The European Medicines Agency scientific committee, the Committee for Medicinal Products for Human Use (CHMP), held an extraordinary meeting in London on 8 December 2004 and took two actions relating to paroxetine and to other SSRIs.
Firstly, the CHMP, at the request of the European Commission, re-examined its 22 April 2004 opinion on paroxetine in the light of additional information arising from newly available observational studies.
The CHMP, following the assessment of this additional information, confirmed its initial conclusion that the benefit/risk balance of paroxetine remains positive in the treatment of adults. The Committee also reaffirmed its previous conclusion that changes to the product information should be introduced, especially with regard to warnings of suicide-related behaviour in children and adolescents (see annex I for further details).
Secondly, following a request from the European Commission, the CHMP has also been reviewing the data available to national competent authorities for other SSRI1 and SNRI2 products particularly as regards their use in the paediatric population. The CHMP considers that on the basis of the available evidence there is a signal of an increase in suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with SSRIs and SNRIs. However, there were no deaths due to suicide in children or adolescents reported in the clinical trials (see annex II for further details).
The Committee will now inform the European Commission that there are public health concerns in relation to the safe use of these medicinal products in children and adolescents with depression, anxiety and related conditions, irrespective of the therapeutic indication. The CHMP will recommend to the European Commission that these concerns are further investigated at Community level.
Whilst further investigations at Community level are being conducted, the Committee already wishes to inform prescribers, patients and parents as follows:
SSRIs/SNRIs are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents.
These compounds should generally not be used in this age group because clinical trials have shown an increased risk of suicidal behaviour (such as suicide attempts and suicidal thoughts).
Nevertheless, a decision is sometimes taken, based on clinical need, to treat such patients. In these cases, the patient should be carefully monitored for the appearance of suicidal behaviour, self-harm and hostility. This is particularly important at the beginning of treatment.
The treatment should not be stopped by the patient or the parents without first seeking medical advice from the treating doctor because there is a risk of experiencing withdrawal symptoms, such as dizziness, sleep problems and anxiety if discontinuation is abrupt.
When treatment is being stopped, it is recommended to gradually reduce the dose over several weeks or months.
Patients or parents who have any concerns about the medication are advised to consult the treating doctor at the next available opportunity to discuss treatment.
The CHMP also discussed the rapid alert issued by the UK national competent authority relating to venlafaxine and concerns over cardiotoxicity and toxicity in overdose. The Committee recommends that this question as well as other safety issues concerning the use in adults of other SSRIs, including fluvoxamine, should be brought to the attention of its Pharmacovigilance Working Party for assessment.