GSK will NOT remove the words 'not addictive' from in the summary of product characteristics provided to GPs

Seroxat firm to drop dependence claim


http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4001122#

18 May 03
GlaxoSmithKline will change the wording on the patient information leaflet for Seroxat (paroxetine) to remove the claim that the drug is 'not addictive'.
GSK made its decision after considering 1,400 e-mails from patients about their experiences of taking Seroxat, which were featured on BBC TV's Panorama earlier this month.
The company will not change the wording provided to GPs in the summary of product characteristics. A statement said: 'We acknowledge that patients may get symptoms on stopping Seroxat. Although we maintain Seroxat is not addictive, we have proposed to take out that specific wording as we realised on talking to patients it did not add to their understanding of what to expect when they stop taking the product.
'We are not proposing to change the wording to doctors on the SPC. The statement that Seroxat does not cause dependence will remain because this terminology is clearly understood by health care professionals.