GPs were `absolutely not' at risk of any legal action as they were only following drug company information.

COPYRIGHT 2002 CMP Information Ltd.

GPs have been exonerated by the lawyer heading an impending group legal action against the manufacturer of Seroxat (paroxetine).

But he has warned GPs to be more alert to possible withdrawal symptoms of the drug.

Mark Harvey, partner at Cardiff law firm Hugh James, is pressing manufacturer Glaxo- SmithKline to bolster its `half-hearted' warnings on UK product literature, which states there is no suggestion of a link between withdrawal symptoms and dependency.

Mr Harvey claimed his investigation of the 80 cases so far involved in the group action revealed that GPs had often mistaken withdrawal effects as underlying illness and prescribed more of the drug. But he stressed GPs were `absolutely not' at risk of any legal action as they were only following drug company information.

`We feel the drug company is not giving out the right information,' he said.

Patients involved in the action - partly funded by legal aid - allege they suffered withdrawal effects including `electric zaps, dizziness, vertigo, agitation, aggression, nightmares and confusion'.

Mr Harvey said new cases were coming in daily. If the manufacturer refuses to strengthen the drug information and provide facilities to help patients withdraw, the group will seek compensation under the Consumer Protection Act for product liability.

In the US, warnings about Seroxat withdrawal were strengthened in December by the manufacturer at the request of the Food and Drug Administration.

Mr Harvey complained that warnings on the UK product were not as detailed.

`However you dress this up, doctors are not getting the message,' he said.

The UK summary of product characteristics for paroxetine advises `gradual discontinuation by dose-tapering'.

The Medicines Control Agency said it was continuing to monitor SSRIs. The Committee on Safety of Medicines, which has examined an alleged link between SSRIs and suicidal behaviour, has concluded that the matter must be kept under review.

Data from the Prescription Pricing Authority show nearly three-and-a- half million community prescriptions for paroxetine were written in 2000 in England alone.

A spokesman for GlaxoSmithKline said discontinuation symptoms were usually mild and self-limiting.

Copyright: CMP Information Ltd.


COPYRIGHT 2002 CMP Information Ltd.


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