Paroxetine must not be given to patients under 18
BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7402.1282-b (Published 12 June 2003) Cite this as: BMJ 2003;326:1282
The Medicines and Healthcare Products Regulatory Agency (MHRA) has advised that the antidepressant paroxetine (marketed as Seroxat) should not be prescribed for children or adolescents. It did so on the recommendation of an independent expert working group, commissioned by the Committee on Safety of Medicines (CSM).
Paroxetine, which is made by GlaxoSmithKline, has never been licensed for children, but about 8000 patients under 18 were taking paroxetine in the United Kingdom last year because it is legal to prescribe it if the doctor responsible deems it appropriate.
The new advice is based on studies showing that there are higher rates of suicidal thoughts and behaviour in the patients who took paroxetine (25 out of 738; 3.4%), compared with those who took placebo (8 out of 647; 1.2%). There was no case of an actual suicide in all the patients in these studies.
The MHRA emphasised that it was important that patients did not stop taking paroxetine abruptly. Instead, patients should seek their doctor's advice on how to taper off the drug. For some young patients who were already taking the drug “it might be favourable to continue with the drug, if they do not suffer from suicidal thoughts or behaviour,” said Dr Jonathan Chick, a psychiatrist on the CSM's expert working group on the issue.
A spokesman for the agency said that it was known that nine studies into the drug had been conducted, but the results of only one was “in the public domain.”
Professor Alasdair Breckenridge, the agency's chairman, said: “The Committee on Safety of Medicines will immediately investigate the relevance of these findings for the usage of paroxetine in adults.” He stated that “at the moment patients on paroxetine who do not show suicidal behaviour should continue taking it.”
Dr Alastair Benbow, head of European psychiatry for GlaxoSmithKline, issued the following statement: “While we believe that today's move will inevitably limit the choices available to doctors treating children and teenagers under 18 years with major depressive disorder, and the conclusions we draw from the data differ, we recognise the MHRA's decision for UK paediatric patients and we will work with them to implement the changes as soon as possible.”