HC Deb 26 March 2004 vol 419 c1136W
Paul Flynn

: To ask the Secretary of State for Health when the data on which the Medicines and Healthcare Products Regulatory Agency based its statement of 11 March on dosage levels of Seroxat was first made available to the regulator. [162491]

Ms Rosie Winterton

: The advice issued by the Committee for the Safety of Medicines (CSM) on 11 March 2004 followed a re-evaluation of the original dose finding studies carried out for the licensing of paroxetine in 1990. This forms part of the ongoing in-depth review of the safety of selective serotonin reuptake inhibitors (SSRIs), including paroxetine (Seroxat), by the CSM's expert working group on the safety of SSRIs.

The expert group initially reviewed one of the dose finding studies for paroxetine in October 2003. On the advice of the expert group, the manufacturer was then asked to provide data to justify the current dosing recommendations for all indications as part of the European review of the risks and benefits of paroxetine. The expert group reviewed all the information available at its meeting on 27 February 2004.

On 10 March 2004, the CSM endorsed the advice of its expert group and advised that public communication was necessary on the basis of the re-evaluation of clinical trial data and the evidence of prescribing of paroxetine outside of the recommendations in the summary of product characteristics, in particular the use of starting doses above 20 mg in the treatment of depression.

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