CSM EWG 3rd meeting - June 20 2003
http://www.mhra.gov.uk/home/groups/pl-p/documents/committeedocument/con003485.pdf
7.3 SSRIs and suicide 7.3.1 Dr Healy presented data on fluoxetine and suicide and suicidal acts from clinical trials which showed no apparent difference in the percentage of suicides and suicidal acts between fluoxetine and ‘comparator’ when ‘comparator’ included all the times the patients were not on fluoxetine. However an apparent increase in the percentage of suicides and suicidal acts with fluoxetine was seen when ‘washout/run in’ and ‘other’ periods were excluded from the ‘comparator’ group.
7.3.2 Dr Healy believed that because patients may be at greater risk of suicide on starting and stopping treatment it was more appropriate to consider absolute numbers of events rather than present data using patient exposure years. Dr Healy also considered that it was important to take dose-response data into account.
7.3.3 Dr Healy presented further data on paroxetine and sertraline from clinical trials which also suggested an increase in the percentage of suicides and suicidal acts with paroxetine and sertraline compared with placebo when the washout/run in periods were separated from the comparator group in the analysis.
7.3.4 Dr Healy reported that Pfizer had judged that there was a causal relationship between sertraline and suicidal events in a number of cases in their clinical trials. He was unable present these data in full at the meeting as the data were confidential.
7.3.5 Dr Healy also presented data on citalopram and venlafaxine which showed an apparent increase in percentage of suicide and suicidal acts with these drugs compared with placebo. He said that combined data on all SSRIs also suggested an increase in percentage of suicide and suicidal acts with all SSRIs compared with placebo.
7.3.6 Dr Healy finished his presentation by stating that in his view there is now enough evidence to show that SSRIs may be causally associated with suicide and that patients would be helped by better product information.
http://www.mhra.gov.uk/home/groups/pl-p/documents/committeedocument/con003485.pdf
7.3 SSRIs and suicide 7.3.1 Dr Healy presented data on fluoxetine and suicide and suicidal acts from clinical trials which showed no apparent difference in the percentage of suicides and suicidal acts between fluoxetine and ‘comparator’ when ‘comparator’ included all the times the patients were not on fluoxetine. However an apparent increase in the percentage of suicides and suicidal acts with fluoxetine was seen when ‘washout/run in’ and ‘other’ periods were excluded from the ‘comparator’ group.
7.3.2 Dr Healy believed that because patients may be at greater risk of suicide on starting and stopping treatment it was more appropriate to consider absolute numbers of events rather than present data using patient exposure years. Dr Healy also considered that it was important to take dose-response data into account.
7.3.3 Dr Healy presented further data on paroxetine and sertraline from clinical trials which also suggested an increase in the percentage of suicides and suicidal acts with paroxetine and sertraline compared with placebo when the washout/run in periods were separated from the comparator group in the analysis.
7.3.4 Dr Healy reported that Pfizer had judged that there was a causal relationship between sertraline and suicidal events in a number of cases in their clinical trials. He was unable present these data in full at the meeting as the data were confidential.
7.3.5 Dr Healy also presented data on citalopram and venlafaxine which showed an apparent increase in percentage of suicide and suicidal acts with these drugs compared with placebo. He said that combined data on all SSRIs also suggested an increase in percentage of suicide and suicidal acts with all SSRIs compared with placebo.
7.3.6 Dr Healy finished his presentation by stating that in his view there is now enough evidence to show that SSRIs may be causally associated with suicide and that patients would be helped by better product information.
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