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Markets : Market Features
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Problem With GlaxoSmithKline Depression Drug

By TSC Staff
06/10/2003 07:51 AM EDT

British drug giant GlaxoSmithKline (GSK:NYSE - news - commentary - research - analysis) conceded that its antidepressant Seroxat caused heightened suicidal thinking in some young patients, but urged that nobody stop using it before consulting with a doctor.

The statement follows a recommendation from the U.K. government that physicians stop prescribing the medication to people under 18. "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks," the government said.

GlaxoSmithKline, for whom Seroxat is its second-biggest drug, stressed that the effects were found only in children and adolescents and said there's no good evidence that it causes actual suicides. The drug is called Paxil in the U.S.

"In our paediatric trials, which included over 1,000 patients treated with paroxetine, not a single person committed suicide," the company said. "However, in our pediatric trials for patients with depression we have seen a difference between Seroxat and placebo in terms of suicidal thinking or attempts, particularly in adolescents."

"While we believe that today's move will inevitably limit the choices available to doctors treating children and teenagers under 18 years with major depressive disorder, and the conclusions we draw from the data differ, we recognize the MHRA's decision for U.K. paediatric patients and we will work with them to implement the changes as soon as possible."

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