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Published on 7 March 2008

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GSK rapped over dangers of Seroxat

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Glaxosmithkline (GSK) has been criticised by health regulators for withholding information over the risk of suicide relating to Seroxat (paroxetine).

The Medicines and Healthcare Products Regulatory Agency (MHRA) said it is concerned that the pharmaceutical giant failed to raise the alarm earlier over the side-effects of the antidepressant.

Public health minister Dawn Primarolo has now announced that new legislation will be introduced shortly to ensure that drug companies pass on results of clinical trials promptly.

Seroxat is the most frequently-prescribed antidepressant in the UK, but there have been reports that it can cause suicidal feelings in some patients.

The MHRA began an investigation in May 2003 over allegations that GSK knew of the drug’s dangers for several years, but failed to pass on the information.

Data from an earlier clinical trial had shown the drug could trigger a higher risk of suicidal behaviour in some cases.

Once the results were made known, the watchdog immediately warned doctors of the side-effects.

Dr Alastair Benbow, medical director for GSK Europe, said: “The safe use of our medicines is paramount to everyone who works for GSK.

“Whilst there are substantive and rigorous requirements in place regarding disclosure of clinical trial data, it is clear that there is a need and benefit to strengthen the confidence of decision-makers and the general public that all pharmaceutical industry clinical trial data are disclosed promptly and transparently.”

Copyright © PA Business 2008

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