§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)
My right honourable friend the Minister of State for Health (Mr Hutton) has made the following Written Ministerial Statement today.
Following continuing interest in both Houses about the issues surrounding the safety of Selective Serotonin Re-uptake Inhibitors (SSRIs), including Seroxat (paroxetine), this Statement informs the House of further conclusions of the Committee on Safety of Medicines (CSM) based on the work of the Expert Working Group on SSRIs.
In reviewing clinical trial data on the dosage of paroxetine and prescribing data suggesting that as many as 17,000 patients were started on doses above 20mg in the past year, the committee concluded that a reminder to prescribers was necessary in the following terms; that:
- (i) the starting dose of paroxetine in the treatment of depression should be 20mg, as per the current summary of products characteristics (SPC)
- (ii) there was no evidence from clinical trials of increased efficacy in the treatment of depressive illness above 20mg
- (iii) the adverse events that occur soon after starting therapy may be difficult to distinguish from the underlying condition. There is evidence that increasing the dose in this situation may be detrimental
- (iv) rapid upward titration may increase the risk of serious adverse events
- (v) those currently on a higher dose and responding well to treatment should remain on the same dose and be reviewed at their next regular treatment review.
- (vi) patients should not stop treatment suddenly. Any cessation of treatment should proceed by a gradual downward titration.
Detailed communications to patients and prescribers are taking place today. These will include a summary of clinical trial data on which the conclusions of the CSM and its expert group are based. This has been placed in the Library, and is available on the MHRA website.
The expert working group will continue its work to conclude its full review of the safety and efficacy of SSRIs and will examine what implications, if any, these latest findings have for the use of other SSRIs.