| Previous Section | Index | Home Page |
Paroxetine
The Minister of State, Department of Health (Mr. John Hutton): 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 last 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);
11 Mar 2004 : Column 109WS
- (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 web-site.
The Expert Working Group will continue its work to conclude their 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.
11 Mar 2004 : Column 110WS
DEPUTY PRIME MINISTER
Professional Conduct Committee
The Parliamentary Under-Secretary of State, Office of the Deputy Prime Minister (Phil Hope): In July 2003, the Office of the Deputy Prime Minister consulted a number of professional organisations on a draft Statutory Instrument providing for the enlargement of the membership of the above Committee and amending the rules concerning its quorum. The responses to that consultation have now been lysed, and an amended Statutory Instrument was laid before Parliament yesterday.
The amendments to the draft Statutory Instrument are only minor and the effect remains that the pool of PCC members will be enlarged by seven additional persons. The Statutory Instrument will come into effect on 1 April 2004.
A number of consultees made other points concerning the Board, and one organisation requested a setting up of a Parliamentary Committee to investigate certain matters about the Board and its work. I have considered all of the representations received and have met the Chairman and other members of the Board to discuss. I have full confidence in the Board and the way it operates under the powers given in the Architects Act 1997 and have concluded that there is no need to set up such an inquiry.