GSK to remove Seroxat 'not addictive' claim

GlaxoSmithKline is to drop claims on patient information leaflets that its antidepressant Seroxat is not addictive.

The admission is to be made in a forthcoming BBC Panorama programme a follow-up to 'Secrets of Seroxat' shown in October and is the latest development in the high-profile battle between GSK and groups who claim severe withdrawal symptoms mean it is extremely difficult to come off the medication.

Numerous patients have reported serious side-effects when they try to come off the medication, but GSK has repeatedly said that this does not mean Seroxat causes addiction or dependency.

On 'Secrets of Seroxat' Dr Alastair Benbow, GSK's Head of European Clinical Psychiatry, said that the presence of withdrawal symptoms in some patients did not mean Seroxat was addictive according to the clinical definition of the word.

"Addiction is characterised by a number of different criteria, which include craving, which includes increasing the dose of drug to get the same effect, and a number of other features, and these are not exhibited by Seroxat", he said.

But GSK now admits that patients do not fully understand the wording of the PIL, and has decided to remove the leaflet claims that 'These tablets are not addictive'. However, the company will still keep this information on a separate information sheet for doctors.

A number of parallel developments have influenced the company's retreat on the matter.

Last year the company was found to be in breach of the pharma industry's advertising code of practice for understating the risk of dependence and withdrawal symptoms of Seroxat.

Meanwhile, a review by the Committee on the Safety of Medicines (CSM) into the whole SSRI class was scrapped in March when several conflicts of interests were discovered among the review body's members.

The inquiry began last November, but the revelation that two of its members failed to disclose financial ties with GSK has meant the investigation must be restarted.

Health consumer group Social Audit has been campaigning for a review of SSRIs, Seroxat in particular, for several years. Figures obtained by the group show that Seroxat is by far the most reported drug under the CSM's "Yellow Card" drug safety scheme. Almost 1,900 suspected adverse events were reported in 2001, compared with 272 for second-placed Efexor, Wyeth's rival SSRI.