there was an increase in the incidence of suicidal thinking.

In a trial of 1,000 patients under the age of 18, there were no suicides. But the incidence of emotional side effects - ranging from mood swings to increased crying, to suicidal thoughts - was twice as high as in those taking a placebo.

GSK said while its conclusions from the data differed from those of the government's Medicines and Healthcare Products Regulatory Agency, it would work with the agency to implement the new guidelines as soon as possible.

Both the government and GSK urged patients to consult with their doctor before stopping taking the drug.

-By Susannah Rodgers, Dow Jones Newswires; 44 20 7842 9269; susannah.rodgers@dowjones.com


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