21 September 2007
We received a petition asking:
"We the undersigned petition the Prime Minister to carry out a thorough investigation into the drug trials regarding Paroxetine/Seroxat/Paxil."
Details of Petition:
"Whilst the BBC Panorama journalist Shelley Jofre’s passionate reporting of Seroxat/Paxil/Paroxetine is highly commendable, the British Government owes the users of this drug a thorough investigation into GlaxoSmithKline drug trial information."
Read the Government’s response
The safety of Selective Serotonin Reuptake Inhibitors (SSRIs), including paroxetine, remains under constant scrutiny and the Government aims to ensure that healthcare professionals and patients are provided with information on their safe use as and when new data have arisen. A criminal investigation into an allegation that GlaxoSmithKline failed to supply pharmacovigilance information to the Medicines and Healthcare products Regulatory Agency (MHRA), relating to the paediatric use of Seroxat (paroxetine) was commenced on 1 October 2003. The investigation is still in progress.
The Government recognises the important role that SSRIs such as paroxetine (brand name Seroxat) play in the treatment of depressive illness and anxiety disorders. The safety of these medicines has been under continuous review by the UK regulatory body, the MHRA, since they were first marketed and new guidance has been issued as data accumulated.
In May 2003, the Government established an Expert Working Group of the independent scientific advisory committee, the Committee on Safety of Medicines (CSM), to further investigate the safety of SSRIs, with a particular focus on suicidal behaviour and withdrawal reactions. This review considered a large body of evidence including data from clinical trials, published literature, post-marketing studies, reports of patients’ experiences and feedback from meetings with patient support groups.
In 2003, upon the advice of the Expert Working Group, the MHRA was the first regulatory body to issue clear advice in 2003 on the risks and benefits of treatment with Seroxat and other SSRIs in the under 18 age group. It was recommended that, with the exception of fluoxetine, SSRIs should not be used in children and adolescents aged less than 18 years with depressive illness. This advice followed receipt of clinical trial data showing an increased rate of suicidal thoughts and behaviour in this population. Only fluoxetine has been shown to have a favourable balance of risks and benefits for the treatment of major depressive disorder in under 18s.
The conclusions and key findings of the Expert Group were communicated to health professionals on 6 December 2004. Overall, it was concluded that SSRIs are effective medicines in the treatment of depression and anxiety conditions, and that the balance of risks and benefits of all SSRIs in adults remains positive in their licensed indications. The Expert Working Group’s conclusions and the supporting evidence base were detailed in the Group’s comprehensive report published on 6 December 2004.