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Drug guidelines to be tightened following Seroxat suicide probe

  • 2 Comments

The government’s drugs watchdog has said it will call for tighter regulations on reporting of clinical trials following an investigation into whether drug manufacturer GlaxoSmithKline buried concerns that the antidepressant paroxetine (Seroxat), caused suicidal ideation in children.

The ruling follows a criminal investigation launched in 2003 into whether GSK withheld information from the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA had been monitoring the safety of Seroxat since it was launched in the early nineties.

MHRA chief executive Kent Woods said: ‘We will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies’ obligations to report safety issues.’

Government legal experts have ruled that there will be no criminal charges against GSK.

  • 2 Comments

Readers' comments (2)

  • So what is being said here. Is Seroxat dangerous to give to young people, and why ? If it is, why is the Drug firm allowed to carry on without Government sanction.Is it because the whole buisness is about Mentally ill people, so there is no need to treat it seriously?
    Glyn Goodchild. RMN.

    Unsuitable or offensive? Report this comment

  • So what is being said here. Is Seroxat dangerous to give to young people, and why ? If it is, why is the Drug firm allowed to carry on without Government sanction.Is it because the whole buisness is about Mentally ill people, so there is no need to treat it seriously?
    Glyn Goodchild. RMN.

    Unsuitable or offensive? Report this comment

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