New warning on dangers of paroxetine
A European-wide review of paroxetine (Seroxat) has found the drug might increase the risk of suicide-related behaviour in young adults.
After reviewing published and unpublished scientific data, the EU's drug advisory body also wants stronger warnings about the dangers of sudden withdrawal from the drug included in product information.
The call, which is expected to be rubber-stamped by the European Commission within months, pre-empts the UK's expert working group on
SSRIs which continues to investigate safety concerns surrounding paroxetine and other antidepressants.
The findings of the Committee for Proprietary Medicinal Products will increase pressure on the working group to tighten advice on paroxetine, especially as it found there was a 'possibility of an increased risk of suicide-related behaviour in young adults' who should be monitored carefully throughout treatment.
So far the working group has banned the use of paroxetine in the under-18s and reiterated advice on starting doses and gradually reducing doses to step patients off the drug.
Current product information does contain warnings about the dangers of stopping SSRIs too abruptly and the necessity of carefully monitoring patients, but only until an improvement occurs.
BNF information does not stipulate the careful monitoring of patients.
The EC review is legally binding and will require manufacturer GSK to step up product information warnings but will only have the status of guidance for prescribers.
Medicolegal advisers said that neither European nor British prescribing advice took precedence over one another and that GPs should be guided by what they thought to be the most appropriate and authoritative advice.
Some GP SSRI experts complained that the European advice, which found the benefit/risk profile for paroxetine was favourable, did not go far enough to protect patients.
Former GP Dr Andrew Herxheimer of the department of primary care at the University of Oxford, said the findings were a 'small step in the right direction'. But he said the CSM working group should do 'something more effective' and prevent new patients being given paroxetine.
GSK said a paragraph would be added to its product information about close monitoring.
By Cato Pedder