House of Commons Hansard Written Answers
Posted by shutah on March 16, 2007
26 Feb 2007 : Column 1127W
Caroline Flint:Since Paroxetine (brand name Seroxat) was first licensed its safety and that of other medicines in this class has been continually reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) and has been considered by the Committee on Safety of Medicines (CSM, the predecessor to the Commission on Human Medicines) on a number of occasions (in 1998, 1999, 2000 and 2001). In May 2003, in response to continuing public concern, an expert working group of the CSM was established to further review the safety of these medicines, with a particular focus on suicidal behaviour and the risk of withdrawal reactions.
The conclusions and key findings of the expert group were communicated to health professionals on 6 December 2004. Overall, the expert group concluded that the balance of risks and benefits of all selective serotonin reuptake inhibitors (SSRIs) in adults remains positive. The key findings of the expert group in relation to suicidal behaviour in adults concluded that based on the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self-harm for SSRIs compared with placebo cannot be ruled out. It was also recommended that prescribers and patients should be made more aware of the side effect profile of these medicines and recommended the need for close monitoring of patients, particularly young adults, being treated for depressive illness or anxiety disorders.
In reaching its conclusions the expert group considered a large body of evidence from a wide range of sources including spontaneous reports of adverse drug reactions (from health professionals and patients), clinical trials, epidemiological databases and the published literature. The published literature included studies which had examined the effect of recent increases in antidepressant prescribing (including SSRIs such as Paroxetine) on national suicide rates. With some exceptions, these studies generally conclude that recent rises in antidepressant prescribing have contributed to declines in suicide. Many factors influence suicide rates and generally definitive explanations for fluctuations in these rates cannot be ascertained. It is encouraging that the latest figures on suicide rates in England show that the national suicide rate continued to fall in 2005 and stood at its lowest ever level.
The safety of Paroxetine remains under continual review. The United States Food and Drug Administration has recently completed a review of adult clinical trials for SSRIs and related antidepressants examining the risk of suicidal thoughts and behaviour. These data are under consideration by the MHRA and other European regulatory authorities and new prescribing advice will be issued if any update is considered necessary.
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